What side effects are associated with this type of intervention?

Common treatments for bile duct cancer, including targeted therapies like kinase inhibitors and chemotherapy regimens, have a range of side effects. Targeted therapies such as FGFR inhibitors can cause severe onycholysis, eyelash trichomegaly, and other dermatologic issues. Chemotherapy regimens, such as gemcitabine combined with cisplatin or oxaliplatin, often result in hematologic toxicities (e.g., neutropenia, thrombocytopenia), gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea), and fatigue. These side effects are generally manageable but require careful monitoring and supportive care.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of bile duct cancer have included targeted therapies and kinase inhibitors. For instance, Pemigatinib, a fibroblast growth factor receptor (FGFR) inhibitor, has been approved for previously treated, locally advanced, or metastatic cholangiocarcinoma with an FGFR2 fusion or rearrangement. Other investigational treatments include various combinations of chemotherapy agents like gemcitabine and cisplatin, as well as newer targeted therapies being evaluated in clinical trials, such as TT-00420, which is a kinase inhibitor.

What other types of research exist?

Promising alternatives to TT-00420 for bile duct cancer patients include: <ol> <li>Pemigatinib: An FGFR inhibitor approved for previously treated, locally advanced or metastatic cholangiocarcinoma.</li> <li></li> </ol> Infigratinib: Another FGFR inhibitor used for similar indications. 3. Erdafitinib: An FGFR inhibitor with available prescribing information for advanced cholangiocarcinoma. 4. Dabrafenib plus Trametinib: A combination therapy for patients with BRAFV600E-mutated biliary tract cancer. 5. Systemic chemotherapy options such as gemcitabine plus cisplatin, capecitabine plus gemcitabine, or fluoropyrimidine-based regimens.

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Unknown

TT-00420 for Bile Duct Cancer

Phase 2

Waitlist Available

Led By Milind Javle, MD

Research Sponsored by TransThera Sciences (Nanjing), Inc.

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

≥ 18 years of age, at the time of signing informed consent

Must not have

Impaired cardiac function or significant diseases

Women who are pregnant or lactating

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new medication called TT-00420, which is taken as a tablet. It is aimed at adults with advanced bile duct cancer that cannot be surgically removed. The drug works by blocking proteins that help cancer cells grow, and it is being tested on patients with specific genetic changes in their cancer.

Who is the study for?

Adults with advanced cholangiocarcinoma (bile duct cancer) who've had prior chemotherapy can join this trial. They must have a certain level of health, confirmed by blood tests and organ function checks, and not be pregnant or breastfeeding. Participants need to use birth control during the study.

What is being tested?

The trial is testing TT-00420 tablets for safety and effectiveness in treating bile duct cancer. It's an open-label study, meaning everyone knows they're getting the drug, and it involves multiple centers where patients are grouped based on their genetic alterations related to FGFR2.

What are the potential side effects?

While specific side effects of TT-00420 aren't listed here, common ones for cancer treatments include nausea, fatigue, risk of infection due to low blood counts, liver issues shown by blood tests changes, diarrhea or constipation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or can carry out light work.

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I am 18 years old or older.

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My blood and organ tests meet the required levels for treatment.

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I have cholangiocarcinoma that can't be removed by surgery and have had chemotherapy.

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My cancer has been tested for FGFR gene changes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have heart problems or significant heart diseases.

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I am not pregnant or breastfeeding.

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I have untreated or worsening brain metastases.

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I cannot swallow or tolerate pills.

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I have an uncontrolled Hepatitis B or C infection.

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I am currently taking prescribed medications.

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I do not have ongoing severe diarrhea or any GI conditions that could affect medication absorption.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR) in patients with FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor (Cohort A1)

Secondary study objectives

Disease Control Rate (DCR) (All Cohorts)

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (All Cohorts)

Other study objectives

Genetic Alteration Status

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: Cohort CExperimental Treatment1 Intervention

Negative for FGFR alterations (FGFR wild-type)

Group II: Cohort BExperimental Treatment1 Intervention

Other FGFR alterations, including FGFR2 mutations and FGFR1/3 alterations, including fusions

Group III: Cohort A2Experimental Treatment1 Intervention

FGFR2 fusions who have previously responded on at least one previous treatment with an FGFR inhibitor and discontinued due to disease progression

Group IV: Cohort A1Experimental Treatment1 Intervention

FGFR2 fusions who have failed at least one previous treatment with an FGFR inhibitor

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

TT-00420

2021

Completed Phase 2

~260

0 / 12Eligibility criteria met

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

The most common treatments for bile duct cancer include targeted therapies and kinase inhibitors. These treatments work by specifically targeting molecular pathways that are crucial for cancer cell growth and survival. For instance, kinase inhibitors block enzymes known as kinases, which are involved in signaling pathways that regulate cell division and survival. By inhibiting these enzymes, the drugs can effectively halt the proliferation of cancer cells. This is particularly important for bile duct cancer patients as these targeted treatments can offer a more personalized and effective approach, potentially leading to better outcomes and fewer side effects compared to traditional chemotherapy.

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.Gemcitabine and oxaliplatin with or without erlotinib in advanced biliary-tract cancer: a multicentre, open-label, randomised, phase 3 study.