Tarlatamab + YL201 for Lung Cancer

((DeLLphi-310) Trial)

Recruiting at 1 trial location

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Topoisomerase inhibitors

Disqualifiers: DLL3 therapy, Symptomatic CNS metastases, ILD, others

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

Compensation: Varies

Number of Visits: Unknown

200 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this study is to evaluate the safety and tolerability of tarlatamab in combination with YL201 with or without anti-PD-L1.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

This trial is for adults with extensive stage small cell lung cancer (ES-SCLC). Participants must have had the disease progress after at least one platinum-based therapy, except for Part 3 where no prior treatment other than one cycle of specific drugs is allowed. They need at least one measurable lesion and good organ function.

Inclusion Criteria

I am at least 18 years old or considered an adult by law.

My small cell lung cancer has worsened after platinum-based treatment.

I have at least one tumor that can be measured.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Exploration

Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing

Dose Expansion

YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose

Triplet Combination

YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

Treatment Details

Interventions

• Atezolizumab
• Durvalumab
• Tarlatamab
• YL201

Trial Overview The study tests the safety and tolerability of a new combination: Tarlatamab with YL201, with or without an anti-PD-L1 drug like Durvalumab or Atezolizumab. It aims to see how patients handle this mix of treatments.

Participant Groups

Group I: Triplet Combination (Part 3) Experimental Treatment 4 Interventions

YL201 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (atezolizumab or durvalumab) administered IV at a fixed dose.

Group II: Dose Exploration (Part 1) Experimental Treatment 2 Interventions

Multiple dose levels of YL201 will be explored in combination with tarlatamab administered intravenously (IV) at a fixed dose using one-step dosing.

Group III: Dose Expansion (Part 2) Experimental Treatment 2 Interventions

YL201 will be administered at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV at a fixed dose.

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

MediLink

Collaborator

Trials

1

Recruited

200+