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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04577963
Other study ID # 2020-013-00US3
Secondary ID
Status Active, not recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date August 9, 2021
Est. completion date November 2024

Study information

Verified date February 2024
Source Hutchmed
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 112
Est. completion date November 2024
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Design


Intervention

Drug:
Fruquintinib
Oral VEGFR inhibitor
Tislelizumab
PD-1 inhibitor

Locations

Country Name City State
United States Messino Cancer Center Asheville North Carolina
United States University of Colorado Aurora Colorado
United States HOC AON Baton Rouge / Sarah Cannon Baton Rouge Louisiana
United States Beverly Hills Cancer Center Beverly Hills California
United States Tennessee Oncology-Chattanooga Chattanooga Tennessee
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Tennesse Oncology Nashville Tennessee
United States Vanderbilt Ingram Cancer Center Nashville Tennessee
United States Oklahoma University Stephenson Cancer Center Oklahoma City Oklahoma
United States Mayo Clinic Arizona Phoenix Arizona
United States Florida Cancer Specialists - FCS South Port Charlotte Florida
United States Women and Infants Hospital of Rhode Island Providence Rhode Island
United States Florida Cancer Center North Saint Petersburg Florida
United States Highlands Oncology Springdale Arkansas
United States Florida Cancer Specialists Panhandle Tallahassee Florida
United States Florida Cancer Specialists - East (FCS East) West Palm Beach Florida

Sponsors (2)

Lead Sponsor Collaborator
Hutchison Medipharma Limited BeiGene

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse Events by type, frequency, and severity To assess the safety and tolerability by monitoring AEs characterized by type, frequency, severity per NCI-CTCAE v5.0 At the end of Cycle 1 (each cycle is 28 days)
Primary Recommended Phase 2 Dose To confirm the RP2D of fruquintinib in combination with tislelizumab At the end of Cycle 1 (each cycle is 28 days)
Primary Objective Response Rate To evaluate the objective response rate (ORR) as assessed by the investigator in subjects with advanced or metastatic TNBC or EC or CRC when treated with fruquintinib in combination with tislelizumab Up to 18 months
Secondary Maximum plasma concentrations of fruquintinib with blood sampling Blood samples will be taken to measure levels of fruquintinib Up to 18 months
Secondary Maximum serum concentrations of tislelizumab with blood sampling Blood samples will be taken to measure levels of tislelizumab Up to 18 months
Secondary Progression-free Survival To further evaluate efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic TNBC or EC per investigator assessment Up to 24 months
Secondary Changes from baseline in biomarkers To detect the expression biomarkers in tumor tissues of patients Up to 18 months
Secondary Incidence of ADA to tislelizumab To evaluate the immunogenicity of fruquintinib in combination with tislelizumab Up to 18 months
Secondary Disease Control Rate (DCR) The incidence of complete response, partial response, and stable disease Up to 24 months
Secondary Clinical Benefit Rate The incidence of partial response and stable disease Up to 24 months
Secondary Duration of Response he duration between the date the criteria for complete response or partial response was first measured (first record shall prevail) and the date of disease recurrence or progression as objectively recroded Up to 24 months
Secondary Overall Survival The period from date of enrollment to date of death Up to 36 months
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