Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Participants With Selected 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: NCT04716634
Recruitment Status : Not yet recruiting
First Posted : January 20, 2021
Last Update Posted : January 20, 2021
Sponsor:
Collaborator:
Hutchison Medipharma Limited
Information provided by (Responsible Party):
BeiGene

Brief Summary:
This is an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in participants with advanced or metastatic, unresectable gastric cancer (GC) or colorectal cancer (CRC). The study will be conducted in 2 parts. Part 1 will be the safety run-in stage to determine dose-limiting toxicity (DLT) and recommended Phase 2 dose (RP2D). Part 2 will assess the preliminary efficacy of tislelizumab in combination with fruquintinib in participants as measured by the overall response rate (ORR) and other efficacy and safety profiles.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Tislelizumab Drug: Fruquintinib Phase 2

Detailed Description:

This is an open label, multicenter, Phase 2 study designed to assess the efficacy and safety of tislelizumab in combination with fruquintinib in patients with advanced or metastatic, unresectable GC and CRC. The study will be conducted in 2 parts.

Part 1 of the study will be the safety run-in stage which assesses dose-limiting toxicities (DLTs) and RP2D. Part 2 will begin at RP2D. Patients enrolled in Part 1 at RP2D will be counted towards Part 2; up to approximately 30 patients per cohort will be enrolled at RP2D.

The primary outcome measure of the study is ORR as assessed by the investigator per RECIST v1.1. Tislelizumab and fruquintinib will be administered until disease progression, intolerable toxicity, death, withdrawal of consent or until the study terminates.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of Tislelizumab in Combination With Fruquintinib in Patients With Selected Solid Tumors
Estimated Study Start Date : March 15, 2021
Estimated Primary Completion Date : February 15, 2023
Estimated Study Completion Date : August 15, 2023

Arm Intervention/treatment
Experimental: Tislelizumab + Fruquintinib
Participants with one of the tumors will be enrolled: GC and CRC
Drug: Tislelizumab
Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD 1.
Other Name: BGB-A317

Drug: Fruquintinib
Fruquintinib is a potent, oral VEGFR tyrosine kinase inhibitor (TKI)
Other Name: HMPL-013




Primary Outcome Measures :
  1. Part 1 - Adverse Event (AE) [ Time Frame: Up to 28 Days in Part 1 ]
    Assessed per NCI-CTCAE v5.0

  2. Part 1 - RP2D Of Fruquintinib In Combination With Tislelizumab [ Time Frame: Up to 28 Days in Part 1 ]
  3. Part 2 - Objective Response Rate (ORR) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1


Secondary Outcome Measures :
  1. Part 2 - Progression-Free Survival (PFS) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1

  2. Part 2 - Disease Control Rate (DCR) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1

  3. Part 2 - Clinical Benefit Rate (CBR) [ Time Frame: through study completion, an average of 3 years ]
    Assessed per RECIST v1.1

  4. Part 2 - Duration Of Response (DOR) [ Time Frame: through study completion, an average of 3 years ]
  5. Part 2 - Overall Survival (OS) [ Time Frame: through study completion, an average of 3 years ]
  6. Part 2 - Adverse Event [ Time Frame: through study completion, an average of 3 years ]
    Assessed per NCI-CTCAE v5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. Signed informed consent form (ICF) and able to comply with study requirements.
  2. At least 1 measurable lesion as defined by RECIST v1.1.
  3. Tumor tissue (archival tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment of MSS status (MSI test) for the CRC cohort during the screening period, and for retrospective analysis of other exploratory biomarkers related to response and resistance for the CRC and GC cohorts in a BeiGene designated central or test laboratory.
  4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1
  5. Histologically or cytologically confirmed, advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction; and histologically or cytologically confirmed, advanced or metastatic, unresectable adenocarcinoma of the colon or rectum.

Key Exclusion Criteria:

  1. Has at screening any central nervous system metastasis and/or leptomeningeal disease.
  2. 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 VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab).
  4. Received more than 1 line of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of gastric or esophagogastric junction, or more than 2 lines of systemic treatment for advanced or metastatic, unresectable adenocarcinoma of the colon or rectum.
  5. 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): NCT04716634


Contacts
Layout table for location contacts
Contact: BeiGene 1-877-828-5568 clinicaltrials@beigene.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Korea, Republic of
Asan Medical Center
Seoul, Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
BeiGene
Hutchison Medipharma Limited
Investigators
Layout table for investigator information
Study Director: Jian Li BeiGene
Layout table for additonal information
Responsible Party: BeiGene
ClinicalTrials.gov Identifier: NCT04716634    
Other Study ID Numbers: BGB-A317-fruquintinib-201
First Posted: January 20, 2021    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by BeiGene:
Solid tumors
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasms