A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)

NCT07011576 | Recruiting Phase 2 FDA Drug

• 1 other identifier: GI 387
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 14

Brief Summary

This is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to:

• Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting
• Evaluate the safety of the combination of fruquintinib + FOLFIRI

Conditions

Colon Cancer; Rectal Cancer; Colorectal Cancer; Colorectal Cancer (CRC)

Keywords

Colorectal cancer; Colon Cancer; Rectal cancer; Metastatic colorectal cancer; mCRC; VEGFR inhibitor; Fruquintinib; FOLFIRI; Second line; 2L mCRC

Outcome Measures

Primary Outcomes (1)

• Progression-Free Survival (PFS) rate at 6 months

  Progression-Free Survival (PFS) rate at 6 months, defined as the percentage of participants at 6 months who have not experienced disease progression as defined by the RECIST Version 1.1 criteria or death on study. Participants who are alive and free from disease progression will be censored at the date of last tumor assessment.

  Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.

Secondary Outcomes (5)

• Overall Response Rate (ORR)

  Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.

• Duration of response (DoR)

  Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.

• Disease control response rate (DCR)

  Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days.

• Number of participants with treatment emergent adverse events

  Every 28 day cycle, from signed informed consent to 30 days after treatment discontinuation up to 1 year.

• Overall Survival (OS)

  From cycle 1 day 1 up to 2 years

Study Arms (1)

Fruquinitinib + FOLFIRI

EXPERIMENTAL

Participants will receive an assigned dose level of fruquintinib in combination with FOLFIRI. Cycles will be 28 days, where participants will take fruquinitinib orally on Days 1 through 21 in combination with FOLFIRI intravenous infusion (IV) every 2 weeks. Up to 60 participants will be enrolled.

Drug: fruquintinib; Drug: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Interventions

fruquintinib DRUG

Participants will receive oral fruquintinib, with or without food, for the first 21 days of each 28-day cycle.

Also known as: Fruzaqla

Fruquinitinib + FOLFIRI

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) DRUG

Participants will receive FOLFIRI once every 2 weeks on day 1 of every 28-day cycle (twice in each cycle). The FOLFIRI regimen consists of irinotecan given 180 mg/m2 intravenous infusion (IV), leucovorin 400 mg/m2 (or 200 mg/m2 levoleucovorin) IV, followed by 5-fluorouracil (5-FU) 400 mg/m2 bolus injection and 5-FU continuous IV infusion of 2400 mg/m2 over 46 to 48 hours.

Fruquinitinib + FOLFIRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed mCRC ; histologically documented adenocarcinoma of the colon or rectum with at least one measurable lesion according to RECIST v1.
• Genetic aberrations are allowed, except for microsatellite instability high (MSI-H) and BRAF V600
• Participants must have received FOLFOX (folinic acid, fluorouracil, and oxaliplatin) and Bevacizumab- based first-line therapy for mCRC
• At least 18 years-of-age at the time of signature of the Informed Consent Form (ICF)
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 to 2

You may not qualify if:

• Current treatment with other anticancer treatments within 21 days of the first dose of study treatment
• Major surgery within 4 weeks of the first planned dose of study treatment
• More than one treatment received for mCRC prior to signing the ICFs
• Uncontrolled, symptomatic brain metastases
• Uncontrolled, symptomatic gastrointestinal disease
• Patients with uncontrolled hypertension
• Women who are pregnant, nursing, or plan to become pregnant while in the study and for at least 6 months after the last administration of study chemotherapy
• Men who plan to father a child while in the study and for at least 6 months after the last administration of study chemotherapy
• Documented major electrocardiogram (ECG) abnormalities which are clinically significant.
• Symptomatic or uncontrolled brain metastases, spinal cord compression, or leptomeningeal disease requiring concurrent treatment
• Presence of other active invasive cancers other than the one treated in this study within 5 years prior to screening

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Takeda Development Center Americas, Inc.: collaborator

Study Sites (14)

Rocky Mountain Cancer Center - Primary

Denver, Colorado, 80218, United States

RECRUITING

Illinois Cancer Specialists

Arlington Heights, Illinois, 60005, United States

RECRUITING

Maryland Oncology Hematology

Columbia, Maryland, 21044, United States

RECRUITING

Minnesota Oncology Hematology - Primary

Maple Grove, Minnesota, 55369, United States

RECRUITING

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

RECRUITING

Oncology Associates of Oregon - Primary

Eugene, Oregon, 97401, United States

RECRUITING

Northwest Cancer Specialists - Compass

Portland, Oregon, 97213, United States

RECRUITING

Alliance Cancer Specialists

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, 37203, United States

RECRUITING

Texas Oncology - Central/South Texas

Austin, Texas, 78705, United States

RECRUITING

Texas Oncology - Gulf Coast

Beaumont, Texas, 77702, United States

RECRUITING

Texas Oncology - Northeast Texas

Tyler, Texas, 75702, United States

RECRUITING

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

RECRUITING

Blue Ridge Cancer Care (Oncology & Hematology Associates of Southwest VA)

Salem, Virginia, 24153, United States

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Colorectal Neoplasms

Interventions

HMPL-013; Irinotecan; Fluorouracil; Leucovorin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes

Study Officials

• Meredith Pelster, MD

  SCRI Oncology Partners

  STUDY CHAIR

Central Study Contacts

Sarah Cannon Sarah Cannon Development Innovations, LLC

CONTACT

844-710-6157; SCRI.InnovationsMedical@scri.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 9, 2025
• Study Start: September 29, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

US (14)