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
NCT Number: NCT06480552
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Advanced Solid Tumors
Interventions: DRUG: TEV-56278|DRUG: Pembrolizumab
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-22
Completion Date: 2031-02-25
Locations: Teva Investigational Site 12014, Huntersville, North Carolina, 28078, United States

Summary:
The primary objectives of this trial are to:

* Characterize the safety and tolerability of TEV-56278
* Determine the Recommended Phase 2 Dose (RP2D)
* Evaluate antitumor activity of TEV-56278
* Determine the safety and tolerability of TEV-56278 in combination with pembrolizumab
* Determine a RP2D of TEV-56278 in combination with pembrolizumab

The secondary objectives of this trial are to:

* Characterize the serum pharmacokinetics of TEV-56278
* Evaluate the antitumor activity of TEV-56278
* Determine the safety and tolerability of TEV-56278
* Evaluate other measures of antitumor activity of TEV-56278
* Evaluate anti-tumor activity

Participants will be treated up to 12 months with a follow-up period of up to 12 months after last infusion. The total duration of the trial will be up to 25 months for individual participants.

Primary Outcome Measures: Incidence of AEs with CTCAE Grade≥3 in the escalation phase, CTCAE: Common Terminology Criteria for Adverse Events, Up to 15 months after 1st infusion in the escalation phase|Incidence of SAEs in the escalation phase, Up to 15 months after 1st infusion in the escalation phase|Incidence of AEs meeting protocol-defined DLT criteria in the escalation phase, DLT: dose-limiting toxicity, Up to 28 days after 1st infusion in the escalation phase|Incidence of dose modifications due to AEs in the escalation phase, Up to 12 months after 1st infusion in the escalation phase|Incidence of AEs leading to discontinuation in the escalation phase, Up to 12 months after 1st infusion in the escalation phase|Recommended Phase 2 dose as monotherapy, Up to 24 months after 1st infusion|Objective Response Rate (ORR) based on RECIST criteria in the expansion phase, RECIST: Response Evaluation Criteria in Solid Tumors., Up to 24 months after the 1st dose in the expansion phase|Duration of Response (DOR) in the expansion phase, Up to 24 months after the 1st dose in the expansion phase|Recommended Phase 2 dose in combination with Pembrolizumab, Up to 24 months after 1st dose|Incidence of AEs with CTCAE Grade≥3 in the combination phase, Up to 15 months after 1st infusion in the combination phase|Incidence of SAEs in the combination phase, Up to 15 months after 1st infusion in the combination phase|Incidence of AEs meeting protocol-defined DLT criteria in the combination phase, Up to 28 days after 1st infusion in the combination phase|Incidence of dose modifications due to AEs in the combination phase, Up to 12 months after 1st infusion in the combination phase|Incidence of AEs leading to discontinuation in the combination phase, Up to 12 months after 1st infusion in the combination phase
Secondary Outcome Measures: AUC0-last, Area under the serum concentration-time curve from time 0 to last measurable drug concentration, Predose up to Day 8|Cmax, Maximum observed concentration, Predose up to Day 8|tmax, Time to maximum observed drug concentration, Predose up to Day 8|Objective Response Rate (ORR) based on RECIST criteria in the escalation phase, Up to 24 months after 1st infusion in the escalation phase|Incidence of AEs with CTCAE Grade≥3 in the expansion phase, Up to 24 months after 1st infusion in the expansion phase|Incidence of SAEs in the expansion phase, Up to 15 months after 1st infusion in the expansion phase|Incidence of dose modifications due to AEs in the expansion phase, Up to 12 months after 1st infusion in the expansion phase|Incidence of AEs leading to discontinuation in the expansion phase, Up to 12 months after 1st infusion in the expansion phase|Disease Control Rate (DCR) according to RECIST (v1.1) criteria, Up to 24 months after 1st infusion|Time to Respond (TTR) according to RECIST (v1.1) criteria, Up to 24 months after 1st infusion|Objective Response Rate (ORR) based on RECIST criteria in the combination phase, Up to 24 months after 1st infusion in the combination phase