Terminated/Withdrawn
Sponsor ID
20210104

A Study Evaluating Bemarituzumab in Solid Tumors with fibroblast growth factor receptor 2b (FGFR2b) OverexpressionFORTITUDE-301

Sponsor ID
20210104
Clinicaltrials.gov ID
NCT05325866
EUCTIS ID
N/A
EudraCT ID
2023-505455-44

Study Details

The primary objectives of this study are to observe the safety and tolerability of bemarituzumab and to evaluate preliminary antitumor activity.

Additional Study Details

Phase
Phase 1/Phase 2
Product
Bemarituzumab
Type
Interventional
Masking
None (Open Label)
Enrollment
260
Additional Study Details

Protocol Summary

Primary Outcome Measures

Part 1: Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

Timeframe: Day 1 to Day 28

Part 1: Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Part 1: Number of Participants Who Experience a Treatment-related Adverse Event

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Part 2: Objective Response (OR) Rate

Timeframe: Up to approximately 2 years

Secondary Outcome Measures

Part 1: OR Rate

Timeframe: Up to approximately 2 years

Parts 1 and 2: Disease Control (DC) Rate

Timeframe: Up to approximately 2 years

Parts 1 and 2: Duration of Response (DOR)

Timeframe: Up to approximately 2 years

Parts 1 and 2: Time to Response

Timeframe: Up to approximately 2 years

Parts 1 and 2: Progression-free Survival (PFS)

Timeframe: Up to approximately 2 years

Parts 1 and 2: Overall Survival (OS)

Timeframe: Up to approximately 2 years

Part 2: Number of Participants Who Experience a TEAE

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Part 2: Number of Participants Who Experience a Treatment-related AE

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Parts 1 and 2: Area Under the Concentration Time Curve (AUC) of Bemarituzumab

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Parts 1 and 2: Maximum Observed Serum Concentration (Cmax) of Bemarituzumab

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Parts 1 and 2: Observed Concentration at the End of a Dose Interval (Ctrough) of Bemarituzumab

Timeframe: Day 1 to 28 days after last dose (a maximum of 2 years)

Locations

Location
Status
Contact Us
Location
St John of God Murdoch Hospital
Murdoch, WA, Australia, 6150
Status
Recruiting
Location
Grand Hopital de Charleroi - Site des Viviers
Charleroi, Belgium, 6060
Status
Recruiting
Location
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles, Belgium, 1200
Status
Recruiting
Location
Universitair Ziekenhuis Gent
Gent, Belgium, 9000
Status
Recruiting
Location
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Status
Recruiting
Location
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Status
Recruiting
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