A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
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)
Sponsor: Amgen + Asher Biotherapeutics, Inc.
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 2.5 years
Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)
Time frame: Up to 35 days
Secondary Endpoints
Maximum Serum Concentration (Cmax) of Tarlatamab
Minimum Serum Concentration (Cmin) of Tarlatamab
Area Under the Concentration-time Curve (AUC) of Tarlatamab
Eligibility 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 adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver). 6. Participants must submit a fresh tumor biopsy at screening unless a new biopsy cannot be performed safely or is infeasible. Participants who cannot provide fresh tissue may provide archival tissue that was collected after last anticancer therapy. Exclusion Criteria: 1. Symptomatic central nervous system (…
Read full criteria on CT.gov →✦ Analyst Commentary
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