A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With ZL-1310 With or Without Anti-PD-L1 in Participants With Small Cell Lung Cancer
Summary
The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.
Arms & interventions
- DrugZL-1310
ZL-1310 will be administered as an IV infusion.
- DrugTarlatamab
Tarlatamab will be administered as an IV infusion.
- DrugDurvalumab
Durvalumab will be administered as an IV infusion.
Outcome measures
Primary
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Time frame: Up to Day 21
Secondary
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Time frame: Up to 3.5 years
Disease Control Rate (DCR) per RECIST v1.1
Time frame: Up to 3.5 years
Progression-free Survival (PFS) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Progression (TTP) per RECIST v1.1
Time frame: Up to 3.5 years
Time to Subsequent Therapy
Time frame: Up to 3.5 years
Overall survival (OS)
Time frame: Up to 3.5 years
Serum Tarlatamab Concentrations
Time frame: Up to Week 36
Eligibility criteria
Study locations (3)
New York University Cancer Institute
New York, New York, 10016
Baptist Cancer Center
Memphis, Tennessee, 38120
Next Virginia
Fairfax, Virginia, 22031