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Tyrosine Kinase Inhibitor

Fruquintinib + Tislelizumab for Solid Cancers

Phase 1 & 2
Waitlist Available
Research Sponsored by Hutchison Medipharma Limited
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 ≤1
Histologically or cytologically documented, advanced or metastatic Triple Negative Breast Cancer, histologically or cytologically documented, advanced or metastatic endometrial carcinoma, histologically or cytologically confirmed advanced or metastatic, unresectable adenocarcinoma of the colon or rectum
Must not have
Active autoimmune diseases or history of autoimmune diseases that may relapse, or history of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including but not limited to pulmonary fibrosis, acute lung diseases, etc
Has at screening any central nervous system metastasis and/or leptomeningeal disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Summary

This trial is testing a new cancer drug, fruquintinib, to see if it is safe and effective when used with tislelizumab to treat patients with locally advanced or metastatic solid tumors. The trial will be conducted in two parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2). Part 1 will be open to any-comer solid tumors and will determine the Recommended Phase 2 Dose (RP2D). The RP2D will be administered to four cohorts of patients in Part 2.

Who is the study for?
This trial is for adults with certain advanced solid tumors, including triple negative breast cancer, endometrial carcinoma, and colorectal cancer. Participants must have a performance status indicating they are relatively active and able to care for themselves. They should not have autoimmune diseases or serious lung conditions, nor should they have received certain prior treatments targeting immune checkpoints or blood vessel growth.Check my eligibility
What is being tested?
The study tests the combination of Fruquintinib, a drug that targets blood vessel growth in tumors, with Tislelizumab, an immunotherapy drug. It's conducted in two parts: first to find the right dose (Safety Lead-in Phase) and then to see how well it works at that dose in different groups of patients (Dose Expansion Phase).See study design
What are the potential side effects?
Potential side effects may include typical reactions from immunotherapies like fatigue, skin reactions or inflammation within organs as well as those related to drugs affecting blood vessels such as high blood pressure or bleeding.

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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My cancer is advanced and cannot be surgically removed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have active or a history of serious autoimmune or uncontrolled lung diseases.
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My cancer has spread to my brain or spinal cord.
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I have been treated with a VEGFR inhibitor before.
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I have not received treatments like bevacizumab, except if I'm in Cohort D.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 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
Adverse Events by type, frequency, and severity
Objective Response Rate
Recommended Phase 2 Dose
Secondary outcome measures
Changes from baseline in biomarkers
Clinical Benefit Rate
Disease Control Rate (DCR)
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2Experimental Treatment2 Interventions
Patients will be enrolled to one of the following expansion cohorts: Cohort A: TNBC (immuno-oncology [IO]-treated in the metastatic setting) Cohort B: TNBC (IO-Naïve in the metastatic setting) Cohort C: EC Cohort D: MSS CRC
Group II: Part 1Experimental Treatment2 Interventions
Approximately 6-12 patients with locally advanced or metastatic solid tumors will be enrolled to receive fruquintinib in combination with tislelizumab and assessed for DLTs during the 28-day DLT observation period
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
Not yet FDA approved
Fruquintinib
Not yet FDA approved

Find a Location

Who is running the clinical trial?

BeiGeneIndustry Sponsor
178 Previous Clinical Trials
28,808 Total Patients Enrolled
Hutchison Medipharma LimitedLead Sponsor
101 Previous Clinical Trials
13,487 Total Patients Enrolled
William Schelman, MD, PhDStudy DirectorHutchison MediPharma International
2 Previous Clinical Trials
739 Total Patients Enrolled

Media Library

Fruquintinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04577963 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Part 1, Part 2
Colorectal Cancer Clinical Trial 2023: Fruquintinib Highlights & Side Effects. Trial Name: NCT04577963 — Phase 1 & 2
Fruquintinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04577963 — Phase 1 & 2
~29 spots leftby Jul 2025
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