Study of Oral Debio 0123 in Combination With Carboplatin in Participants With Advanced Solid Tumors

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Debiopharm International SA

No Placebo Group

Trial Summary

What is the purpose of this trial?

This study has two parts: Dose Escalation and Dose Expansion. The primary objective of the study, in the Dose Escalation Part is to determine the recommended phase 2 dose (RP2D) of Debio 0123 when administered in combination with carboplatin in participants with advanced solid tumors that recurred or progressed after prior cisplatin or carboplatin containing therapy and for which no standard therapy of proven benefit is available. The primary objective of the study, in the Dose Expansion Part is to characterize the safety and tolerability of Debio 0123 when administered in combination with carboplatin at the RP2D determined during the dose escalation part of the study and to evaluate the preliminary antitumor activity of Debio 0123 when administered in combination with carboplatin.

Research Team

Eligibility Criteria

Inclusion Criteria

ECOG PS 0-1

Your Eastern Cooperative Oncology Group performance score is between 0 and 1.

You have a prognosis of lasting at least 3 months.

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Treatment Details

Interventions

Carboplatin (Alkylating Agent)
Debio 0123 (Histone Deacetylase Inhibitor)

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Dose Expansion: Debio 0123Experimental Treatment2 Interventions

Participants with platinum-resistant selected solid tumors will receive Debio 0123, orally, daily, depending on the RP2D determined in the previous part, for 3 or 6 days during each cycle in combination with carboplatin IV infusion.

Group II: Dose Escalation: Group B: Debio 0123Experimental Treatment2 Interventions

Participants will receive Debio 0123, orally, daily, for 6 days during each cycle in combination with carboplatin IV infusion.

Group III: Dose Escalation: Group A: Debio 0123Experimental Treatment2 Interventions

Participants will receive Debio 0123 as monotherapy (Day -3), orally, daily for 3 days during Cycle 1 then in combination with carboplatin intravenous infusion from Cycle 2 onwards. Depending on pharmacokinetics (PK) and safety results from previous cohorts, the Debio 0123 dosing regimen may be modified for subsequent cohorts.

Carboplatin is already approved in Canada for the following indications: