Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Breast Neoplasms

Triple Negative Breast Neoplasms

Endometrial Neoplasms

Breast Diseases

Skin Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Herbal and Botanical

Tislelizumab

Antineoplastic Agents, Immunological

Cola

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

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

Fruquintinib

William Schelman, MD, PhD

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)

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

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

To assess the safety and tolerability by monitoring AEs characterized by type, frequency, severity per NCI-CTCAE v5.0

To confirm the RP2D of fruquintinib in combination with tislelizumab

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

Blood samples will be taken to measure levels of fruquintinib

Blood samples will be taken to measure levels of tislelizumab

To further evaluate efficacy of fruquintinib in combination with tislelizumab in patients with advanced or metastatic TNBC or EC per investigator assessment

To detect the expression biomarkers in tumor tissues of patients

To evaluate the immunogenicity of fruquintinib in combination with tislelizumab

The incidence of complete response, partial response, and stable disease

The incidence of partial response and stable disease

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

The period from date of enrollment to date of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors	NCT04577963	Triple Negative... Endometrial Can... Solid Tumor, Un... Colorectal Canc...	Fruquintinib Tislelizumab	18 Years -	Hutchmed
A Study of Fruquintinib in Combination With Tislelizumab in Advanced Solid Tumors	NCT04577963	Triple Negative... Endometrial Can... Solid Tumor, Un... Colorectal Canc...	Fruquintinib Tislelizumab	18 Years -	Hutchmed

Spots Global Cancer Trial Database for hr negative

Every month we try and update this database with for hr negative cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for hr negative

Every month we try and update this database with for hr negative cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for hr negative cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.