A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Amgen

Status and phase: Enrolling; Phase 1

Conditions: Extensive Stage Small Cell Lung Cancer

Treatments: Drug: Tarlatamab; Drug: AB248

Study type: Interventional

Funder types: Industry

Identifiers

NCT07037758

20240200

Details and patient eligibility

About

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.

Enrollment: 380 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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 (CNS) metastases.
2. Participants with brain metastases may be eligible if criteria defined in the protocol are met.
3. Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy (including tarlatamab).
4. Prior interleukin (IL)-2, IL-7 or IL-15 targeted therapy.
5. Baseline (at rest) requirement of supplemental oxygen.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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380 participants in 2 patient groups

Dose Exploration

Experimental group

Description:

Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.

Treatment:

Drug: AB248

Drug: Tarlatamab

Dose Expansion

Experimental group

Description:

The dose expansion part will test tarlatamab in combination with the MTCD/recommended dose for expansion of AB248 identified in the dose exploration part. An optional cohort may be opened based on emerging data to study tarlatamab in combination with AB248 at a lower dose than the MTCD/recommended dose for expansion or with an alternative dose regimen at a AB248 dose lower than or equal to MTCD/recommended dose for expansion.

Treatment:

Drug: AB248

Drug: Tarlatamab