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
Amgen
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.
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. * Participants with Histologically or cytologically confirmed SCLC: * For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. * For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1. * For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no pri…
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.
Locations (3)
- New York University Cancer InstituteNew York, New York
- Baptist Cancer CenterMemphis, Tennessee
- Next VirginiaFairfax, Virginia