Recruiting
Sponsor ID
20250114
Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)DeLLphi-313
Study Details
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.
Protocol Summary
Primary Outcome Measures
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Timeframe: Up to 3.5 years
Parts 1 and 3: Number of Participants Experiencing Dose-limiting Toxicities (DLTs)
Timeframe: Up to Day 21
Secondary Outcome Measures
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Timeframe: Up to 3.5 years
Duration of Response (DOR) per RECIST v1.1
Timeframe: Up to 3.5 years
Time to Response (TTR) per RECIST v1.1
Timeframe: Up to 3.5 years
Disease Control Rate (DCR) per RECIST v1.1
Timeframe: Up to 3.5 years
Progression-free Survival (PFS) per RECIST v1.1
Timeframe: Up to 3.5 years
Time to Progression (TTP) per RECIST v1.1
Timeframe: Up to 3.5 years
Time to Subsequent Therapy
Timeframe: Up to 3.5 years
Overall survival (OS)
Timeframe: Up to 3.5 years
Serum Tarlatamab Concentrations
Timeframe: Up to Week 36
Locations
Location
Baptist Cancer Center
Memphis, TN, United States, 38120
Status
Recruiting
Location
New York University Cancer Institute
New York, NY, United States, 10016
Status
Recruiting
Location
Next Virginia
Fairfax, VA, United States, 22031
Status
Recruiting
Location
Izmir Ekonomi Universitesi Medical Point Hastanesi
Izmir, Turkey, 35575
Status
Recruiting
Location
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey, 06230
Status
Recruiting
Location
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, Turkey, 01370
Status
Recruiting
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