Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)

Part of paid clinical trials in Goodyear, Arizona.

Sponsor
Amgen
Study ID
NCT07531095
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • ZL-1310 — DRUG
    ZL-1310 will be administered as an IV infusion.
  • Tarlatamab — DRUG
    Tarlatamab will be administered as an IV infusion.
  • Durvalumab — DRUG
    Durvalumab will be administered as an IV infusion.

Study Details

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.

Key Dates

First listed
Apr 15, 2026
Start date
Apr 21, 2026
Status verified
Aug 2026
Primary completion
May 21, 2028
Completion
May 21, 2031

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Exploration (Part 1)
    Multiple dose levels of ZL-1310 will be explored in combination with tarlatamab administered intravenously (IV).
  • 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.
  • 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.

Primary Outcome Measure

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 3.5 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope Cancer Center PhoenixGoodyearArizona85338-
Moffitt Cancer CenterTampaFlorida33612-
City of Hope ChicagoZionIllinois60099-
Health Partners Cancer Center at Regions HospitalSaint PaulMinnesota55101-
New York University Cancer InstituteNew YorkNew York10016-
Baptist Cancer CenterMemphisTennessee38120-
Next VirginiaFairfaxVirginia22031-

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OncologyLung oncologyLung disease
By research site
City of Hope Cancer Center Phoenix· Goodyear, AZMoffitt Cancer Center· Tampa, FLCity of Hope Chicago· Zion, ILHealth Partners Cancer Center at Regions Hospital· Saint Paul, MNNew York University Cancer Institute· New York, NYBaptist Cancer Center· Memphis, TN

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