← Back to Search

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

No Placebo-Only Group

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.

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).

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

Select...

I am fully active or can carry out light work.

Select...

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:

Select...

I do not have active or a history of serious autoimmune or uncontrolled lung diseases.

Select...

My cancer has spread to my brain or spinal cord.

Select...

I have been treated with a VEGFR inhibitor before.

Select...

I have not received treatments like bevacizumab, except if I'm in Cohort D.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

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

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

Primary study objectives

Adverse Events by type, frequency, and severity

Objective Response Rate

Recommended Phase 2 Dose

Secondary study objectives

Changes from baseline in biomarkers

Clinical Benefit Rate

Disease Control Rate (DCR)

+6 more

Awards & Highlights

No Placebo-Only Group

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

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

0 / 6Eligibility criteria met