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

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

Status
Active
Cancer Type
Lung Cancer
Neuroendocrine Tumor
Unknown Primary
Trial Phase
Phase I
Eligibility
18 - 90 Years, Male and Female
Study Type
Treatment
NCT ID
NCT07037758
Protocol IDs
20240200 (primary)
NCI-2025-06049
Study Sponsor
Amgen, Inc.

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

  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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.