ClinicalTrials.Veeva

Menu

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

HUTCHMED logo

HUTCHMED

Status and phase

Active, not recruiting
Phase 2
Phase 1

Conditions

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

Treatments

Drug: Fruquintinib
Drug: Tislelizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04577963
2020-013-00US3

Details and patient eligibility

About

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)

Enrollment

112 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

112 participants in 2 patient groups

Part 1
Experimental group
Description:
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
Treatment:
Drug: Tislelizumab
Drug: Fruquintinib
Part 2
Experimental group
Description:
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
Treatment:
Drug: Tislelizumab
Drug: Fruquintinib

Trial contacts and locations

16

Loading...

Central trial contact

Keneikia Morgan; Alberto Fernandez

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems