A Study to Evaluate Safety and Preliminary Anti-tumor Activity of Debio 0123 as Monotherapy in Adult Participants With Advanced Solid Tumors

• Status: Not yet recruiting
• Trial end date: 2025-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study has two parts: Part 1 and Part 2. The purpose of this study in Part 1, Dose Escalation Part is to determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of Debio 0123 as monotherapy with repeated dosing in adults with advanced solid tumors that recurred or progressed after prior therapy and/or for whom no standard therapy of proven benefit is available.

The purpose in Part 2, Expansion Part of this study, is to characterize the safety and tolerability of Debio 0123 when administered as monotherapy at the RP2D determined during the Dose Escalation Part 1 and to evaluate the preliminary anti-tumor activity of Debio 0123 when administered as monotherapy in participants with specific solid tumor types that recurred or progressed following prior lines of therapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Debiopharm International SA

Criteria

Inclusion Criteria:

• Part 1 dose escalation only

• Histologically or cytologically confirmed locally advanced or metastatic solid tumors.

• Measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.

• Disease progression under or following standard therapy and/or no available standard therapy of proven benefit.

• Part 2 expansion only

o Measurable disease per RECIST version 1.1 criteria

• Part 1 dose escalation and Part 2 expansion

• Accessible tumor for biopsy, and participant willing to undergo tumor biopsy unless archived tumor sample is available.

• Eastern Cooperative Oncology Group (ECOG) performance status (PS) PS 0-1.

• Life expectancy of at least 3 months, in the best judgment of the Investigator.

• Adequate bone marrow, liver biochemistry, renal function, and coagulation status.

• Willing to practice highly effective methods of contraception.

Exclusion Criteria:

• Participants with active second malignancies requiring therapy in the last 6 months, with the exception of superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated surgically.

• Current use of an investigational agent or a medical device.

• Major surgery ≤4 weeks prior to the first dose of study treatment or who have not recovered from the surgical procedure.

• Brain tumors and/or brain metastases unless they are asymptomatic, stable on recent imaging (not dated more than 28 days from the inclusion date), and have not required active treatment in the last month before study entry.

• History of myocardial infarction or stroke within 6 months, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, family history of sudden death from cardiac-related causes, or any cardiotoxicity experienced after previous chemotherapy.

• Known infection requiring systemic use of an antibiotic or antiviral agent.

• Immunization with live or live-attenuated vaccine within 28 days prior to study inclusion or planned injection of live or live-attenuated vaccines.

• Pregnancy or breast-feeding.

• Inability or unwillingness to swallow oral medication.

• Clinically significant gastrointestinal abnormality that would affect the absorption of the drug.

• Chemotherapy, monoclonal antibodies/biologics, or radiotherapy with curative intent within 28 days prior to starting study treatment. Palliative radiation for pain relief is allowed up to 1 week prior to starting study treatment.

• Unresolved AEs or toxicities due to previous treatments, i.e., >Grade 1 or >Grade 2 for alopecia and endocrinopathies controlled by replacement therapy (example, hypothyroidism due to immune checkpoint inhibitors)

[Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.]