ACTIVE_NOT_RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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 in each study arm and overall when administered as monotherapy at the MTD/RP2D determined during the Dose Escalation Part 1 and to evaluate the preliminary anti-tumor activity of Debio 0123 when administered as monotherapy to participants in each study arm.

Official Title

A Phase 1, 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

Quick Facts

Study Start:2021-11-05

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05109975

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 with cyclin E1 driven selection. 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 solid tumor with biomarker-driven selection. * 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.	* 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 before the age of 50, 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).

Inclusion Criteria

Exclusion 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 with cyclin E1 driven selection. 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 solid tumor with biomarker-driven selection.
* 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.

* 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 before the age of 50, 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).

Contacts and Locations

Study Locations (Sites)

South Texas Accelerated Research Therapeutics (START) Midwest

Grand Rapids, Michigan, 49546

United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, 10021

United States

South Texas Accelerated Research Therapeutics (START)

San Antonio, Texas, 78229

United States

Froedtert Hospital and the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Debiopharm International SA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-05

Study Completion Date2027-06

Study Record Updates

Study Start Date2021-11-05

Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

Advanced Solid Tumors
WEE1-inhibitor

Additional Relevant MeSH Terms

Advanced Solid Tumors