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
- Registration Number
- NCT05815160
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 78
Inclusion Criteria:<br><br> 1. Histologically or cytologically confirmed SCLC<br><br> 2. Tumor that is not bleeding<br><br> 3. Prior platinum-based chemotherapy (carboplatin and/or cisplatin)<br><br> - Part 1 (dose escalation): Recurrence or progression after a minimum of 45 days<br> since the last dose of prior standard platinum-based therapy<br><br> - Part 2 (expansion): Recurrence or progression after a minimum of 90 days since<br> the last dose of prior standard platinum-based therapy<br><br> 4. Measurable disease per RECIST 1.1<br><br> 5. Willingness and ability to undergo tumor biopsy unless an archived tumor sample is<br> available<br><br> 6. ECOG performance status of 0-1<br><br> 7. Life expectancy of at least 3 months in the best judgment of the Investigator<br><br> 8. Adequate bone marrow, hepatic and renal function, adequate coagulation status<br><br> 9. Willingness and ability to comply with scheduled visits, study treatment plans,<br> laboratory tests, and other study procedures.<br><br>Exclusion Criteria:<br><br> 1. Use of an investigational agent or medical device within 28 days prior to first dose<br> of study treatment.<br><br> 2. History of other malignancies requiring active treatment in the last 2 years prior<br> to first dose of study treatment, except for superficial bladder cancers, ductal<br> carcinoma in situ or other carcinomas in situ, and non-melanoma skin cancers (basal<br> cell/squamous cell skin cancer) that have been treated with curative intent.<br><br> 3. History of myocardial infarction or stroke in the last 6 months prior to first dose<br> of study treatment, congestive heart failure greater than New York Heart Association<br> (NYHA) class II, unstable angina pectoris, unexplained recurrent syncope, cardiac<br> arrhythmia requiring treatment, known family history of sudden death from<br> cardiac-related causes before the age of 50, or any cardiotoxicity experienced after<br> previous chemotherapy.<br><br> 4. Left ventricular ejection fraction (LVEF) below 55%.<br><br> 5. QTcF >450 ms, history of congenital long QT syndrome, or clinically significant<br> conduction abnormality, or any conduction abnormality that may increase the risk of<br> TdP.<br><br> 6. Clinically significant gastrointestinal abnormality that could affect the absorption<br> of orally administered drugs<br><br> 7. Major surgery =4 weeks prior to first dose of study treatment or incomplete recovery<br> from the surgical procedure at the time of the first dose of study treatment.<br><br> 8. Radiographic findings showing tumor involvement with large blood vessels or poor<br> demarcation from them with increased risk for bleeding.<br><br> 9. Radiographic findings of Interstitial lung disease (ILD) that are considered<br> clinically significant.<br><br> 10. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated<br> drainage.<br><br> 11. Any infection requiring the systemic use of an antibiotic or antiviral agent.<br><br> 12. Known Hepatitis C virus (HCV), Hepatitis B virus (HBV), or Human Immunodeficiency<br> Virus (HIV) infection. Participants with past infections that have been cured may be<br> enrolled.<br><br> 13. Immunization with live or live-attenuated vaccine within 28 days prior to first dose<br> of study treatment.<br><br> 14. Inability or unwillingness to swallow oral medications.<br><br> 15. Chemotherapy, monoclonal antibodies/biologics, or radiotherapy with curative intent<br> within 28 days prior to first dose of study treatment. Palliative radiation is<br> allowed up to 1 week prior to study treatment start.<br><br> 16. Unresolved AEs or toxicities due to previous treatments >Grade 1. Note: Participants<br> with =Grade 2 alopecia or endocrinopathies controlled by replacement therapy are<br> exceptions and may qualify for the study.<br><br> 17. Hypersensitivity to Debio 0123, etoposide or carboplatin, or any of the excipients<br> found in the formulations for Debio 0123, etoposide, or carboplatin. If a prior<br> hypersensitivity to carboplatin has been observed but a successful desensitization<br> was performed for the participant, he or she may be eligible for the study.<br><br> 18. Prior exposure to any WEE1 inhibitor<br><br>Note: Other inclusion/exclusion criteria mentioned in the protocol may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Part 1: Number of Participants Experiencing Dose-limiting Toxicities (DLTs);Parts 1 and 2: Number of Participants With at Least One Treatment Emergent Adverse Event (TEAE);Parts 1 and 2: Number of Participants With Clinically Significant Abnormalities in Laboratory, Vital Signs, Electrocardiogram (ECG), and Echocardiogram Parameters;Parts 1 and 2: Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS)
- Secondary Outcome Measures
Name Time Method