Unresectable or metastatic cholangiocarcinoma (CCA), other advanced solid tumors with an FGFR2-alteration or other potential FGFR2-dependent tumors MedDRA version: 27.0 Level: LLT Classification code 10073077 Term: Intrahepatic cholangiocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10065252 Term: Solid tumor System Organ Class: 10029104 - Neoplasms benign, malignant and unspecifie
Conditions
Sponsors
Relay Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main inclusion criteria for the study, including specific criteria for Part 1, 2 and 3 can be found in the study protocol (section 5.2). Part 4 14. Patient is currently receiving RLY-4008 on RLY-4008-101 Study and benefiting from treatment as assessed by the investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 363 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 187
Exclusion criteria
Exclusion criteria: Main exclusion criteria for the study, including specific criteria for Part 1, 2 and 3 can be found in the study protocol (section 5.3). Part 4 21. Patient has permanently discontinued treatment with RLY-4008 for any reason before enrolling into Part 4.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Part 1 • To determine the MTD and RP2D of RLY-4008 • To determine the safety and tolerability of RLY-4008 Part 2 and 3 • To evaluate the efficacy of RLY-4008 by objective response rate (ORR) assessed by Independent Review Committee (IRC) Part 4 • To assess the safety and tolerability of RLY-4008. ;Secondary Objective: Part 1 • To evaluate FGFR2 status in blood and tumor tissue by next generation nucleic acid sequencing • To define the PK profile of RLY-4008 and its metabolites if appropriate • To assess the pharmacodynamics of RLY-4008 by monitoring blood markers (eg. CA 19-9, CEA, FGF23) • To characterize the preliminary anti-tumor activity of RLY-4008 per RECIST 1.1 Part 2 and 3 • To determine the duration of response (DOR) by IRC ;Primary end point(s): • MTD and RP2D • Overall safety profile of RLY-4008 as assessed by the type, frequency, severity, timing and relationship to RLY-4008 of any adverse events (AEs), serious AEs (SAEs), changes in vital signs, electrocardiograms (ECGs) and safety laboratory tests. All AEs and SAEs will be collected and graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0. • To evaluate the efficacy of RLY-4008 by objective response rate (ORR) assessed by Independent Review Committee (IRC) using RECIST v.1.1 Part 4 • To assess the safety and tolerability of RLY-4008 • Frequency, severity, timing, and relationship to RLY-4008 of any AEs and SAEs. All AEs and SAEs will be collected and graded according to NCI CTCAE, Version 5.0. • Dose modification (e.g., dose interruption, dose reduction, dose discontinuation) ;Timepoint(s) of evaluation of this end point: The minimum duration of participation for a patient is approximately 3 months including a Screening Period up to 28 days, a Treatment Period of up to 1 cycle (28 days), an End of Treatment visit within 14 days of the last dose of RLY-4008, and a Safety Follow-up to document any new AE or r | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • FGFR2 genotype in blood and tumor tissue • PK parameters of RLY-4008 (and its metabolites if appropriate) including, but not limited to Maximum Concentration (Cmax), Time to Maximum Concentration (Tmax), Area Under the Concentration-Time Curve (AUC), effective half-life(T1/2eff), clearance (CL/F), and other relevant parameters • Pharmacodynamic parameters: including, but not limited to blood markers (eg. CA 19-9, CEA, FGF23) • Overall response rate (ORR), Duration of Response (DOR), and Disease Control Rate (DCR) per RECIST 1.1 • To determine the duration of response (DOR) by Independent Review Committee (IRC) using RECIST v.1.1 ;Timepoint(s) of evaluation of this end point: Plasma samples for extensive PK will be collected on Cycle 1 Day 1 (through 24 hours post dose) and Cycle 1 Day 15 (through 8 hours post dose). On Day 1 of Cycles 2, 3, and 4, samples will only be collected pre-dose (within 30 minutes pre-dose). ORR is defined as the proportion of patients achieving Complete response (CR) and partial response (PR). Confirmed responses are those that persist on repeat tumor assessments for at least 4 weeks after initial documentation or response. Otherwise, the patient will be counted as a non-responder in the assessment of ORR. DOR is defined as the time from first documentation of CR or PR until the time of first documentation of progressive disease (PD) or death due to any cause. | — |
Countries
Australia, France, Germany, Hong Kong, Korea, Republic of, Netherlands, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States
Contacts
Public ContactClinOps
Relay Therapeutics, Inc.
Outcome results
None listed