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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04577963
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : November 14, 2022
Sponsor:
Collaborator:
BeiGene
Information provided by (Responsible Party):
Hutchmed ( Hutchison Medipharma Limited )

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)

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Endometrial Cancer Solid Tumor, Unspecified, Adult Colorectal Cancer Drug: Fruquintinib Drug: Tislelizumab Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Phase 1b/2 Study to Evaluate the Safety and Efficacy of Fruquintinib in Combination With Tislelizumab in Patients With Advanced Solid Tumors
Actual Study Start Date : August 9, 2021
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
Drug: Fruquintinib
Oral VEGFR inhibitor
Other Name: HMPL-013

Drug: Tislelizumab
PD-1 inhibitor
Other Name: BGB-A317

Experimental: 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
Drug: Fruquintinib
Oral VEGFR inhibitor
Other Name: HMPL-013

Drug: Tislelizumab
PD-1 inhibitor
Other Name: BGB-A317




Primary Outcome Measures :
  1. Adverse Events by type, frequency, and severity [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    To assess the safety and tolerability by monitoring AEs characterized by type, frequency, severity per NCI-CTCAE v5.0

  2. Recommended Phase 2 Dose [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]
    To confirm the RP2D of fruquintinib in combination with tislelizumab

  3. Objective Response Rate [ Time Frame: Up to 18 months ]
    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


Secondary Outcome Measures :
  1. Maximum plasma concentrations of fruquintinib with blood sampling [ Time Frame: Up to 18 months ]
    Blood samples will be taken to measure levels of fruquintinib

  2. Maximum serum concentrations of tislelizumab with blood sampling [ Time Frame: Up to 18 months ]
    Blood samples will be taken to measure levels of tislelizumab

  3. Progression-free Survival [ Time Frame: Up to 24 months ]
    To further evaluate efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic TNBC or EC per investigator assessment

  4. Changes from baseline in biomarkers [ Time Frame: Up to 18 months ]
    To detect the expression biomarkers in tumor tissues of patients

  5. Incidence of ADA to tislelizumab [ Time Frame: Up to 18 months ]
    To evaluate the immunogenicity of fruquintinib in combination with tislelizumab

  6. Disease Control Rate (DCR) [ Time Frame: Up to 24 months ]
    The incidence of complete response, partial response, and stable disease

  7. Clinical Benefit Rate [ Time Frame: Up to 24 months ]
    The incidence of partial response and stable disease

  8. Duration of Response [ Time Frame: Up to 24 months ]
    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

  9. Overall Survival [ Time Frame: Up to 36 months ]
    The period from date of enrollment to date of death



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04577963


Contacts
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Contact: Alberto Fernandez 973-567-3891 albertof@hutch-med.com
Contact: Keneikia Morgan keneikiam@hutch-med.com

Locations
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United States, Arizona
Mayo Clinic Arizona Recruiting
Phoenix, Arizona, United States, 85054
Contact    855-776-0015      
United States, Arkansas
Highlands Oncology Recruiting
Springdale, Arkansas, United States, 72762
Contact: H Holtzen       HHoltzen@hogonc.com   
Principal Investigator: Thaddeus Beck, MD         
United States, California
Beverly Hills Cancer Center Recruiting
Beverly Hills, California, United States, 90211
Contact: Ali Muhammas       AMuhammad@bhcancercenter.com   
Principal Investigator: Linnea Chap, MD         
United States, Colorado
University of Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: J Diamond       MARK.MORROW@CUANSCHUTZ.EDU   
Principal Investigator: Jennifer Diamond, MD         
United States, Florida
Florida Cancer Specialists - FCS South Recruiting
Port Charlotte, Florida, United States, 33980
Contact: V Wright-Browne       browne@flcancer.com   
Principal Investigator: Vance Wright-Browne, MD         
Florida Cancer Center North Recruiting
Saint Petersburg, Florida, United States, 33709
Contact: G Wright         
Principal Investigator: Gail Wright, MD         
Florida Cancer Specialists Panhandle Recruiting
Tallahassee, Florida, United States, 32308
Contact: V Bhanderi       vbhanderi@flcancer.com   
Principal Investigator: Pareshkumar Patel, MD         
Florida Cancer Specialists - East (FCS East) Recruiting
West Palm Beach, Florida, United States, 33401
Contact: E Harris         
Principal Investigator: Eric Harris, MD         
United States, Louisiana
HOC AON Baton Rouge / Sarah Cannon Recruiting
Baton Rouge, Louisiana, United States, 70809
Contact: M Castine       mcastine@gmail.com   
Principal Investigator: Michael Castine, MD         
United States, North Carolina
Messino Cancer Center Recruiting
Asheville, North Carolina, United States, 28806
Contact: C Chay         
Principal Investigator: Christopher Chay, MD         
United States, Oklahoma
Oklahoma University Stephenson Cancer Center Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Susanna Ulahannan, MD         
Principal Investigator: Susanna Ulahannan         
United States, Rhode Island
Women and Infants Hospital of Rhode Island Recruiting
Providence, Rhode Island, United States, 02905
Contact: Cara Mathews, MD         
Principal Investigator: Cara Mathews         
United States, Tennessee
Tennessee Oncology-Chattanooga Recruiting
Chattanooga, Tennessee, United States, 37404
Contact: B Daniel       Nicole.Shoviak@SarahCannon.com   
Principal Investigator: Brooke Daniel, MD         
Tennesse Oncology Recruiting
Nashville, Tennessee, United States, 37203
Contact: E Hamilton         
Principal Investigator: Erika Hamilton, MD         
Vanderbilt Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Cathy Eng, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: H Garber       dtripathy@mdanderson.org   
Principal Investigator: Haven Garber, MD         
Sponsors and Collaborators
Hutchison Medipharma Limited
BeiGene
Investigators
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Study Director: William Schelman, MD, PhD Hutchison MediPharma International
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Responsible Party: Hutchison Medipharma Limited
ClinicalTrials.gov Identifier: NCT04577963    
Other Study ID Numbers: 2020-013-00US3
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hutchmed ( Hutchison Medipharma Limited ):
Breast cancer
Triple negative
Her2-
HR-
ER-
PR-
Her2 negative
HR negative
ER negative
PR negative
TNBC
VEGF
VEGFR
Endometrial cancer
Colon
Rectal
mCRC
Colorectal
Additional relevant MeSH terms:
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Endometrial Neoplasms
Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases