RightFit
RecruitingPhase 1

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

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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of tarlatamab given with AB248 and how well people tolerate them together. It also aims to find a dose of AB248 to use with tarlatamab. It is for adults with small cell lung cancer that has spread widely and has grown or come back after at least one cancer treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Agree to join the study before any study tests or procedures begin.
  • Be at least 18, or the legal adult age in your country if it is older.
  • Have small cell lung cancer that has spread widely, confirmed by tissue or cell tests, and has grown or returned after at least one treatment.
  • Have at least one tumor that can be measured during the 21-day screening period and has not been treated with radiation.
  • Have blood counts, blood clotting, heart, lungs, kidneys, and liver that work well enough for the study.
  • Provide a new tumor tissue sample during screening. If this is unsafe or not possible, you may provide a stored sample collected after your last cancer treatment.

Who can't join

  • Have cancer that has spread to the brain or spinal cord and causes symptoms. Some people with cancer in the brain may join if they meet the study's rules.
  • Have had treatment targeting DLL3, a protein, including tarlatamab.
  • Have had treatment targeting IL-2, IL-7, or IL-15, proteins involved in the immune system.
  • Need extra oxygen while resting.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (13)

AZ

CA

FL

GA

KY

MA

MO

NY

PA

SD

TN

WA