Print

Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age ≥ 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 SCLC: - For Part 1, participants must have SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy. - For Parts 1 and 2, participants must have progressed or recurred following at least 1 line of platinum-based therapy. No prior tarlatamab is allowed in Cohort 2-1. - For Part 3, participants must have extensive-stage SCLC (ES-SCLC) with no prior systemic treatment other than 1 cycle of platinum-based chemotherapy. Note: Participants with prior treatment for limited-stage SCLC (LS-SCLC) before diagnosis of ES SCLC are permitted. - Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. - At least 1 measurable lesion as defined per RECIST v1.1 within 21-day screening period, not previously irradiated. - Adequate organ function (hematological, coagulation, renal, hepatic, pulmonary, and cardiac function).

Exclusion Criteria

  • Symptomatic CNS metastases. Participants with treated brain metastases are eligible provided they meet the criteria specified in the protocol. - History of interstitial lung disease (ILD)/pneumonitis. - Received thoracic radiation therapy within 90 days prior to first dose of trial intervention. - Prior therapy with any delta-like ligand 3 (DLL3)-directed therapy. - Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload. - Receiving strong CYP3A4 or CPY2D6 inhibitors within 14 days or 5 half-lives (whichever is longer) before the first dose of trial treatment. - Enrollment in any tarlatamab clinical trial.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dose Exploration (Part 1) 		Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).
  • Drug: ZL-1310
    ZL-1310 will be administered as an IV infusion.
  • Drug: Tarlatamab
    Tarlatamab will be administered as an IV infusion.
    Other names:
    • IMDELLTRA
Experimental
Dose Expansion (Part 2) 		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.
  • Drug: ZL-1310
    ZL-1310 will be administered as an IV infusion.
  • Drug: Tarlatamab
    Tarlatamab will be administered as an IV infusion.
    Other names:
    • IMDELLTRA
Experimental
Triplet Combination (Part 3) 		ZL-1310 will be administered at MTCD or RP2D in combination with tarlatamab and an anti-PD-L1 (durvalumab) each administered IV.
  • Drug: ZL-1310
    ZL-1310 will be administered as an IV infusion.
  • Drug: Tarlatamab
    Tarlatamab will be administered as an IV infusion.
    Other names:
    • IMDELLTRA
  • Drug: Durvalumab
    Durvalumab will be administered as an IV infusion.

Recruiting Locations

New York University Cancer Institute
New York, New York 10016

Baptist Cancer Center
Memphis, Tennessee 38120

Next Virginia
Fairfax, Virginia 22031

More Details

Status
Recruiting
Sponsor
Amgen

Study Contact

Amgen Call Center
866-572-6436
medinfo@amgen.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.