Tarlatamab + AB248 for Small Cell Lung Cancer

(DeLLphi-311 Trial)

Recruiting at 6 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Disqualifiers: Symptomatic CNS metastases, Prior DLL3 therapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

380 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment combination for small cell lung cancer that has returned or worsened after at least one prior treatment. Researchers aim to determine the safest dose of two drugs, tarlatamab and AB248, when used together, and to assess patient tolerance. The trial consists of two parts: one to explore different doses and another to test the optimal dose identified. It seeks participants whose cancer has returned and who have at least one measurable tumor that can be tracked during the study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the combination of tarlatamab and AB248 is under study to assess its safety and tolerability. As this study is in the early stages, researchers focus on determining the right dose that can be taken without serious side effects.

In other studies, tarlatamab has been tested with different drugs and found to be generally safe, with manageable side effects. However, its use with AB248 is new, so specific safety details are still being determined.

For those considering joining this trial, it's important to know that early trials are designed to closely monitor participants' reactions to the treatment. This approach helps ensure safety and identify the best dose. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard of care for small cell lung cancer, which often includes chemotherapy and radiation, the combination of Tarlatamab and AB248 offers a novel approach. Tarlatamab is a bispecific T-cell engager that targets cancer cells, potentially improving the immune system's ability to fight the cancer. AB248 acts as an enhancer, which could boost the effectiveness of Tarlatamab. Researchers are excited because this combination has the potential to provide a more targeted and effective treatment option with possibly fewer side effects compared to traditional therapies.

What evidence suggests that this trial's treatments could be effective for small cell lung cancer?

This trial will study the combination of tarlatamab and AB248 for small cell lung cancer. Research has shown that tarlatamab may benefit patients with this condition. Specifically, studies have demonstrated that using tarlatamab with anti–PD-L1 drugs significantly improved survival rates for those with advanced small cell lung cancer. AB248 is being tested with tarlatamab in this trial to potentially enhance the treatment's effectiveness. This combination aims to strengthen the body's immune system to fight cancer cells. While more research is needed, early results suggest this combination could be promising for patients. ^{1 3 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for adults over 18 with confirmed extensive stage small cell lung cancer (ES-SCLC) that's worsened after treatment. They need a measurable tumor not previously treated by radiation, adequate organ function, and must provide a new or archival biopsy.

Inclusion Criteria

I have given my consent for study-related procedures.

I am at least 18 years old or the legal age in my country.

My small cell lung cancer has worsened after treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration

Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion

Variable

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

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2.5 years

What Are the Treatments Tested in This Trial?

Interventions

• AB248
• Tarlatamab

Trial Overview The study tests the safety and tolerability of combining two drugs: Tarlatamab and AB248. It aims to find the best dose for further research or the highest dose patients can tolerate without severe side effects.

How Is the Trial Designed?

Group I: Dose Exploration Experimental Treatment 2 Interventions

Multiple dose levels of AB248 will be explored in combination with tarlatamab administered via intravenous (IV) infusion.

Group II: Dose Expansion Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Asher Biotherapeutics, Inc.

Industry Sponsor

Trials

1

Recruited

550+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07037758

NCT07037758 | A Study of Tarlatamab in Combination ... A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311) (DeLLphi-311).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40839303/

Efficacy outcomes between tarlatamab and real-world ... The study findings suggest that tarlatamab offers potential clinical benefits relative to comparator treatments.

3. asherbio.com asherbio.com/2025/01/08/asher-bio-announces-clinical-trial-collaboration-and-supply-agreement-on-etakafusp-alfa-ab248-in-combination-with-bispecific-t-cell-engager-in-patients-with-small-cell-lung-cancer/

Asher Bio Announces Clinical Trial Collaboration and ... Real-world treatment patterns and outcomes of patients with small cell lung cancer progression after 2 lines of therapy. Lung Cancer. 2019 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07037758?viewType=Table&rank=2

A Study of Tarlatamab in Combination With AB248 ... The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.

5. targetedonc.com targetedonc.com/view/future-directions-with-tarlatamab-in-small-cell-lung-cancer

Future Directions With Tarlatamab in Small Cell Lung Cancer New findings reveal tarlatamab combined with anti–PD-L1 agents significantly improves survival in extensive-stage small cell lung cancer, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40934933/

Safety and activity of tarlatamab in combination with a PD ... Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive- ...

7. trial.medpath.com trial.medpath.com/clinical-trial/df20829b7473be6d/nct07037758-tarlatamab-ab248-small-cell-lung-cancer

A Study of Tarlatamab in Combination With AB248 ... - MedPath The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.

8. clinconnect.io clinconnect.io/trials/NCT07037758

A Study of Tarlatamab in Combination With AB248 in This clinical trial is studying a new combination of two medicines, tarlatamab and AB248, to see if they are safe and well-tolerated in people with extensive ...