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Tinengotinib for Bile Duct Cancer (FIRST-308 Trial)

Phase 3
Recruiting
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from first study drug administration until the date of death from any cause, assessed up to 24 months.
Awards & highlights

FIRST-308 Trial Summary

This trial will compare the safety & effectiveness of a new drug to existing treatments for advanced cholangiocarcinoma, a type of bile duct cancer.

Who is the study for?
This trial is for adults over 18 with bile duct cancer that can't be surgically removed or has spread, and have specific FGFR2 gene changes. Participants must have tried one chemotherapy and one approved FGFR inhibitor but not more than that. They shouldn't have worsening brain metastases, be on other cancer treatments, or have another progressing cancer.Check my eligibility
What is being tested?
The study compares the effectiveness of a new drug called Tinengotinib (at two different doses) against treatments chosen by physicians in patients with cholangiocarcinoma who haven’t responded to previous therapies. It's a randomized controlled trial meaning participants are randomly assigned to receive either the experimental drug or standard treatment.See study design
What are the potential side effects?
While specific side effects of Tinengotinib aren't listed here, similar drugs often cause diarrhea, mouth sores, fatigue, nail changes, high blood pressure and may affect liver function. Side effects vary from person to person.

FIRST-308 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from first study drug administration until the date of death from any cause, assessed up to 24 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from first study drug administration until the date of death from any cause, assessed up to 24 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part A: Incidence, duration, and severity of adverse events (AEs)
Part B: PFS by BICR
Secondary outcome measures
Part A: DOR by Investigator
Part A: ORR by Investigator
Part B: Duration of Response (DOR) by BICR and by Investigator
+3 more

FIRST-308 Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Tinengotinib 8 mg QDExperimental Treatment1 Intervention
Tinengotinib will be administered in 28-day cycles.
Group II: Tinengotinib 10 mg QDExperimental Treatment1 Intervention
Tinengotinib will be administered in 28-day cycles.
Group III: Physician's ChoiceActive Control1 Intervention
Physician's Choice treatments include FOLFOX or FOLFIRI

Find a Location

Who is running the clinical trial?

TransThera Sciences (Nanjing), Inc.Lead Sponsor
14 Previous Clinical Trials
711 Total Patients Enrolled
Milind Javle, MDPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
152 Total Patients Enrolled

Media Library

Physician's Choice Clinical Trial Eligibility Overview. Trial Name: NCT05948475 — Phase 3
Bile Duct Cancer Research Study Groups: Tinengotinib 8 mg QD, Tinengotinib 10 mg QD, Physician's Choice
Bile Duct Cancer Clinical Trial 2023: Physician's Choice Highlights & Side Effects. Trial Name: NCT05948475 — Phase 3
Physician's Choice 2023 Treatment Timeline for Medical Study. Trial Name: NCT05948475 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open enrollments for this research project?

"According to the clinicaltrials.gov registry, this trial is not presently recruiting patients and has been unchanged since July 7th 2023. Nonetheless, there are 199 different medical studies that require participants at this time."

Answered by AI

Has Tinengotinib 8 mg QD been validated by the U.S Food and Drug Administration?

"Tinengotinib 8 mg QD has been given a safety score of 3 due to the availability of multiple rounds of data that suggest efficacy and support its safety."

Answered by AI

How many healthcare centers are administering this trial?

"The enrolment of this trial involves 14 healthcare sites, including the well-known University of Chicago Hospitals and Medical Center UCMC in Chicago, Roswell Park Comprehensive Cancer Center in Buffalo, and University of Michigan in Morrisville. Additionally there are 11 other centres participating."

Answered by AI

What are the chief goals of this investigation?

"This medical study looks to measure progression-free survival (PFS) over the course of 30 days post-discontinuation. Secondary aims include determining duration of response, overall survival rate, and objective response rate as per RECIST version 1.1 criteria."

Answered by AI

Who else is applying?

What site did they apply to?
Roswell Park Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

Recent research and studies
clinicaltrials.govStudy
Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma
2023. "Study of Tinengotinib VS. Physician's Choice a Treatment of Subjects With FGFR-altered in Cholangiocarcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05948475.
All > Intrahepatic Cholangiocarcinoma > Knoxville
~133 spots leftby May 2026
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