Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-… (NCT06898957) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Study of Tarlatamab in Combination With YL201 With or Without Anti-programmed Death Ligand 1 (PD-L1) in Participants With Extensive Stage (ES) Small Cell Lung Cancer (SCLC)
United States200 participantsStarted 2025-05-16
Plain-language summary
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.
Who can participate
Age range18 Years – 99 Years
SexALL
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Inclusion Criteria:
* Participants ≥ 18 years of age (or legal adult age within country) at time of signing informed consent.
* Participants with histologically or cytologically confirmed ES-SCLC.
* For Parts 1 and 2, participant must have ES-SCLC that has progressed or recurred following at least 1 line of platinum-based anti-cancer therapy.
* For Part 3, participants must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, etoposide, and PD-(L)1 inhibitor in the first-line setting.
* At least 1 measurable lesion as defined by RECIST 1.1.
* Participants must have adequate organ function (cardiac, pulmonary, kidney, bone marrow, and liver).
Exclusion Criteria:
* Prior delta-like ligand 3 (DLL3) or B7 homolog 3 (B7-H3) targeted therapy.
* Prior exposure to topoisomerase I inhibitors or antibody-drug conjugate (ADC) with topoisomerase I inhibitor payload.
* Symptomatic central nervous system (CNS) metastases. Note: Participants with asymptomatic brain metastases are eligible as defined in the protocol.
* History of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required corticosteroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
* Baseline requirement of supplemental oxygen.
What they're measuring
1
Number of Participants Experiencing Dose-limiting toxicities (DLTs)
Timeframe: Up to Day 21
2
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)