What side effects are associated with this type of intervention?

Common treatments for bile duct cancer include systemic chemotherapy (e.g., gemcitabine plus cisplatin), targeted therapies (e.g., FGFR2 inhibitors like RLY-4008), and locoregional therapies (e.g., radiofrequency ablation). Known side effects of these treatments can vary. For systemic chemotherapy, side effects often include nausea, vomiting, fatigue, neutropenia, and thrombocytopenia. FGFR2 inhibitors, such as RLY-4008, may cause side effects like hyperphosphatemia, dry mouth, fatigue, and gastrointestinal issues. Locoregional therapies can lead to localized pain, infection, and biliary complications.

What prior FDA approvals exist?

FGFR2 inhibitors, such as RLY-4008, are being studied for their efficacy in treating bile duct cancer, specifically cholangiocarcinoma with FGFR2 fusions or rearrangements. Prior FDA approvals in this category include pemigatinib (Pemazyre), which was approved in April 2020 for previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. Another similar drug is infigratinib (Truseltiq), approved in May 2021 for the same indication. These approvals highlight the targeted approach in treating genetically defined subtypes of bile duct cancer.

What other types of research exist?

Promising alternatives to RLY-4008 for bile duct cancer patients include: 1) Silmitasertib combined with gemcitabine and cisplatin, which has shown improved progression-free survival and overall survival in a Phase 1b/2 study. 2) Gemcitabine plus cisplatin, a standard regimen that has been effective in various trials. 3) Combination therapies involving gemcitabine with other agents like S-1 or capecitabine, which have shown efficacy in advanced/recurrent biliary tract cancer.

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Tyrosine Kinase Inhibitor

RLY-4008 for Bile Duct Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Relay Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called RLY-4008 in patients with hard-to-treat cancers that can't be removed by surgery or have spread. The drug works by blocking a protein that helps cancer cells grow.

Who is the study for?

This trial is for adults with advanced bile duct cancer or other solid tumors that have specific genetic changes in FGFR2. They should be able to perform daily activities with little help (ECOG 0-1) and may have had previous treatments, but not a drug targeting FGFR2. People can't join if they have active infections like HIV/HBV/HCV, serious heart issues, eye problems from similar drugs, poor organ function, or certain electrical heart disturbances.

What is being tested?

RLY-4008 is being tested in patients with intrahepatic cholangiocarcinoma (ICC) and other solid tumors that haven't responded well to standard treatments. The study has three parts: finding the right dose of RLY-4008 (dose escalation), seeing how well it works at this dose (dose expansion), and long-term follow-up (extension).

What are the potential side effects?

While the exact side effects of RLY-4008 are still being studied as it's a new drug, potential risks could include reactions related to liver function since it targets bile duct cancer. Other common side effects might involve digestive issues, fatigue, skin reactions or increased risk of infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 4: RolloverExperimental Treatment1 Intervention

Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.

Group II: Part 3: ExtensionExperimental Treatment1 Intervention

Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.

Group III: Part 2: Dose ExpansionExperimental Treatment1 Intervention

Oral dose of RLY-4008 as determined during Part 1 Dose Escalation.

Group IV: Part 1: Dose EscalationExperimental Treatment1 Intervention

Multiple doses of RLY-4008 for oral administration.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bile duct cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy drugs like gemcitabine and cisplatin work by damaging the DNA of cancer cells, preventing them from dividing and growing. Targeted therapies, such as FGFR2 inhibitors like RLY-4008, specifically block the fibroblast growth factor receptor 2 (FGFR2) pathway, which is often mutated in cholangiocarcinoma, thereby inhibiting tumor growth and survival. Immunotherapies, such as pembrolizumab, enhance the body's immune response against cancer cells. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment based on the genetic profile of their tumor, potentially leading to better outcomes and personalized care.

Silmitasertib plus gemcitabine and cisplatin first-line therapy in locally advanced/metastatic cholangiocarcinoma: A Phase 1b/2 study.Dramatic response to dabrafenib and trametinib combination in a BRAF V600E-mutated cholangiocarcinoma: implementation of a molecular tumour board and next-generation sequencing for personalized medicine.Combining biological agents and chemotherapy in the treatment of cholangiocarcinoma.