Active — Not RecruitingPhase 1/2

A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors

United States110 participantsStarted 2025-01-22

Plain-language summary

This is an open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetic (what the body does to the drug), pharmacodynamic (what the drug does to the body), and antitumor activity of CGT4859 in adult participants with intrahepatic cholangiocarcinoma (iCCA) or other advanced solid tumors with FGFR2 and/or FGFR3 genetic alternations.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
✓. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
✓. Have measurable disease per RECIST v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
✓. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention.

Exclusion criteria

✕. Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
✕. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
✕. Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
✕. Received more than 2 prior FGFRi therapies
✕. Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.

What they're measuring

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs

Timeframe: Approximately 12 months

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results

Timeframe: Approximately 12 months

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results

Timeframe: Approximately 12 months

Phase 2: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)

Timeframe: Approximately 8 months

Trial details

NCT IDNCT06777316

SponsorCogent Biosciences, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03

View on ClinicalTrials.gov More Intrahepatic Cholangiocarcinoma (Icc) trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
✓. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
✓. Have measurable disease per RECIST v1.1.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
✓. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
✓. Resolution of toxicities from prior therapy to ≤Grade 1 (or baseline), including resolution of clinically significant laboratory abnormalities, before the first dose of study drug. Exceptions are alopecia, hypothyroidism, or type 1 diabetes mellitus controlled with medical intervention, and paronychia controlled with local intervention.

Exclusion criteria

✕. Received chemotherapy or anticancer therapies or radiotherapy within certain timeframes before first dose of study drug.
✕. Major surgeries (eg, abdominal laparotomy) within 4 weeks of the first dose of study drug.
✕. Clinically significant corneal or retinal disorders or current evidence of retinal detachment.
✕. Received more than 2 prior FGFRi therapies
✕. Active, symptomatic, or untreated brain metastases unless the participant is clinically stable and off corticosteroids for ≥2 months.

What they're measuring

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - AEs

Timeframe: Approximately 12 months

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - Laboratory results

Timeframe: Approximately 12 months

Phase 1: Determine the maximum tolerated dose (MTD) and RP2D of CGT4859 - ECG results

Timeframe: Approximately 12 months

Phase 2: Evaluate antitumor activity of CGT4859 - Objective Response Rate (ORR)

Timeframe: Approximately 8 months