Phase 1 Study of the Dual MDM2/MDMX Inhibitor ALRN-6924 in Pediatric Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Overseen byDavid S Shulman, MD

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?

This research study is studying a novel drug called ALRN-6924 as a possible treatment for resistant (refractory) solid tumor, brain tumor, lymphoma or leukemia. The drugs involved in this study are: * ALRN-6924 * Cytarabine (for patients with leukemia only)

Eligibility Criteria

Inclusion Criteria

You have a solid tumor or lymphoma that has been confirmed by a tissue biopsy or surgery. The only exception is for those with retinoblastoma.

You have a disease that has come back or hasn't responded to standard treatments anymore.

You have a specific type of cancer that involves extra copies of the MDM2 gene and a normal TP53 gene.

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Exclusion Criteria

Patients receiving medications within 48 hours of enrollment that are primarily cleared by organic anion transporter polypeptide [OATP] members OATP1B1 and OATP1B3

You or your family has a history of swelling, particularly around the face, throat, or airways.

You are currently breastfeeding.

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Treatment Details

Interventions

ALRN-6924 (MDM2/MDMX Inhibitor)
Cytarabine (Anti-metabolites)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: ALRN-6924 -- Cohort CExperimental Treatment2 Interventions

* Patients will receive ALRN-6924 in combination with cytarabine on days 1, 8 (± 1 day), and 15 (± 1 day) of a 28-day cycle. * Cytarabine is administered intravenously. * ALRN-6924 will be administered intravenously. * Participants with TP53 wild type acute leukemia will participate in this cohort.

Group II: ALRN-6924 -- Cohort BExperimental Treatment1 Intervention

* Participants will receive ALRN-6924 monotherapy on days 1, 4 (± 1 day), 8 (± 1 day), and 11 (± 1 day) of a 21-day cycle. * ALRN-6924 will be administered intravenously. * Participants with solid and CNS tumors and lymphoma with specific diagnoses or molecular features will participate in this cohort.

Group III: ALRN-6924 -- Cohort AExperimental Treatment1 Intervention

* Participants will receive ALRN-6924 monotherapy on days 1, 4 (± 1 day), 8 (± 1 day), and 11 (± 1 day) of a 21-day cycle. * ALRN-6924 will be administered intravenously. * Participants with otherwise unselected TP53 wild type solid tumors and lymphoma will participate in this cohort.