First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With ICC and Other Advanced Solid Tumors
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Breast Cancer
- Cholangiocarcinoma
- Endometrial Cancer
- FGFR2 Amplification
- FGFR2 Gene Activation
- FGFR2 Gene Mutation
- FGFR2 Gene Rearrangement
- FGFR2 Gene Translocation
- Gastric Cancer
- Intrahepatic Cholangiocarcinoma
- Solid Tumor, Adult
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Part 1 (multiple ascending doses, QD or BID): • unresectable or metastatic ICC or other unresectable or metastatic solid tumor Part 2 (RP2D determined in Part 1): Group 1: ICC with a FGFR2 fusion previously treated with a pan-FGFR inhibitor (eg. pemigatinib [Pemazyre], erdafitinib [Balversa], infigratinib, TAS-120) Group 2: ICC with a FGFR2 fusion not previously treated with a pan-FGFR inhibitor Group 3: patients with an FGFR2 fusion and solid tumor other than ICC. Group 4: unresectable or metastatic solid tumor patients with FGFR2 amplification. Group 5: unresectable or metastatic solid tumor patients with an oncogenic FGFR2 mutation. Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04526106
- Collaborators
- Not Provided
- Investigators
- Not Provided
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