RECRUITING

Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

Conditions

Small Cell Lung Cancer Recurrent Small cell lung cancer (SCLC)Recurrent Debio 0123 Carboplatin Etoposide WEE1 inhibitor WEE-1 inhibitor Platinum-based therapy Platinum-based chemotherapy

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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

The primary purpose of part 1 (dose escalation) of this study is to identify the recommended dose and to characterize the safety and tolerability of Debio 0123 in combination with carboplatin and etoposide. The primary purpose of part 2 (dose expansion) of this study is to characterize the safety and tolerability of Debio 0123 at the recommended dose when administered in combination with carboplatin and etoposide.

Official Title

A Phase 1 Dose-Escalation and Expansion Study to Assess Safety and Preliminary Antitumor Activity of Debio 0123 in Combination With Carboplatin and Etoposide in Adult Participants With Small Cell Lung Cancer That Recurred or Progressed After Previous Standard Platinum-Based Therapy

Quick Facts

Study Start:2023-05-02

Study Completion:2026-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05815160

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
1. Histologically or cytologically confirmed SCLC 2. Tumor that is not bleeding 3. Prior platinum-based chemotherapy (carboplatin and/or cisplatin) * Part 1 (dose escalation): Recurrence or progression after a minimum of 45 days since the last dose of prior standard platinum-based therapy * Part 2 (expansion): Recurrence or progression after a minimum of 90 days since the last dose of prior standard platinum-based therapy 4. Measurable disease per RECIST 1.1 5. Willingness and ability to undergo tumor biopsy unless an archived tumor sample is available 6. ECOG performance status of 0-1 7. Life expectancy of at least 3 months in the best judgment of the Investigator 8. Adequate bone marrow, hepatic and renal function, adequate coagulation status 9. Willingness and ability to comply with scheduled visits, study treatment plans, laboratory tests, and other study procedures.	1. Use of an investigational agent or medical device within 28 days prior to first dose of study treatment. 2. History of other malignancies requiring active treatment in the last 2 years prior to first dose of study treatment, except for superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent. 3. History of myocardial infarction or stroke in the last 6 months prior to first dose of study treatment, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, known family history of sudden death from cardiac-related causes before the age of 50, or any cardiotoxicity experienced after previous chemotherapy. 4. Left ventricular ejection fraction (LVEF) below 55%. 5. QTcF \>450 ms, history of congenital long QT syndrome, or clinically significant conduction abnormality, or any conduction abnormality that may increase the risk of TdP. 6. Clinically significant gastrointestinal abnormality that could affect the absorption of orally administered drugs 7. Major surgery ≤4 weeks prior to first dose of study treatment or incomplete recovery from the surgical procedure at the time of the first dose of study treatment. 8. Radiographic findings showing tumor involvement with large blood vessels or poor demarcation from them with increased risk for bleeding. 9. Radiographic findings of Interstitial lung disease (ILD) that are considered clinically significant. 10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage. 11. Any infection requiring the systemic use of an antibiotic or antiviral agent. 12. Known Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Human Immunodeficiency Virus (HIV) infection. Participants with past infections that have been cured may be enrolled. 13. Immunization with live or live-attenuated vaccine within 28 days prior to first dose of study treatment. 14. Inability or unwillingness to swallow oral medications. 15. Chemotherapy, monoclonal antibodies/biologics, or radiotherapy with curative intent within 28 days prior to first dose of study treatment. Palliative radiation is allowed up to 1 week prior to study treatment start. 16. Unresolved AEs or toxicities due to previous treatments \>Grade 1. Note: Participants with ≤Grade 2 alopecia or endocrinopathies controlled by replacement therapy are exceptions and may qualify for the study. 17. Hypersensitivity to Debio 0123, etoposide or carboplatin, or any of the excipients found in the formulations for Debio 0123, etoposide, or carboplatin. If a prior hypersensitivity to carboplatin has been observed but a successful desensitization was performed for the participant, he or she may be eligible for the study. 18. Prior exposure to any WEE1 inhibitor

Inclusion Criteria

Exclusion Criteria

1. Histologically or cytologically confirmed SCLC
2. Tumor that is not bleeding
3. Prior platinum-based chemotherapy (carboplatin and/or cisplatin)
* Part 1 (dose escalation): Recurrence or progression after a minimum of 45 days since the last dose of prior standard platinum-based therapy
* Part 2 (expansion): Recurrence or progression after a minimum of 90 days since the last dose of prior standard platinum-based therapy
4. Measurable disease per RECIST 1.1
5. Willingness and ability to undergo tumor biopsy unless an archived tumor sample is available
6. ECOG performance status of 0-1
7. Life expectancy of at least 3 months in the best judgment of the Investigator
8. Adequate bone marrow, hepatic and renal function, adequate coagulation status
9. Willingness and ability to comply with scheduled visits, study treatment plans, laboratory tests, and other study procedures.

1. Use of an investigational agent or medical device within 28 days prior to first dose of study treatment.
2. History of other malignancies requiring active treatment in the last 2 years prior to first dose of study treatment, except for superficial bladder cancers, ductal carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal cell/squamous cell skin cancer) that have been treated with curative intent.
3. History of myocardial infarction or stroke in the last 6 months prior to first dose of study treatment, congestive heart failure greater than New York Heart Association (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac arrhythmia requiring treatment, known family history of sudden death from cardiac-related causes before the age of 50, or any cardiotoxicity experienced after previous chemotherapy.
4. Left ventricular ejection fraction (LVEF) below 55%.
5. QTcF \>450 ms, history of congenital long QT syndrome, or clinically significant conduction abnormality, or any conduction abnormality that may increase the risk of TdP.
6. Clinically significant gastrointestinal abnormality that could affect the absorption of orally administered drugs
7. Major surgery ≤4 weeks prior to first dose of study treatment or incomplete recovery from the surgical procedure at the time of the first dose of study treatment.
8. Radiographic findings showing tumor involvement with large blood vessels or poor demarcation from them with increased risk for bleeding.
9. Radiographic findings of Interstitial lung disease (ILD) that are considered clinically significant.
10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
11. Any infection requiring the systemic use of an antibiotic or antiviral agent.
12. Known Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Human Immunodeficiency Virus (HIV) infection. Participants with past infections that have been cured may be enrolled.
13. Immunization with live or live-attenuated vaccine within 28 days prior to first dose of study treatment.
14. Inability or unwillingness to swallow oral medications.
15. Chemotherapy, monoclonal antibodies/biologics, or radiotherapy with curative intent within 28 days prior to first dose of study treatment. Palliative radiation is allowed up to 1 week prior to study treatment start.
16. Unresolved AEs or toxicities due to previous treatments \>Grade 1. Note: Participants with ≤Grade 2 alopecia or endocrinopathies controlled by replacement therapy are exceptions and may qualify for the study.
17. Hypersensitivity to Debio 0123, etoposide or carboplatin, or any of the excipients found in the formulations for Debio 0123, etoposide, or carboplatin. If a prior hypersensitivity to carboplatin has been observed but a successful desensitization was performed for the participant, he or she may be eligible for the study.
18. Prior exposure to any WEE1 inhibitor

Contacts and Locations

Study Contact

Debiopharm International S.A

CONTACT

+41 21 321 01 11

clinicaltrials@debiopharm.com

Study Locations (Sites)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

United States

Henry Ford Health System

Detroit, Michigan, 48202

United States

Roswell Park Comprehensive Cancer Center

Buffalo, New York, 14263

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 Date2023-05-02

Study Completion Date2026-04

Study Record Updates

Study Start Date2023-05-02

Study Completion Date2026-04

Terms related to this study

Keywords Provided by Researchers

Small cell lung cancer (SCLC)
Recurrent
Debio 0123
Carboplatin
Etoposide
WEE1 inhibitor
WEE-1 inhibitor
Platinum-based therapy
Platinum-based chemotherapy

Additional Relevant MeSH Terms

Small Cell Lung Cancer Recurrent