CGT4859 for Bile Duct Cancer

Recruiting at 9 trial locations

Overseen By Cogent Biosciences, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Cogent Biosciences, Inc.

Disqualifiers: Brain metastases, Corneal disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that you should not have received chemotherapy or anticancer therapies recently, so it's best to discuss your specific medications with the trial team.

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adults with intrahepatic cholangiocarcinoma (a type of liver bile duct cancer) or other advanced solid tumors that have specific genetic changes in FGFR2 and/or FGFR3. Participants should meet certain health standards to be included.

Inclusion Criteria

I am fully active or can carry out light work.

Have measurable disease per RECIST v1.1

Have clinically acceptable local laboratory screening results (clinical chemistry and hematology) within certain limits

Exclusion Criteria

I haven't had cancer treatment or radiation recently.

I don't have active brain cancer symptoms or have been stable without steroids for 2+ months.

I do not have major eye problems like corneal or retinal disorders.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Escalation

Participants receive multiple doses of CGT4859 to determine the maximum tolerated dose and recommended phase 2 dose

12 months

Phase 2: Signal Seeking

Participants receive an oral dose of CGT4859 at the recommended phase 2 dose to evaluate safety and antitumor activity

9 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CGT4859

Trial Overview The study is testing CGT4859, a drug aimed at targeting cancers with certain genetic alterations. It's an early-phase trial to assess how safe it is, how the body processes it, and its effectiveness against these cancers.

Participant Groups

Group I: Phase 2: Signal Seeking Experimental Treatment 1 Intervention

Oral dose of CGT4859 at the RP2D as determined in Phase 1

Group II: Phase 1: Dose Escalation Experimental Treatment 1 Intervention

Multiple doses of CGT4859 for oral administration

Who Is Running the Clinical Trial?

Cogent Biosciences, Inc.

Lead Sponsor

Trials

11

Recruited

1,100+