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

C

Cogent Biosciences

Status and phase

Enrolling
Phase 2
Phase 1

Conditions

FGFR2 Gene Amplification
FGFR3 Gene Fusion/Rearrangement
Intrahepatic Cholangiocarcinoma (Icc)
FGFR2 Gene Fusion/Rearrangement
Cholangiocarcinoma
FGFR2 Genetic Alterations
FGFR2 Gene Short Variants
FGFR3 Gene Short Variants
Advanced Solid Tumors
FGFR3 Gene Amplification
Other Solid Tumors, Adult
FGFR3 Genetic Alterations

Treatments

Drug: CGT4859

Study type

Interventional

Funder types

Industry

Identifiers

NCT06777316
CGT4859-24-101

Details and patient eligibility

About

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.

Enrollment

110 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

  1. Histologically confirmed locally advanced, metastatic, and/or unresectable iCCA or other solid tumor with documented FGFR2/3 alteration in blood and/or tumor.
  2. Previously treated with, not appropriate for, or declined standard-of-care first-line treatment.
  3. Have measurable disease per RECIST v1.1.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  5. Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits.
  6. 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.

Key Exclusion Criteria:

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

110 participants in 2 patient groups

Phase 1: Dose Escalation
Experimental group
Description:
Multiple doses of CGT4859 for oral administration
Treatment:
Drug: CGT4859
Phase 2: Signal Seeking
Experimental group
Description:
Oral dose of CGT4859 at the RP2D as determined in Phase 1
Treatment:
Drug: CGT4859

Trial contacts and locations

10

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Central trial contact

Cogent Biosciences, Inc.

Data sourced from clinicaltrials.gov

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