Recruiting
Sponsor ID
20240200

A Study of Tarlatamab in Combination with AB248 in Participants with Extensive Stage Small Cell Lung Cancer (DeLLphi-311)

Sponsor ID
20240200
Clinicaltrials.gov ID
NCT07037758
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The primary objective for dose exploration and dose expansion is to evaluate the safety and tolerability of tarlatamab in combination with AB248.

The primary objective for dose exploration only is to determine the recommended dose for expansion and/or maximum tolerated combination dose (MTCD) of AB248 in combination with tarlatamab.

Additional Study Details

Phase
Phase 1
Product
Tarlatamab
Type
Interventional
Masking
None (Open Label)
Enrollment
380
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Up to 2.5 years

Dose Exploration: Number of Participants with Dose-limiting Toxicities (DLTs)

Timeframe: Up to 35 days

Secondary Outcome Measures

Maximum Serum Concentration (Cmax) of Tarlatamab

Timeframe: Up to approximately 21 weeks

Minimum Serum Concentration (Cmin) of Tarlatamab

Timeframe: Up to approximately 21 weeks

Area Under the Concentration-time Curve (AUC) of Tarlatamab

Timeframe: Up to approximately 21 weeks

Half-life (t1/2) of Tarlatamab

Timeframe: Up to approximately 21 weeks

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

Timeframe: Up to 2.5 years

Duration of Response (DOR) per RECIST 1.1

Timeframe: Up to 2.5 years

Time to Response (TTR) per RECIST 1.1

Timeframe: Up to 2.5 years

Disease Control (DC) per RECIST 1.1

Timeframe: Up to 2.5 years

Progression-free Survival (PFS) per RECIST 1.1

Timeframe: Up to 2.5 years

Time to Progression (TTP) per RECIST 1.1

Timeframe: Up to 2.5 years

Time to Subsequent Therapy

Timeframe: Up to 2.5 years

Overall Survival (OS)

Timeframe: Up to 2.5 years

Number of Participants with Anti-AB248 Antibody Formation

Timeframe: Up to 2.5 years

Locations

Location
Status
Contact Us
Location
Baptist Cancer Center
Memphis, TN, United States, 38120
Status
Recruiting
Location
Norton Cancer Institute - Downtown
Louisville, KY, United States, 40202-1703
Status
Recruiting
Location
Hacettepe Universitesi Tip Fakultesi Hastanesi
Ankara, Turkey, 06230
Status
Recruiting
Location
Ankara Bilkent Sehir Hastanesi
Ankara, Turkey, 06800
Status
Recruiting
Location
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, Turkey, 01370
Status
Recruiting
Location
Siteman Cancer Center
St Louis, MO, United States, 63110
Status
Recruiting
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