An Open-label Dose Escalation/Expansion Trial to Evaluate the Safety and Anti-tumor Activity of TEV-56278 Alone or in Combination With Pembrolizumab in Participants With Advanced or Metastatic Solid Tumors
- Conditions
- Advanced Solid Tumors
- Registration Number
- NCT06480552
- Lead Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Have an established histological diagnosis of selected solid tumor and must have<br> received and progressed on established standard therapies or have been intolerant to<br> such therapy or have been considered by the Investigator as ineligible for approved<br> standard therapy<br><br> - Have a life expectancy=12 weeks at the time of the screening<br><br> - Women of childbearing potential must agree to use highly effective methods of<br> contraception for the course of the trial through 120 days after the last dose of<br> trial medication<br><br> - Males who are sexually active with women of childbearing potential must agree to use<br> condoms and refrain from donating sperm for the course of the trial through 120 days<br> after the last dose of trial medication<br><br>NOTE- Additional criteria apply, please contact the investigator for more information<br><br>Exclusion Criteria:<br><br> - Has a history of systemic treatment therapy for cancer (including chemotherapy,<br> immunotherapy, radiotherapy, or other investigational drug) or surgery within 4<br> weeks prior to baseline<br><br> - Is currently receiving or has received hematopoietic colony-stimulating growth<br> factors within 2 weeks before screening or transfusion support 4 weeks prior to<br> screening<br><br> - Has a diagnosis of immunodeficiency<br><br> - Has active known autoimmune disease.<br><br> - Has a history of or known active brain metastases and/or carcinomatous meningitis<br> and/or leptomeningeal metastasis<br><br> - Has active or uncontrolled serious infections requiring systemic therapy within 14<br> days prior to baseline<br><br> - Has a history of clinically significant cardiovascular or cerebrovascular disease in<br> previous 6 months prior to screening<br><br> - Has evidence of clinically significant interstitial lung disease or active,<br> noninfectious pneumonitis<br><br> - Has a seizure disorder requiring therapy (such as steroids or antiepileptics)<br><br>NOTE- Additional criteria apply, please contact the investigator for more information
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of AEs with CTCAE Grade=3 in the escalation phase;Incidence of SAEs in the escalation phase;Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase;Incidence of dose modifications due to AEs in the escalation phase;Incidence of AEs leading to discontinuation in the escalation phase;Recommended Phase 2 dose as monotherapy;Objective Response Rate (ORR) based on RECIST criteria in the expansion phase;Duration of Response (DOR) in the expansion phase;Recommended Phase 2 dose in combination with Pembrolizumab;Incidence of AEs with CTCAE Grade=3 in the combination phase;Incidence of SAEs in the combination phase;Incidence of AEs meeting protocol-defined DLT criteria in the combination phase;Incidence of dose modifications due to AEs in the combination phase;Incidence of AEs leading to discontinuation in the combination phase
- Secondary Outcome Measures
Name Time Method AUC0-last;Cmax;tmax;Objective Response Rate (ORR) based on RECIST criteria in the escalation phase;Incidence of AEs with CTCAE Grade=3 in the expansion phase;Incidence of SAEs in the expansion phase;Incidence of dose modifications due to AEs in the expansion phase;Incidence of AEs leading to discontinuation in the expansion phase;Disease Control Rate (DCR) according to RECIST (v1.1) criteria;Time to Respond (TTR) according to RECIST (v1.1) criteria;Objective Response Rate (ORR) based on RECIST criteria in the combination phase