A Phase 1b/2a Dose Escalation Study of BOLD-100 in Combination With FOLFOX Chemotherapy in Patients With Advanced Solid Tumours

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Be 18 years or older.

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

• Histologically and/or cytologically confirmed gastrointestinal tumours that are metastatic or unresectable, and are subject to receive FOLFOX as SOC per investigator's judgement. Participants will have received at least one line of chemotherapy in the metastatic setting. 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. GEJ (gastroesophageal junction) cancer patients are considered eligible to enter this trial. Cholangiocarcinoma: locally advanced or metastatic biliary tract cancer (intra or extrahepatic cholangiocarcinoma or gallbladder cancer) are eligible to enter this trial. Patients must have received at least 1 prior line of therapy (with gemcitabine-based chemotherapy). Colorectal cancer (ARM VI): Patients must have received at least 2 prior lines of therapy prior to enrollment in this study, one of which was a 5-FU based regimen. Colorectal cancer (ARM VII): Patients must have received only 1 prior line of therapy in the metastatic setting but remain naïve to oxaliplatin prior to enrollment in this study.

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

• Have an anticipated survival of at least 16 weeks.

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

• Have adequate organ function, defined as:

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

‣ Hepatic: total bilirubin ≤ 1.5 x ULN (or ≤ 3 x ULN for subjects with Gilbert's Syndrome); transaminases ≤ 2.5 x ULN (may be up to ≤ 5x ULN if clearly due to liver metastases) and ALP ≤ 2.5 x ULN (or ≤ 3 x ULN if liver metastases).

‣ 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

• 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 before the start of treatment. Whenever possible, narcotic analgesic doses should be stable within 30 days prior to study entry and during the first cycle of therapy.

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

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

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

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

⁃ (ARM VII): BRAF wild-type tumour status

Locations
United States
California
University of California, Los Angeles
COMPLETED
Santa Monica
Florida
Moffitt Cancer Center
COMPLETED
Tampa
Other Locations
Canada
Cross Cancer Institue
RECRUITING
Edmonton
Juravinski Cancer Centre
RECRUITING
Hamilton
Jewish General Hospital
RECRUITING
Montreal
McGill University Health Centre Glen Site
RECRUITING
Montreal
The Ottawa Hospital Cancer Centre
RECRUITING
Ottawa
Princess Margaret Cancer Centre
RECRUITING
Toronto
Ireland
St. James Hospital
RECRUITING
Dublin
Republic of Korea
National Cancer Center
RECRUITING
Goyang
Kangbuk Samsung Hospital
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital - Yonsei University
RECRUITING
Seoul
Contact Information
Primary
Michelle Jones
clinical@bold-therapeutics.com
604-262-9899
Backup
Jim Pankovich
jp@bold-therapeutics.com
604-262-9934
Time Frame
Start Date: 2020-08-28
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 220
Treatments
Experimental: Part B - Dose Expansion - 1L Gastric Cancer (ARM I)
Arm closed to enrollment.
Experimental: Part B - Dose Expansion - 2L Gastric Cancer (ARM II)
Arm closed to enrollment.
Experimental: Part B - Dose Expansion - 2L Pancreatic Cancer (ARM III)
Arm closed to enrollment.
Experimental: Part B - Dose Expansion - 2L Colorectal Cancer (ARM IV)
Arm closed to enrollment.
Experimental: Part B - Dose Expansion - 3L Colorectal Cancer (ARM VI)
Arm closed to enrollment.
Experimental: Part B - Dose Expansion - 2L Cholangiocarcinoma (ARM V)
Arm closed to enrollment.
Experimental: Part A - Dose Escalation - Gastric Cancer
Arm closed to enrollment.
Experimental: Part A - Dose Escalation - Pancreatic Cancer
Arm closed to enrollment.
Experimental: Part A - Dose Escalation - Colorectal Cancer
Arm closed to enrollment.
Experimental: Part A - Dose Escalation - Cholangiocarcinoma
Arm closed to enrollment.
Active_comparator: Part B - Dose Expansion - 2L Colorectal Cancer (ARM VII) - Randomized
Arm open to enrollment.
Sponsors
Leads: Bold Therapeutics, Inc.

This content was sourced from clinicaltrials.gov

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