A Phase 1b Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Amgen

Summary

The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248. The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.

Eligibility

Age range: 18–90 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: 1. Participant has provided informed consent before initiation of any study-specific activities/procedures. 2. Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent. 3. Participants with histologically or cytologically confirmed ES-SCLC that has progressed or recurred following at least 1 line of anti-cancer therapy for ES-SCLC. 4. Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated. 5. Participants must have adeq…

Interventions

Drug
Tarlatamab
Administered as an IV infusion.
Drug
AB248
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Locations (19)

Banner MD Anderson Cancer Center
Gilbert, Arizona
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California
Moffitt Cancer Center
Tampa, Florida
Emory University
Atlanta, Georgia
Norton Cancer Institute - Downtown
Louisville, Kentucky
Dana-Farber Cancer Institute
Boston, Massachusetts