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Recruitment Complete
Sponsor ID
20240124

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)DeLLphi-310

Sponsor ID
20240124
Clinicaltrials.gov ID
NCT06898957
EUCTIS ID
N/A
EudraCT ID
N/A
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Study Details

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.

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
29
Additional Study Details

Protocol Summary

Primary Outcome Measures

Number of Participants Experiencing Dose-limiting toxicities (DLTs)

Timeframe: Up to Day 21

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Timeframe: Up to 3.5 Years

Secondary Outcome Measures

Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

Timeframe: Up to 3.5 Years

Duration of Response (DOR) per RECIST 1.1

Timeframe: Up to 3.5 Years

Time to Response (TTR) per RECIST 1.1

Timeframe: Up to 3.5 Years

Disease Control Rate (DCR) per RECIST 1.1

Timeframe: Up to 3.5 Years

Progression-free Survival (PFS) per RECIST 1.1

Timeframe: Up to 3.5 Years

Time to Progression (TTP) per RECIST 1.1

Timeframe: Up to 3.5 Years

Time to Subsequent Therapy

Timeframe: Up to 3.5 Years

Overall Survival (OS)

Timeframe: Up to 3.5 Years

Maximum Serum Concentration (Cmax) of Tarlatamab

Timeframe: Up to Week 36

Minimum Serum Concentration (Cmin) of Tarlatamab

Timeframe: Up to Week 36

Area Under the Concentration-time Curve (AUC) Over the Dosing Interval for Tarlatamab

Timeframe: Up to Week 36

Half-life (t1/2) of Tarlatamab

Timeframe: Up to Week 36

Locations

Location
Status
Contact Us
Location
Siteman Cancer Center
St. Louis, MO, United States, 63110
Status
Recruiting
Location
Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Status
Recruiting
Location
West China Hospital of Sichuan University
Chengdu, Sichuan, China, 611135
Status
Recruiting
Location
Fujian Cancer Hospital
Fuzhou, China, 350011
Status
Recruiting
Location
University of Texas MD Anderson Cancer Center
Houston, TX, United States, 77030
Status
Recruiting
Location
Swedish Medical Center
Seattle, WA, United States, 98104
Status
Recruiting
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Study Info
Age
18 - 99 Years
Condition
  • Lung Cancer - Small Cell
    • Sex
    All
    Trial Dates
    May 2025 - Jun 2031
    Inclusion and Exclusion Criteria
    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, subjects must have ES-SCLC that has progressed or recurred following at least 1 prior line of platinum-based anti-cancer therapy received either for LS-SCLC or ES-SCLC. • For Part 3, subjects must have ES-SCLC and no prior systemic treatment for ES SCLC other than 1 cycle of platinum-based chemotherapy, and etoposide, and with or without 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.