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Fruquintinib for Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Colorectal Cancer+3 MoreFruquintinib - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new cancer drug, fruquintinib, to see if it is safe and effective when used with tislelizumab to treat patients with locally advanced or metastatic solid tumors. The trial will be conducted in two parts; a Safety Lead-in Phase (Part 1) and a Dose Expansion Phase (Part 2). Part 1 will be open to any-comer solid tumors and will determine the Recommended Phase 2 Dose (RP2D). The RP2D will be administered to four cohorts of patients in Part 2.

Eligible Conditions
  • Endometrial Cancer
  • Solid Tumor
  • Colorectal Cancer
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Combination Therapy: PY314 + Pembrolizumab

Study Objectives

3 Primary · 9 Secondary · Reporting Duration: Up to 36 months

Day 28
Adverse Events by type, frequency, and severity
Recommended Phase 2 Dose
Up to 18 months
Changes from baseline in biomarkers
Incidence of ADA to tislelizumab
Plasma
Maximum serum concentrations of tislelizumab with blood sampling
Objective Response Rate
Up to 24 months
Clinical Benefit Rate
Disease Control Rate (DCR)
Duration of Response
Progression-free Survival
Up to 36 months
Overall Survival

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
HMPL-306
1
HMPL-306
1
Combination Therapy: PY314 + Pembrolizumab

Trial Design

2 Treatment Groups

Part 1
1 of 2
Part 2
1 of 2

Experimental Treatment

112 Total Participants · 2 Treatment Groups

Primary Treatment: Fruquintinib · No Placebo Group · Phase 1 & 2

Part 1Experimental Group · 2 Interventions: Tislelizumab, Fruquintinib · Intervention Types: Drug, Drug
Part 2Experimental Group · 2 Interventions: Tislelizumab, Fruquintinib · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tislelizumab
Not yet FDA approved
Fruquintinib
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 36 months

Who is running the clinical trial?

BeiGeneIndustry Sponsor
147 Previous Clinical Trials
26,673 Total Patients Enrolled
Hutchison Medipharma LimitedLead Sponsor
99 Previous Clinical Trials
13,286 Total Patients Enrolled
William Schelman, MD, PhDStudy DirectorHutchison MediPharma International
1 Previous Clinical Trials
691 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are willing and able to provide informed consent.
You have advanced or metastatic, unresectable adenocarcinoma of the colon or rectum.
You have a performance status of 1 or less.
You have at least 1 measurable lesion as defined by RECIST v1.1.1.
Tumor tissue must be available for central laboratory assessment.
References

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