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

NCT07037758
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Phase
Phase 1
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Recruitment status
Recruiting
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Participants
380
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Lead sponsor
Amgen
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Start date
2025-09-16
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Number of sites
19
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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.
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Acronym
DeLLphi-311
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Short title
A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
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Official title
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)
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2031-01-18
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First posted
2025-06-25
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Registry last updated
2026-05-29
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Primary completion date
2028-03-18
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Start date
2025-09-16
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Participants
380
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Participant count basis
Estimated
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Planned participants
380
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Protocol amendments
0
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Number of sites
19
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07037758
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ClinicalTrials.gov ID
NCT07037758
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Registry record
Open registry record
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Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Number of Participants with Treatment-emergent Adverse Events (TEAEs)

    Timeframe: Up to 2.5 years

    Clinically significant changes in vital signs and clinical laboratory tests will be reported as adverse events.

  2. Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)

    Timeframe: Up to 35 days

  1. Maximum Serum Concentration (Cmax) of Tarlatamab

    Timeframe: Up to approximately 21 weeks

  2. Minimum Serum Concentration (Cmin) of Tarlatamab

    Timeframe: Up to approximately 21 weeks

  3. Area Under the Concentration-time Curve (AUC) of Tarlatamab

    Timeframe: Up to approximately 21 weeks

  4. Half-life (t1/2) of Tarlatamab

    Timeframe: Up to approximately 21 weeks

  5. Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Timeframe: Up to 2.5 years

  6. Duration of Response (DOR) per RECIST 1.1

    Timeframe: Up to 2.5 years

  7. Time to Response (TTR) per RECIST 1.1

    Timeframe: Up to 2.5 years

  8. Disease Control (DC) per RECIST 1.1

    Timeframe: Up to 2.5 years

  9. Progression-free Survival (PFS) per RECIST 1.1

    Timeframe: Up to 2.5 years

  10. Time to Progression (TTP) per RECIST 1.1

    Timeframe: Up to 2.5 years

  11. Time to Subsequent Therapy

    Timeframe: Up to 2.5 years

  12. Overall Survival (OS)

    Timeframe: Up to 2.5 years

  13. Number of Participants with Anti-AB248 Antibody Formation

    Timeframe: Up to 2.5 years

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
90 Years
Healthy volunteers
No

  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.

  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.
Sources for eligibility
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  • Banner MD Anderson Cancer CenterGilbert, United StatesRecruiting
  • University of Southern California, Norris Comprehensive Cancer CenterLos Angeles, United StatesRecruiting
  • Moffitt Cancer CenterTampa, United StatesRecruiting
  • Emory UniversityAtlanta, United StatesRecruiting
  • Norton Cancer Institute - DowntownLouisville, United StatesRecruiting
  • Dana-Farber Cancer InstituteBoston, United StatesRecruiting
  • Siteman Cancer CenterSt Louis, United StatesRecruiting
  • Memorial Sloan Kettering Cancer CenterNew York, United StatesRecruiting
  • Sidney Kimmel Cancer CenterPhiladelphia, United StatesRecruiting
  • Allegheny General HospitalPittsburgh, United StatesRecruiting
  • Avera Cancer InstituteSioux Falls, United StatesRecruiting
  • Baptist Cancer CenterMemphis, United StatesRecruiting
  • Swedish Cancer Institute Medical OncologySeattle, United StatesRecruiting
  • Chungbuk National University HospitalCheongju Chungbuk, South KoreaRecruiting
  • Seoul National University Bundang HospitalSeongnam-si, Gyeonggi-do, South KoreaRecruiting
  • Severance Hospital Yonsei University Health SystemSeoul, South KoreaRecruiting
  • Adana Sehir Egitim ve Arastirma HastanesiAdana, Turkey (Türkiye)Recruiting
  • Hacettepe Universitesi Tip Fakultesi HastanesiAnkara, Turkey (Türkiye)Recruiting
  • Ankara Bilkent Sehir HastanesiAnkara, Turkey (Türkiye)Recruiting
Sources for sites
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Sources for references
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Related records

Drugs (2)

Collaborators (1)

Lead sponsors (1)

Targets (4)