BET Inhibitors for Pediatric Solid Cancers

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen bySteven G. DuBois, MD, MS

Age: < 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?

Arm 1 of this research study is studying an investigational drug called BMS-986158 as a possible treatment for pediatric solid tumors or lymphoma. Arm 2 of this research study is studying an investigational drug called BMS-986378 (also known as CC-90010) as a possible treatment for pediatric brain tumors or pediatric tumors that have spread to the brain.

Research Team

Steven G. DuBois, MD, MS

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for children and young adults up to 21 years old with certain types of cancer, including solid tumors, lymphoma, or brain tumors. They must have relapsed or refractory disease where standard treatments are ineffective. Participants need normal organ function and the ability to swallow pills. Those who've had recent other treatments or surgeries must wait specific periods before joining.

Inclusion Criteria

My cancer has a high level of the MYCN gene.

My cancer involves a change in the MYC or MYCN gene.

I have recovered from side effects of previous cancer treatments, except for issues related to organ function.

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Exclusion Criteria

I have not taken certain medications, grapefruit, Seville oranges, NSAIDs, oral anticoagulants, heparins, or other investigational drugs recently.

I have a history of HIV, hepatitis B, or hepatitis C.

My body surface area is less than 0.3 m2, except for specific doses where it must be over 0.71 m2.

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Treatment Details

Interventions

BMS-986158 (Bromodomain and Extra-Terminal Domain Inhibitor)
BMS-986378 (Bromodomain and Extra-Terminal Domain Inhibitor)

Trial OverviewThe study tests two investigational drugs: BMS-986158 for pediatric solid tumors or lymphoma (Arm 1), and BMS-986378 for pediatric brain tumors or those that have spread to the brain (Arm 2). It aims to see if these drugs are safe and effective in treating these conditions.

Participant Groups

4Treatment groups

Experimental Treatment

Group I: Arm 2 Cohort BExperimental Treatment1 Intervention

* Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days. * Patients with relapsed or refractory CNS tumors or CNS metastatic tumors that have defined molecular features predicted to increase sensitivity to BET inhibition

Group II: Arm 2 Cohort AExperimental Treatment1 Intervention

* Patients will receive BMS-986378 (also known as CC-90010) monotherapy orally for 4 days every 28 days. * Patients with relapsed or refractory CNS tumors or CNS metastatic tumors

Group III: Arm 1 Cohort BExperimental Treatment1 Intervention

* Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles. * Patients with relapsed or refractory solid tumors or lymphoma that have defined molecular features predicted to increase sensitivity to BET inhibition

Group IV: Arm 1 Cohort AExperimental Treatment1 Intervention

* Patients will receive BMS-986158 monotherapy orally for 5 days on / 2 days off per week in 28-day cycles. * Patients with unselected relapsed or refractory solid tumors or lymphoma