A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors

NCT ID: NCT04577963

Last Updated: 2025-07-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-09
• Study Completion Date: 2024-06-18

Brief Summary

This is an open-label, multi-center, non-randomized, Phase 1b/2 study to assess the safety and efficacy of fruquintinib in combination with tislelizumab in patients with locally advanced or metastatic solid tumors. This study will be conducted in 2 parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2).

The Safety Lead-in Phase, open to any-comer solid tumors, will determine the RP2D. The RP2D will be administered to 3 cohorts of patients in the Dose Expansion Phase.

• Cohort A: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-treated)
• Cohort B: Advanced or Metastatic Triple Negative Breast Cancer (TNBC) (IO-Naïve)
• Cohort C: Advanced or Metastatic Endometrial Cancer (EC) (IO-Naïve)
• Cohort D: Advanced or Metastatic Colorectal Cancer (mCRC) (IO-Naïve)

Conditions

Triple Negative Breast Cancer; Endometrial Cancer; Solid Tumor, Unspecified, Adult; Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part 1

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

Group Type: EXPERIMENTAL

Fruquintinib

Intervention Type: DRUG

Oral VEGFR inhibitor

Tislelizumab

Intervention Type: DRUG

PD-1 inhibitor

Part 2

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 Type: EXPERIMENTAL

Fruquintinib

Intervention Type: DRUG

Oral VEGFR inhibitor

Tislelizumab

Intervention Type: DRUG

PD-1 inhibitor

Interventions

Fruquintinib

Oral VEGFR inhibitor

Intervention Type: DRUG

Tislelizumab

PD-1 inhibitor

Intervention Type: DRUG

Other Intervention Names

HMPL-013; BGB-A317

Eligibility Criteria

Inclusion Criteria

1. Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines;

2. Age ≥18 years;

3. 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.

4. Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.

5. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.

6. At least 1 measurable lesion as defined by RECIST v1.1.

Exclusion Criteria

1. Has at screening any central nervous system metastasis and/or leptomeningeal disease.

2. Except for Cohort A, Prior therapy targeting CTLA-4, PD-1, PD-L1 or programmed cell death protein ligand-2 (PD-L2) or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.

3. Prior treatment with a VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab).

4. Except for Cohort D, prior treatment with an anti-VEGFR antibody (eg, bevacizumab).

5. Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.

6. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

BeiGene

INDUSTRY

Sponsor Role: collaborator

Hutchmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Schelman, MD, PhD

Role: STUDY_DIRECTOR

HUTCHMED International

Locations

Mayo Clinic Arizona

Phoenix, Arizona, United States

Highlands Oncology

Springdale, Arkansas, United States

Beverly Hills Cancer Center

Beverly Hills, California, United States

University of Colorado

Aurora, Colorado, United States

Florida Cancer Specialists - FCS South

Port Charlotte, Florida, United States

Florida Cancer Center North

St. Petersburg, Florida, United States

Florida Cancer Specialists Panhandle

Tallahassee, Florida, United States

Florida Cancer Specialists - East (FCS East)

West Palm Beach, Florida, United States

HOC AON Baton Rouge / Sarah Cannon

Baton Rouge, Louisiana, United States

Messino Cancer Center

Asheville, North Carolina, United States

Oklahoma University Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, United States

Tennessee Oncology-Chattanooga

Chattanooga, Tennessee, United States

Tennesse Oncology

Nashville, Tennessee, United States

Vanderbilt Ingram Cancer Center

Nashville, Tennessee, United States

The University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2020-013-00US3

Identifier Type: -

Identifier Source: org_study_id