BOLD-100 in Combination With FOLFOX for the Treatment of Advanced, Solid Tumours

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Brief Title

BOLD-100 in Combination With FOLFOX for the Treatment of Advanced Solid Tumours

Official Title

A Phase 1b Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

Brief Summary

      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.
    


Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Incidence and severity of adverse events (AEs) according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0

Secondary Outcome

 Progression Free Survival (PFS); Overall Response Rate (ORR); Overall Survival (OS)

Condition

Colorectal Cancer

Intervention

BOLD-100 in combination with FOLFOX Chemotherapy

Study Arms / Comparison Groups

 Gastric Cancer
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

80

Start Date

August 28, 2020

Completion Date

March 31, 2022

Primary Completion Date

December 31, 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Be 18 years or older.

          2. Be male or non-pregnant females who agree to comply with applicable contraceptive
             requirements of the protocol (see Table 12. Acceptable Contraceptive Methods.)

          3. Histologically and/or cytologically confirmed gastrointestinal tumours that are
             metastatic or unresectable, and have received at least one line of chemotherapy in the
             metastatic setting (in the dose escalation phase only). For the dose expansion phase,
             the setting will vary based on the malignancy. Colorectal cancer: Patients must have
             received at least 1 prior line of therapy prior to enrollment in this study.
             Pancreatic cancer: Patients must have received at least 1 prior line of therapy.
             Gastric cancer: Patients who have not received prior treatment may be included in this
             study. Cholangiocarcinoma: Patients must have received at least 1 prior line of
             therapy (with gemcitabine-based chemotherapy).

          4. Have measurable disease according to RECIST v1.1 (at least one measurable lesion).

          5. Have an anticipated survival of at least 16 weeks.

          6. Be ambulatory, with an Eastern Cooperative Oncology Group (ECOG) performance score of
             0 or 1.

          7. Have adequate organ function, defined as:

               1. Hematologic: ANC ≥ 1.5 x 109/L, Hgb ≥ 9.0 g/dL and platelet count ≥ 100 x 109/L

               2. Hepatic: total bilirubin ≤ 1.5 x ULN; transaminases ≤ 2.5 x ULN (may be up to 5 x
                  ULN if clearly due to liver metastases), ALP ≤ 2.5 x ULN

               3. Renal: serum creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 50 mL/min.

             c. Urine protein is 0, trace, or +1 on dipstick urinalysis, or < 1.0 gram on 24-hour
             urine protein analysis

          8. Be on stable doses of any drugs that may affect hepatic drug metabolism or renal drug
             excretion (e.g., non-steroidal anti-inflammatory drugs, corticosteroids, barbiturates,
             diphenylhydantoin, narcotic analgesics, probenecid). Such drugs should not be
             initiated while the subject is participating in this study or have been initiated
             within 30 days beforehand. Whenever possible, narcotic analgesic doses should be
             stable within 30 days prior to study entry and during the first cycle of therapy.

          9. Resolved acute effects of any prior therapy to baseline severity or grade ≤1 CTCAE 5.0
             except for adverse events not constituting a safety risk by investigator judgment
             (such as alopecia)

         10. Able to take oral medications (for pre-medications and supportive management)

         11. Understand and be able, willing, and likely to fully comply with study procedures and
             restrictions.

         12. Be fully informed about their illness and the investigational nature of the study
             protocol, and sign a REB-approved Informed Consent Form (ICF).

        Exclusion Criteria:

          1. Neuropathy > grade 2

          2. Previous intolerance to or significant reaction secondary to fluorouracil or
             oxaliplatin

          3. Cerebrovascular accident within the past 6 months.

          4. History or presence of central nervous system (CNS) metastasis or leptomeningeal
             tumours as documented by CT or MRI scan, analysis of cerebrospinal fluid or
             neurological exam.

          5. Any serious medical conditions that might be aggravated by treatment or limit
             compliance. This includes, but is not limited to uncontrolled psychiatric disorders,
             serious infections, active peptic ulcer disease and bleeding diathesis

          6. Any history of serious cardiac illness including (but not confined to):

               -  Previous or active myocardial infarction < 6 months

               -  Congestive cardiac failure (NYHA III or IV)

               -  History of unstable angina pectoris < 6 months

               -  Recent coronary artery bypass grafting < 6 months

               -  Uncontrolled hypertension (systolic ≥ 140 mmHg or diastolic ≥ 90 mmHg)

               -  Ventricular arrhythmia < 6 months

               -  Left ventricular ejection fraction (LVEF) < 50% as measured either by
                  radionuclide angiography or echocardiogram

               -  QTc interval > 470 msec

          7. Hemoptysis, cerebral, or clinically significant gastrointestinal hemorrhage in the
             past 6 months

          8. Any other known malignancy within 3 years (with the exception of non-melanoma skin
             cancer that had undergone curative treatment, cervical cancer in situ, or
             ductal/lobular carcinoma in situ of the breast that has underwent local treatment

          9. Active gastrointestinal tract disease with malabsorption syndrome.

         10. Non-healing wound, fracture, or ulcer, or presence of symptomatic peripheral vascular
             disease.

         11. Treatment with radiation therapy or surgery within one month prior to study entry.

         12. Recent history of weight loss > 10% of current body weight in past 3 months.

         13. Current (within 1 week of the start of the study) or regular use of any medication
             (including OTC, herbal or homeopathic preparations) that could affect (improve or
             worsen) the cancer being studied, or could affect the action or disposition of
             BOLD-100, or its clinical or laboratory assessment, e.g., Coumadin therapy, due to
             high competitive protein binding. Subjects taking ANY supplemental IRON, i.e.,
             therapeutic or as part of a multivitamin regimen, are excluded from this study,
             whether prescribed or self-medicated.

         14. HIV-positive subjects on combination anti-retroviral therapy due to the potential for
             PK interactions with the study agent.

         15. Any condition potentially decreasing compliance to study procedures. Concurrent use of
             another investigational therapy or anti-cancer therapy.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, 604-262-9899, [email protected]

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT04421820

Organization ID

BOLD-100-001


Responsible Party

Sponsor

Study Sponsor

Bold Therapeutics, Inc.


Study Sponsor

, , 


Verification Date

October 2020