Tarlatamab + ZL-1310 for Small Cell Lung Cancer

(DeLLphi-313 Trial)

Recruiting at 2 trial locations

Overseen By Amgen Call Center

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Strong CYP3A4, CPY2D6 inhibitors

Disqualifiers: 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

160 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The primary objective of this trial is to evaluate the safety and tolerability of tarlatamab in combination with ZL-1310 with or without durvalumab and to determine the maximum tolerated combination dose (MTCD) and/or recommended phase 2 dose (RP2D) of ZL-1310 in combination with tarlatamab.

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

Inclusion Criteria

My small cell lung cancer got worse after at least one platinum-based treatment.

I have had my cancer return or worsen after at least one platinum-based treatment.

I am fully active or can do light work despite my illness.

Exclusion Criteria

Enrollment in any tarlatamab clinical trial

I have had chest radiation within the last 90 days.

I have received treatment that targets DLL3.

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 ZL-1310 are explored in combination with tarlatamab administered intravenously

8-12 weeks

Dose Expansion

ZL-1310 is administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV

8-12 weeks

Triplet Combination

ZL-1310 is administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV

8-12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Durvalumab
• Tarlatamab
• ZL-1310

How Is the Trial Designed?

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

ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV.

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

Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).

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

ZL-1310 will be administered IV at the selected maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) in combination with tarlatamab administered IV.

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