NL-OMON54283
Recruiting
Not Applicable
A First-in-Human Study of Highly Selective FGFR2 Inhibitor, RLY-4008, in Patients With Intrahepatic Cholangiocarcinoma (ICC) and Other Advanced Solid Tumors - RLY-4008-101
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bile Duct Cancer
- Sponsor
- Relay Therapeutics, Inc.
- Enrollment
- 4
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General Inclusion Criteria
- •1\. Patient is willing and able to provide written informed consent for the
- •study prior to the performance of any study\-specific procedures.
- •2\. Patient is \>\= 18 years of age.
- •3\. Patient must have disease that is refractory to standard therapy, disease
- •that has not adequately responded to standard therapy, disease for which
- •standard or curative therapy does not exist, or the patient must be intolerant
- •to or have declined standard therapy.
- •4\. Patient must have measurable disease per Response Evaluation Criteria in
- •Solid Tumors, Version 1\.1 (RECIST v1\.1\).
Exclusion Criteria
- •Patients who meet one or more of the following criteria will not be considered
- •eligible to participate in the clinical study:
- •1\. Patient has a cancer other than FGFR2 fusion/rearrangement positive CCA and
- •has a known primary driver alteration that is amenable to approved targeted
- •therapy (eg, EGFR, ALK, ROS1, RET, HER2, BRAF, IDH1, KRAS). Patients may be
- •eligible after consultation with the Sponsor.
- •2\. Patient has ongoing clinically significant FGFRi\-induced retinal detachment
- •or an ongoing clinically significant corneal or retinal disorder.
- •3\. Patient does not have the following adequate organ function assessments
- •within 7 days prior to the first dose of RLY\-4008:
Outcomes
Primary Outcomes
Not specified
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