A Phase l, Dose-finding Study of Debio 0123 as Monotherapy in Adult Patients With Advanced Solid Tumors, Followed by an Expansion Part to Assess Safety and Preliminary Anti-tumor Activity

Study Identifier:
DEBIO-0123-102
CT.gov Identifier:
NCT05109975
EudraCT Identifier:
202350000000
EU Trial (CTIS) Number:
2023-504824-24-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

To evaluate 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

To evaluate 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.

To present the design of a phase 1 study of continuous Debio 0123 administered as a single agent in pts with advanced solid tumors.

Pharmacodynamic biomarkers will be correlated with tumor response and/or PK. The dose-expansion part may start after MTD and/or RP2D determination.

To evaluate Debio 0123 monotherapy in patients with advanced solid tumors who have recurred or progressed following prior therapy and/or without available standard therapy.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18 - 64 Years
    Study Drug
  • Drug: Experimental: Part 1: Dose Escalation
    • Read More
  • Drug: Experimental: Part 2: Expansion
  • Drug: ASCO 2024:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    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 disease for which no available standard therapy of proven benefit.
    • Part 2 expansion only:
    • Measurable disease per RECIST version 1.1 criteria for each arm.
    • Participants (≥18 years old) who progressed or have recurrence of one of the tumor types specified in the study arms following standard therapy according to RECIST version 1.1, or for whom, in the opinion of the Investigator, no effective standard therapy exists.
    • Arm A: Histologically or cytologically confirmed USC that recurred or progressed following at least 1 prior platinum-based line of therapy for management of advanced or metastatic disease.
    • Arm B: Histologically or cytologically confirmed, recurrent, high-grade EOC, primary peritoneal cancer, or fallopian tube cancer. Participants must have progressed after at least 1 prior platinum-based therapy for advanced/metastatic disease.
    • Arm C: Histologically or cytologically confirmed, locally advanced or metastatic, specific solid tumors.
    • 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) 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.
    • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
    • Key inclusion criteria are histologically or cytologically confirmed locally advanced or metastatic solid tumors, and ECOG-PS 0 or 1.
    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.
    • Any anti-cancer treatment, monoclonal antibodies/biologics, investigational treatment, 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. Exceptions will be made for Grade 2 anemia (if hemoglobin is not less than 9 g/dL or 5.6 mmol/L) and >Grade 2 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.]
    • Key exclusion criteria are asymptomatic or unstable brain metastases, history of cardiac disorders, inability to swallow oral medication or abnormalities affecting drug absorption.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Kyriakos Papadopoulos
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Manish Sharma
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor