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Recruiting NCT07037758

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

Phase I Interventional Extensive Stage Small Cell Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tarlatamab, AB248.
Who it may be relevant to
Registry conditions: Extensive Stage Small Cell Lung Cancer. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, South Korea, Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Drug Tarlatamab
    Administered as an IV infusion.
  • Drug AB248
    Administered either as an IV infusion followed by a flush or using a syringe pump without a flush.

Primary outcome measures

  • 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 outcome measures (12)
  • Maximum Serum Concentration (Cmax) of Tarlatamab [Time frame: Up to approximately 21 weeks]
  • Minimum Serum Concentration (Cmin) of Tarlatamab [Time frame: Up to approximately 21 weeks]
  • Area Under the Concentration-time Curve (AUC) of Tarlatamab [Time frame: Up to approximately 21 weeks]
  • Half-life (t1/2) of Tarlatamab [Time frame: Up to approximately 21 weeks]
  • Objective Response (OR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 [Time frame: Up to 2.5 years]
  • Duration of Response (DOR) per RECIST 1.1 [Time frame: Up to 2.5 years]
  • Time to Response (TTR) per RECIST 1.1 [Time frame: Up to 2.5 years]
  • Disease Control (DC) per RECIST 1.1 [Time frame: Up to 2.5 years]
  • Progression-free Survival (PFS) per RECIST 1.1 [Time frame: Up to 2.5 years]
  • Time to Progression (TTP) per RECIST 1.1 [Time frame: Up to 2.5 years]
  • Time to Subsequent Therapy [Time frame: Up to 2.5 years]
  • Overall Survival (OS) [Time frame: Up to 2.5 years]

Eligibility criteria

Inclusion criteria

  • Participant has provided informed consent before initiation of any study-specific activities/procedures.
  • Participants ≥ 18 years (or ≥ legal age within the country if it is older than 18 years) at the time of signing the informed consent.
  • 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.
  • Participants must have at least 1 measurable lesion as defined by RECIST 1.1 within 21-day screening period, not previously irradiated.
  • Participants must have adequate organ function (hematological, coagulation, cardiac, pulmonary, kidney, and liver).
  • 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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 13 centers
  • Banner MD Anderson Cancer Center — Gilbert
  • University of Southern California, Norris Comprehensive Cancer Center — Los Angeles
  • Moffitt Cancer Center — Tampa
  • Emory University — Atlanta
  • Norton Cancer Institute - Downtown — Louisville
  • Dana-Farber Cancer Institute — Boston
  • Siteman Cancer Center — St Louis
  • Memorial Sloan Kettering Cancer Center — New York
  • … and 5 more centers
South Korea · 3 centers
  • Chungbuk National University Hospital — Cheongju Chungbuk
  • Seoul National University Bundang Hospital — Seongnam-si, Gyeonggi-do
  • Severance Hospital Yonsei University Health System — Seoul
Turkey (Türkiye) · 3 centers
  • Adana Sehir Egitim ve Arastirma Hastanesi — Adana
  • Hacettepe Universitesi Tip Fakultesi Hastanesi — Ankara
  • Ankara Bilkent Sehir Hastanesi — Ankara

Identifiers

NCT: NCT07037758 · 20240200

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗