<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04421820</url>
  </required_header>
  <id_info>
    <org_study_id>BOLD-100-001</org_study_id>
    <nct_id>NCT04421820</nct_id>
  </id_info>
  <brief_title>BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours</brief_title>
  <official_title>A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bold Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bold Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based&#xD;
      small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in&#xD;
      tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined&#xD;
      with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure&#xD;
      tolerability and safety, followed by a cohort expansion phase.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">August 28, 2020</start_date>
  <completion_date type="Anticipated">September 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of dose-limiting toxicities (DLT)</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results (chemistry, hematology, coagulation, urinalysis), Eastern Cooperative Oncology Group (ECOG) performance status</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival (PFS); Overall Response Rate (ORR); Overall Survival (OS)</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard PK parameters including Cmin</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline GRP78 biomarker levels (Counts/mL)</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in GRP78 biomarker levels during treatment (Counts/mL)</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard PK parameters including Cmax</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard PK parameters including TSS</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard PK parameters including CSS</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Standard PK parameters including Vdss</measure>
    <time_frame>Screening to Study Discontinuation (an average of 2 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>10</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Pancreatic Cancer</condition>
  <condition>Gastric Cancers</condition>
  <condition>Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>Part B - Dose Expansion - 1L Gastric Cancer (ARM I)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Dose Expansion - 2L Gastric Cancer (ARM II)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Open to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A - Dose Escalation - Gastric Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A - Dose Escalation - Pancreatic Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A - Dose Escalation - Colorectal Cancer</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Part A - Dose Escalation - Cholangiocarcinoma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm closed to enrollment.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BOLD-100 in combination with FOLFOX Chemotherapy (Dose Expansion)</intervention_name>
    <description>625 mg/m2 IV over 30 minutes, q2weeks</description>
    <arm_group_label>Part B - Dose Expansion - 1L Gastric Cancer (ARM I)</arm_group_label>
    <arm_group_label>Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)</arm_group_label>
    <arm_group_label>Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)</arm_group_label>
    <arm_group_label>Part B - Dose Expansion - 2L Gastric Cancer (ARM II)</arm_group_label>
    <arm_group_label>Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)</arm_group_label>
    <arm_group_label>Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>BOLD-100 in combination with FOLFOX Chemotherapy (Dose Escalation)</intervention_name>
    <description>320 mg/m2 IV over 30 minutes, q2weeks; 420 mg/m2 IV over 30 minutes, q2weeks; 500 mg/m2 IV over 30 minutes, q2weeks; 625 mg/m2 IV over 30 minutes, q2weeks</description>
    <arm_group_label>Part A - Dose Escalation - Cholangiocarcinoma</arm_group_label>
    <arm_group_label>Part A - Dose Escalation - Colorectal Cancer</arm_group_label>
    <arm_group_label>Part A - Dose Escalation - Gastric Cancer</arm_group_label>
    <arm_group_label>Part A - Dose Escalation - Pancreatic Cancer</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be 18 years or older.&#xD;
&#xD;
          2. Be male or non-pregnant females who agree to comply with applicable contraceptive&#xD;
             requirements of the protocol (see Table 12. Acceptable Contraceptive Methods.)&#xD;
&#xD;
          3. Histologically and/or cytologically confirmed gastrointestinal tumours that are&#xD;
             metastatic or unresectable, and are subject to receive FOLFOX as SOC per&#xD;
             investigator's judgement. Participants will have received at least one line of&#xD;
             chemotherapy in the metastatic setting. Colorectal cancer: Patients must have received&#xD;
             at least 1 prior line of therapy prior to enrollment in this study. Pancreatic cancer:&#xD;
             Patients must have received at least 1 prior line of therapy. Gastric cancer: Patients&#xD;
             who have not received prior treatment may be included in this study. GEJ&#xD;
             (gastroesophageal junction) cancer patients are considered eligible to enter this&#xD;
             trial. Cholangiocarcinoma: locally advanced or metastatic biliary tract cancer (intra&#xD;
             or extrahepatic cholangiocarcinoma or gallbladder cancer) are eligible to enter this&#xD;
             trial. Patients must have received at least 1 prior line of therapy (with&#xD;
             gemcitabine-based chemotherapy). Colorectal cancer (ARM VI): Patients must have&#xD;
             received at least 2 prior lines of therapy prior to enrollment in this study, one of&#xD;
             which was a 5-FU based regimen.&#xD;
&#xD;
          4. Have measurable disease according to RECIST v1.1 (at least one measurable lesion).&#xD;
&#xD;
          5. Have an anticipated survival of at least 16 weeks.&#xD;
&#xD;
          6. Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of&#xD;
             0 or 1.&#xD;
&#xD;
          7. Have adequate organ function, defined as:&#xD;
&#xD;
               1. Hematologic: ANC ≥ 1.5 x 109/L, Hgb ≥ 9.0 g/dL and platelet count ≥ 100 x 109/L&#xD;
&#xD;
               2. Hepatic: total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for subjects with Gilbert's&#xD;
                  Syndrome); transaminases ≤ 2.5 x ULN (may be up to ≤ 5x ULN if clearly due to&#xD;
                  liver metastases) and ALP ≤ 2.5 x ULN (or ≤ 3 x ULN if liver metastases).&#xD;
&#xD;
               3. Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min.&#xD;
&#xD;
             c. Urine protein is 0, trace, or +1 on dipstick urinalysis, or &lt; 1.0 gram on 24-hour&#xD;
             urine protein analysis&#xD;
&#xD;
          8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug&#xD;
             excretion (e.g., non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates,&#xD;
             diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be&#xD;
             initiated while the subject is participating in this study or have been initiated&#xD;
             within 30 days beforehand before the start of treatment. Whenever possible, narcotic&#xD;
             analgesic doses should be stable within 30 days prior to study entry and during the&#xD;
             first cycle of therapy.&#xD;
&#xD;
          9. Resolved acute effects of any prior therapy before the start of treatment to baseline&#xD;
             severity or grade ≤1 CTCAE 5.0 except for adverse events not constituting a safety&#xD;
             risk by investigator judgment (such as alopecia)&#xD;
&#xD;
         10. Able to take oral medications (for pre-medications and supportive management)&#xD;
&#xD;
         11. Understand and be able, willing, and likely to fully comply with study procedures and&#xD;
             restrictions.&#xD;
&#xD;
         12. Be fully informed about their illness and the investigational nature of the study&#xD;
             protocol, and sign a REB-approved Informed Consent Form (ICF).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Neuropathy &gt; grade 2&#xD;
&#xD;
          2. Previous intolerance to or significant reaction secondary to fluorouracil or&#xD;
             oxaliplatin&#xD;
&#xD;
          3. Cerebrovascular accident within the past 6 months before the start of treatment.&#xD;
&#xD;
          4. History or presence of central nervous system (CNS) metastasis or leptomeningeal&#xD;
             tumours as documented by CT or MRI scan, analysis of cerebrospinal fluid or&#xD;
             neurological exam.&#xD;
&#xD;
          5. Any serious medical conditions that might be aggravated by treatment or limit&#xD;
             compliance. This includes, but is not limited to uncontrolled psychiatric disorders,&#xD;
             serious infections, active peptic ulcer disease and bleeding diathesis&#xD;
&#xD;
          6. Any history of serious cardiac illness including (but not confined to):&#xD;
&#xD;
               -  Previous or active myocardial infarction &lt; 6 months before the start of treatment&#xD;
&#xD;
               -  Congestive cardiac failure (NYHA III or IV)&#xD;
&#xD;
               -  History of unstable angina pectoris &lt; 6 months before the start of treatment&#xD;
&#xD;
               -  Recent coronary artery bypass grafting &lt; 6 months before the start of treatment&#xD;
&#xD;
               -  Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg)&#xD;
&#xD;
               -  Ventricular arrhythmia &lt; 6 months before the start of treatment&#xD;
&#xD;
               -  Left ventricular ejection fraction (LVEF) &lt; 50% as measured either by&#xD;
                  radionuclide angiography or echocardiogram&#xD;
&#xD;
               -  QTc interval &gt; 470 msec&#xD;
&#xD;
          7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the&#xD;
             past 6 months before the start of treatment&#xD;
&#xD;
          8. Any other known malignancy within 3 years before the start of treatment (with the&#xD;
             exception of non-melanoma skin cancer that had undergone curative treatment, cervical&#xD;
             cancer in situ, or ductal/lobular carcinoma in situ of the breast that has underwent&#xD;
             local treatment&#xD;
&#xD;
          9. Active gastrointestinal tract disease with malabsorption syndrome.&#xD;
&#xD;
         10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular&#xD;
             disease.&#xD;
&#xD;
         11. Treatment with radiation therapy or surgery within 4 weeks prior to starting&#xD;
             treatment.&#xD;
&#xD;
         12. Recent history of weight loss &gt; 10% of current body weight in past 3 months before the&#xD;
             start of treatment.&#xD;
&#xD;
         13. Current (within 1 week of the start of the study) or regular use of any medication&#xD;
             (including OTC, herbal or homeopathic preparations) that could affect (improve or&#xD;
             worsen) the cancer being studied, or could affect the action or disposition of&#xD;
             BOLD-100, or its clinical or laboratory assessment, e.g., Coumadin therapy, due to&#xD;
             high competitive protein binding.&#xD;
&#xD;
         14. HIV-positive subjects on combination anti-retroviral therapy due to the potential for&#xD;
             PK interactions with the study agent.&#xD;
&#xD;
         15. Any condition potentially decreasing compliance to study procedures. Concurrent use of&#xD;
             another investigational therapy or anti-cancer therapy.&#xD;
&#xD;
         16. Concurrent use of another investigational therapy or anti-cancer therapy within 4&#xD;
             weeks before the start of treatment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cross Cancer Institue</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juravinski Cancer Centre</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Ottawa Hospital Cancer Centre</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish General Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McGill University Health Centre Glen Site</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center</name>
      <address>
        <city>Goyang</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital - Yonsei University</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>Korea, Republic of</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 15, 2023</last_update_submitted>
  <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leucovorin</mesh_term>
    <mesh_term>Fluorouracil</mesh_term>
    <mesh_term>Oxaliplatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04421820
org study id: BOLD-100-001
nct id: NCT04421820
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
BOLD-100 is an intravenously administered sterile solution containing the ruthenium-based
      small molecule. BOLD-100 has been shown to preferentially decrease the expression of GRP78 in
      tumour cells and ER stressed cells when compared to normal cells. BOLD-100 will be combined
      with cytotoxic FOLFOX chemotherapy in this study, with a dose escalation cohort to ensure
      tolerability and safety, followed by a cohort expansion phase.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Incidence of serious adverse events (SAE) and suspected unexpected serious adverse reactions;
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Incidence of dose-limiting toxicities (DLT)
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Incidence of clinically significant changes or abnormalities from Physical Examinations, ECGs, Vital Signs, Laboratory Results (chemistry, hematology, coagulation, urinalysis), Eastern Cooperative Oncology Group (ECOG) performance status
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Progression Free Survival (PFS); Overall Response Rate (ORR); Overall Survival (OS)
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Standard PK parameters including Cmin
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Baseline GRP78 biomarker levels (Counts/mL)
time frame: Baseline
measure: Changes in GRP78 biomarker levels during treatment (Counts/mL)
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Standard PK parameters including Cmax
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Standard PK parameters including TSS
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Standard PK parameters including CSS
time frame: Screening to Study Discontinuation (an average of 2 months)
measure: Standard PK parameters including Vdss
time frame: Screening to Study Discontinuation (an average of 2 months)
arm group label: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)
arm group type: Experimental
description: Arm closed to enrollment.
arm group label: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)
arm group type: Experimental
description: Open to enrollment.
arm group label: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)
arm group type: Experimental
description: Arm closed to enrollment.
arm group label: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)
arm group type: Experimental
description: Arm closed to enrollment.
arm group label: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)
arm group type: Experimental
description: Open to enrollment.
arm group label: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)
arm group type: Experimental
description: Arm closed to enrollment.
arm group label: Part A - Dose Escalation - Gastric Cancer
arm group type: Experimental
description: Arm closed to enrollment.
arm group label: Part A - Dose Escalation - Pancreatic Cancer
arm group type: Experimental
description: Arm closed to enrollment.
arm group label: Part A - Dose Escalation - Colorectal Cancer
arm group type: Experimental
description: Arm closed to enrollment.
arm group label: Part A - Dose Escalation - Cholangiocarcinoma
arm group type: Experimental
description: Arm closed to enrollment.
intervention type: Drug
intervention name: BOLD-100 in combination with FOLFOX Chemotherapy (Dose Expansion)
description: 625 mg/m2 IV over 30 minutes, q2weeks
arm group label: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)
arm group label: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)
arm group label: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)
arm group label: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)
arm group label: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)
arm group label: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)
intervention type: Drug
intervention name: BOLD-100 in combination with FOLFOX Chemotherapy (Dose Escalation)
description: 320 mg/m2 IV over 30 minutes, q2weeks; 420 mg/m2 IV over 30 minutes, q2weeks; 500 mg/m2 IV over 30 minutes, q2weeks; 625 mg/m2 IV over 30 minutes, q2weeks
arm group label: Part A - Dose Escalation - Cholangiocarcinoma
arm group label: Part A - Dose Escalation - Colorectal Cancer
arm group label: Part A - Dose Escalation - Gastric Cancer
arm group label: Part A - Dose Escalation - Pancreatic Cancer
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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facility: 
country: Canada
country: Korea, Republic of
country: United States
responsible party type: Sponsor
mesh term: Cholangiocarcinoma
mesh term: Leucovorin
mesh term: Fluorouracil
mesh term: Oxaliplatin
sharing ipd: Undecided