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NCT07037758PHASE1RECRUITING

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

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Key Facts

Study type
INTERVENTIONAL
Conditions
Extensive Stage Small Cell Lung Cancer
Interventions
Tarlatamab, AB248
Enrollment
380 participants
Primary completion
Mar 2028
Study completion
Jan 2031
First posted
Jun 2025
Last updated
May 2026

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

Expert commentary on why this trial matters and what to watch for.

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Source

Open on ClinicalTrials.gov