CGT4859 for Bile Duct Cancer

Recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, CGT4859, to determine its safety and effectiveness in treating bile duct cancer and other advanced solid tumors with specific genetic changes (FGFR2 and FGFR3). The study aims to understand the drug's interaction with the body and its potential to shrink tumors. Participants will receive the drug in varying doses to identify the optimal treatment amount. This trial may suit those with advanced bile duct cancer or similar tumors with the specified genetic changes who have not succeeded with other treatments. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new drug.

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.

Is there any evidence suggesting that CGT4859 is likely to be safe for humans?

Research shows that CGT4859 is being tested for safety in people with bile duct cancer and other advanced solid tumors. Specific safety data from past studies is not yet available, as the trial is in an early stage (Phase 1/2). Researchers are closely observing how the body processes the drug and its effects on the body.

At this stage, the focus is on finding the right dose with the fewest side effects. Early-stage trials usually involve fewer participants, so safety information can be limited. Since CGT4859 targets specific genetic changes (FGFR2 and FGFR3), the trial is particularly interested in how individuals with these changes respond to the treatment.

The main goal is to ensure CGT4859 is safe and to understand its function in the body. Careful monitoring helps quickly identify and manage any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for bile duct cancer, which often include surgery, chemotherapy, and radiation, CGT4859 is unique because it is an oral medication that targets the disease differently. Researchers are excited about CGT4859 due to its potential new mechanism of action, which might inhibit cancer growth more effectively than traditional therapies. Additionally, being an oral treatment, it could offer a more convenient and less invasive option for patients, which is a significant advantage over current methods that require more intensive and hospital-based procedures.

What evidence suggests that CGT4859 might be an effective treatment for bile duct cancer?

Research has shown that CGT4859 targets two proteins, FGFR2 and FGFR3, which aid in cell growth and division. These proteins often mutate in bile duct cancer, making them suitable targets for treatment. Early results suggest that blocking these proteins might slow or halt cancer cell growth. The trial will evaluate CGT4859 in two phases: a Phase 1 dose escalation to determine the optimal dosage, followed by a Phase 2 signal-seeking phase at the recommended dose. While detailed data on its efficacy is still being collected, the focus on FGFR2 and FGFR3 is based on a strong understanding of their role in cancer. Initial studies are promising, but further research is needed to confirm these findings. ^{2 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. mayo.edu mayo.edu/research/clinical-trials/diseases-conditions/cholangiocarcinoma-(bile-duct-cancer)

Cholangiocarcinoma (Bile Duct Cancer) Clinical Trials The long term research goal and objective of this application is to improve the clinical outcomes of patients with biliary tract cancers and germ cell tumors.

2. withpower.com withpower.com/trial/cgt4859-for-bile-duct-cancer-9b444

CGT4859 for Bile Duct Cancer It's an early-phase trial to assess how safe it is, how the body processes it, and its effectiveness against these cancers. How Is the Trial Designed? 2 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06777316

NCT06777316 | A Study of an FGFR2/3 Inhibitor (CGT4859 ... 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 ...

4. moffitt.org moffitt.org/clinical-trials-and-studies/clinical-trial-23480/

Clinical Trial 23480 Study Title: A Phase 1/2 Study of a Selective FGFR2/3 Inhibitor, CGT4859, in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors Harboring ...

5. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/566415

A Study of an FGFR2/3 Inhibitor (CGT4859) in Patients ... 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 ...

6. med.stanford.edu med.stanford.edu/chinlab/clinicaltrials/_jcr_content/main/panel_builder_1623764811/panel_0/clinicaltrials.html?view=formSubmission&source=browseConditions&serviceLineId=&condition=Bile%20Duct%20Cancer%20%28Cholangiocarcinoma%29&conditionId=46550&recruitingStatus=RECRUITING

Bile Duct Cancer (Cholangiocarcinoma) ... (CGT4859) in Patients With Cholangiocarcinoma and Other Advanced Solid Tumors. This is an open-label, phase 1/2 study evaluating the safety, tolerability ...