Triple Negative Breast CancerPhase 1/2NCT04577963
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors
A Phase 1/2 study testing Fruquintinib and Tislelizumab in people with Triple Negative Breast Cancer and Endometrial Cancer, run by Hutchmed at 16 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Triple Negative Breast Cancer, Endometrial Cancer, Solid Tumor, Unspecified, Adult
- What is being tested?
- Fruquintinib and Tislelizumab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 16 sitesUnited States
- Study dates
- 9 Aug 2021to 18 Jun 2024
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines;
- Age ≥18 years;
- 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.
- Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
- At least 1 measurable lesion as defined by RECIST v1.1.
Who cannot join
- Has at screening any central nervous system metastasis and/or leptomeningeal disease.
- 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.
- Prior treatment with a VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab).
- Except for Cohort D, prior treatment with an anti-VEGFR antibody (eg, bevacizumab).
- Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
- 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
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
Messino Cancer Center
Asheville, North Carolina, 28806
University of Colorado
Aurora, Colorado, 80045
HOC AON Baton Rouge / Sarah Cannon
Baton Rouge, Louisiana, 70809
Beverly Hills Cancer Center
Beverly Hills, California, 90211
Tennessee Oncology-Chattanooga
Chattanooga, Tennessee, 37404
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Tennesse Oncology
Nashville, Tennessee, 37203
Vanderbilt Ingram Cancer Center
Nashville, Tennessee, 37232
Oklahoma University Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Florida Cancer Specialists - FCS South
Port Charlotte, Florida, 33980
Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905
Highlands Oncology
Springdale, Arkansas, 72762
Florida Cancer Center North
St. Petersburg, Florida, 33709
Florida Cancer Specialists Panhandle
Tallahassee, Florida, 32308
Florida Cancer Specialists - East (FCS East)
West Palm Beach, Florida, 33401
About this study
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
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
- Being tested
- Fruquintinib, Tislelizumab
- Keywords
- 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
- Medical subject headings
- Triple Negative Breast Neoplasms, Endometrial Neoplasms, Colorectal Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FruquintinibDrug
Also called HMPL-013
Oral VEGFR inhibitor
TislelizumabDrug
Also called BGB-A317
PD-1 inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Part 1 | Experimental | 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 Receives: Drug: Fruquintinib; Drug: Tislelizumab |
| Part 2 | Experimental | 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 Receives: Drug: Fruquintinib; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Number of Patients With Dose-Limiting Toxicities (DLTs)
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) v5.0, DLT was defined as any 1 of following toxicities during DLT assessment window and considered by Investigator to be related to 1 or more study treatments:a)Hematologic: grade(G) 4 neutropenia lasting >7 days, G ≥3 febrile neutropenia, G 3 thrombocytopenia with clinically significant bleeding, G 4 thrombocytopenia, G ≥4 anemia.b) Non-hematologic:all G ≥3 non-hematologic toxicities except:G 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolved to G ≤1 within 7 days, G 3 nausea/vomiting or diarrhea for <72 hours with antiemetic and supportive care, G 3 fatigue for <1 week, G ≥3 electrolyte abnormality lasting up to 72 hours and resolving with treatment, G 3 rash returning to baseline or G ≤1 within 7 days with treatment,G ≥3 amylase or lipase elevation without symptoms of pancreatitis,G 3 hypertension returning to baseline or G≤1 within 7 days with treatment.
Measured: From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)
Part 1: Recommended Phase 2 Dose (RP2D) of Fruquintinib in Combination With Tislelizumab
The RP2D of fruquintinib in combination with tislelizumab based on the safety and tolerability assessments in Part 1 patients.
Measured: From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)
Part 2: Objective Response Rate (ORR)
The ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Secondary outcomes (11)
Part 1: Objective Response Rate
The ORR was defined as the percentage of patients with a confirmed BOR of CR or PR as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
Measured: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Progression-free Survival (PFS)
PFS was defined as the time from the start of study treatment until the first radiographic documentation of objective progression as assessed by the investigator using RECIST v1.1, or death from any cause. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.
Measured: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Disease Control Rate (DCR)
The DCR was defined as the percentage of patients with a BOR of CR, PR, or stable disease (SD) lasting for at least 7 weeks as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Measured: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Clinical Benefit Rate (CBR)
The CBR was defined as the percentage of patients with a BOR of CR, PR, or durable SD (i.e., lasting for at least 6 months) as determined by the investigator using RECIST v1.1. Durable SD was SD for at least 6 months. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Measured: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Duration of Response (DoR)
The DoR was defined as the time from the first occurrence of PR or CR by RECIST v1.1, whichever came first until PD or death. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 mm. The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. The PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum also demonstrated an absolute increase of at least 5 mm. The appearance of 1 or more new lesions was also considered progression.
Measured: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Overall Survival (OS)
The OS was defined as the time from start of study treatment until the date of death due to any cause.
Measured: From the first dose of study treatment (Day 1) up to date of death due to any cause, up to a maximum of approximately 34 months
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Blood samples were collected at the specified timepoints to determine plasma concentrations of fruquintinib and metabolite M11.
Measured: Pre-dose on Days 1, 8, 15, 21 of Cycle 1 and on Day 1 of Cycles 2, 4, 7, 13; 2 to 4 hours post-dose on Days 1 and 21 of Cycle 1 (cycle duration: 4 weeks)
Parts 1 and 2: Serum Concentrations of Tislelizumab
Blood samples were collected at the specified timepoints to determine serum concentrations of tislelizumab.
Measured: Pre-infusion on Day 1 of Cycles 1, 2, 4, 7, 13; at end of infusion on Day 1 of Cycles 1 and 4; on Days 8, 15, and 21 of Cycle 1 (cycle duration: 4 weeks)
Parts 1 and 2: Number of Patients With Antidrug Antibodies (ADAs) to Tislelizumab
Blood samples were collected at the specified timepoints to detect ADAs to tislelizumab. Treatment-induced ADA was defined as ADA negative at baseline and ADA positive post-baseline. Treatment-boosted ADA was defined as ADA positive at baseline that was boosted to a 4-fold or higher-level following treatment administration.
Measured: From the first dose of study treatment (Day 1) up to end of treatment, up to approximately 17 months for Part 1 and 20 months for Part 2
Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
An AE was any untoward medical occurrence in a clinical study patient temporally associated with the use of a study treatment, whether or not considered related to the treatment. An AE was considered "serious" if, in the view of either the investigator or sponsor, it resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, was a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, was an abnormal pregnancy outcome in a child born to a female patient/female partner of a male patient exposed to study treatment or was an important medical event. TEAEs were AEs that started or worsened in severity on or after the first dose of study treatment and up to 30 days after the date of last study treatment administration.
Measured: From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 21 months
Part 2: Change From Baseline in Programmed Death-Ligand 1 (PD-L1) Expression
Expression of PD-L1 biomarker was planned to be assessed in tumor tissues of the patients. Baseline was defined as the last non-missing assessment prior to the first administration of any study treatment (whichever occurred first), including scheduled and unscheduled visits, unless otherwise specified.
Measured: Baseline (Day 1) up to end of treatment, up to approximately 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start9 Aug 2021
- Primary completion18 Jun 2024
- Study completion18 Jun 2024
Why it stopped: At the time of study termination, both fruquintinib and tislelizumab are commercially available in the United States.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Triple Negative Breast CancerStudies of the same condition, open and under way.
- More trials run by HutchmedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04577963
- Sponsor's protocol ID
- 2020-013-00US3
- Status last verified
- Jul 2025
- First submitted
- 23 Sep 2020
- Last updated
- 14 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04577963
- Acronym / sponsor ID
- 2020-013-00US3
- Conditions
- Triple Negative Breast Cancer, Endometrial Cancer, Solid Tumor, Unspecified, Adult, Colorectal Cancer
- Keywords
- Breast cancer, Triple negative, Her2-, HR-, ER-, PR-, Her2 negative, HR negative
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: At the time of study termination, both fruquintinib and tislelizumab are commercially available in the United States.
- Enrolment
- 52 participants (actual)
- Lead sponsor
- HutchmedIndustry (pharma, biotech, devices)
- Collaborators
- BeiGene
- Study start
- 9 Aug 2021 (actual)
- Primary completion
- 18 Jun 2024 (actual)
- Study completion
- 18 Jun 2024 (actual)
- First posted
- 8 Oct 2020 (actual)
- Results
- Posted 14 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Part 1 | Experimental | Drug: Fruquintinib, Drug: TislelizumabApproximately 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 |
| Part 2 | Experimental | Drug: Fruquintinib, Drug: TislelizumabPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide informed consent signed by study patient or legally acceptable representative, as specified by health authorities and institutional guidelines;
- Age ≥18 years;
- 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.
- Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
Key exclusion criteria (7 listed)
- Has at screening any central nervous system metastasis and/or leptomeningeal disease.
- 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.
- Prior treatment with a VEGFR-TKI or anti-VEGFR antibody (eg, ramucirumab).
- Except for Cohort D, prior treatment with an anti-VEGFR antibody (eg, bevacizumab).
- Tumor tissue (archival or fresh tumor tissues as formalin-fixed paraffin-embedded blocks or approximately 15 unstained slides) for central laboratory assessment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FruquintinibAlso: HMPL-013Oral VEGFR inhibitor | Drug | Part 1, Part 2 |
| TislelizumabAlso: BGB-A317PD-1 inhibitor | Drug | Part 1, Part 2 |
Primary outcome
Part 1: Number of Patients With Dose-Limiting Toxicities (DLTs)
Time frame: From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)
According to National Cancer Institute Common Terminology Criteria for Adverse Events(AEs) v5.0, DLT was defined as any 1 of following toxicities during DLT assessment window and considered by Investigator to be related to 1 or more study treatments:a)Hematologic: grade(G) 4 neutropenia lasting >7 days, G ≥3 febrile neutropenia, G 3 thrombocytopenia with clinically significant bleeding, G 4 thrombocytopenia, G ≥4 anemia.b) Non-hematologic:all G ≥3 non-hematologic toxicities except:G 3 endocrinopathy controlled by hormonal replacement with no hospitalization and resolved to G ≤1 within 7 days, G 3 nausea/vomiting or diarrhea for <72 hours with antiemetic and supportive care, G 3 fatigue for <1 week, G ≥3 electrolyte abnormality lasting up to 72 hours and resolving with treatment, G 3 rash returning to baseline or G ≤1 within 7 days with treatment,G ≥3 amylase or lipase elevation without symptoms of pancreatitis,G 3 hypertension returning to baseline or G≤1 within 7 days with treatment.
Part 1: Recommended Phase 2 Dose (RP2D) of Fruquintinib in Combination With Tislelizumab
Time frame: From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)
The RP2D of fruquintinib in combination with tislelizumab based on the safety and tolerability assessments in Part 1 patients.
Part 2: Objective Response Rate (ORR)
Time frame: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
The ORR was defined as the percentage of patients with a confirmed best overall response (BOR) of complete response (CR) or partial response (PR) as determined by the investigator using RECIST v1.1. The BOR was defined as the best response recorded from the start of study treatment until documented RECIST v1.1 progression or the start date of new anticancer therapy, whichever came first. The CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had a reduction in short axis to <10 millimeters (mm). The PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.
11 secondary outcomes
Part 1: Objective Response Rate
Time frame: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Progression-free Survival (PFS)
Time frame: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Disease Control Rate (DCR)
Time frame: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Clinical Benefit Rate (CBR)
Time frame: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Duration of Response (DoR)
Time frame: Tumor assessments performed every 8 weeks (+/-1 week) until PD, up to a maximum of approximately 34 months
Parts 1 and 2: Overall Survival (OS)
Time frame: From the first dose of study treatment (Day 1) up to date of death due to any cause, up to a maximum of approximately 34 months
Parts 1 and 2: Plasma Concentrations of Fruquintinib and Metabolite M11
Time frame: Pre-dose on Days 1, 8, 15, 21 of Cycle 1 and on Day 1 of Cycles 2, 4, 7, 13; 2 to 4 hours post-dose on Days 1 and 21 of Cycle 1 (cycle duration: 4 weeks)
Parts 1 and 2: Serum Concentrations of Tislelizumab
Time frame: Pre-infusion on Day 1 of Cycles 1, 2, 4, 7, 13; at end of infusion on Day 1 of Cycles 1 and 4; on Days 8, 15, and 21 of Cycle 1 (cycle duration: 4 weeks)
Parts 1 and 2: Number of Patients With Antidrug Antibodies (ADAs) to Tislelizumab
Time frame: From the first dose of study treatment (Day 1) up to end of treatment, up to approximately 17 months for Part 1 and 20 months for Part 2
Part 2: Number of Patients With Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and TEAEs Leading to Treatment Discontinuation
Time frame: From the first dose of study treatment (Day 1) up to 30 days after the last dose of study treatment, approximately 21 months
Part 2: Change From Baseline in Programmed Death-Ligand 1 (PD-L1) Expression
Time frame: Baseline (Day 1) up to end of treatment, up to approximately 20 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Triple Negative Breast Cancer
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 2
BrAin Metastasis in tripLe Negateive Breast Cancer: IvoneScimab and Trop2 ADC
Triple-Negative Breast Cancer (TNBC), Brain Metastases
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Schelman, MD, PhD study director
HUTCHMED International
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Fruquintinib and Tislelizumab in people with Triple Negative Breast Cancer and Endometrial Cancer, run by Hutchmed at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part 1: Number of Patients With Dose-Limiting Toxicities (DLTs) (time frame: From the first dose of study treatment (Day 1) up to Day 28 of Cycle 1 (cycle duration: 4 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.