A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
NCT ID: NCT07037758
Last Updated: 2025-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
380 participants
INTERVENTIONAL
2025-09-16
2031-01-18
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Exploration
Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.
Tarlatamab
Administered as an IV infusion.
AB248
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
Dose Expansion
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.
Tarlatamab
Administered as an IV infusion.
AB248
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
Interventions
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Tarlatamab
Administered as an IV infusion.
AB248
Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
90 Years
ALL
No
Sponsors
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Asher Biotherapeutics, Inc.
INDUSTRY
Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Emory University
Atlanta, Georgia, United States
Norton Cancer Institute - Downtown
Louisville, Kentucky, United States
Siteman Cancer Center
St Louis, Missouri, United States
Sidney Kimmel Cancer Center
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Baptist Cancer Center
Memphis, Tennessee, United States
Chungbuk National University Hospital
Cheongju Chungbuk, , South Korea
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, , Turkey (Türkiye)
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, , Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, , Turkey (Türkiye)
Countries
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Central Contacts
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Related Links
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AmgenTrials clinical trials website
Other Identifiers
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20240200
Identifier Type: -
Identifier Source: org_study_id
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