Recruiting
Phase 2

Fruquintinib & FOLFIRI

Sponsor:

SCRI Development Innovations, LLC

Code:

NCT07011576

Conditions

Colon Cancer

Rectal Cancer

Colorectal Cancer

Colorectal Cancer (CRC)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

fruquintinib

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

Study Details

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)

Study ID

NCT07011576

Start date

Sep 29, 2025

Status verified date

Jun, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Key Inclusion Criteria:

  • 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 first-line therapy for mCRC that included oxaliplatin, a fluoropyrimidine, and a BEV-based agent. FOLFOXIRI, BEV, and SOX/BEV regimes are not permitted. A minimum of 2 cycles of first line of therapy must have been completed.
  • 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

Key Exclusion Criteria:

  • 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 prior systemic treatment for mCRC or any prior systemic treatment including FOLFIRI or irinotecan-based therapy.
  • Participants who received oxaliplatin and fluoropyrimidine in the first line neoadjuvant or adjuvant setting (prior to Metastatic diagnosis) and progressed within 6 months are not eligible due to lack of BEV exposure.
  • Uncontrolled, symptomatic brain metastases
  • Uncontrolled, symptomatic gastrointestinal disease
  • Participants 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Fruquinitinib + FOLFIRI

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.

Interventions

fruquintinib

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

FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)

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. The 5-FU Bolus may be omitted starting from Cycle 1 Day 1 at the investigators discretion, specifically in participants with a history of cytopenias or toxicities within the first line of treatment.

Primary outcome measure

  • Progression-Free Survival (PFS) rate at 6 months [ Time Frame: Every 2 cycles from cycle 1 day 1, until disease progression or death, up to 2 years. Each cycle is 28 days. ]

Central Contacts and Locations

Central contacts

Sarah Cannon Sarah Cannon Development Innovations, LLC

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

Locations

Rocky Mountain Cancer Center - Primary

Recruiting

Denver, Colorado, United States, 80218

Illinois Cancer Specialists

Recruiting

Arlington Heights, Illinois, United States, 60005

Maryland Oncology Hematology

Recruiting

Columbia, Maryland, United States, 21044

Minnesota Oncology Hematology - Primary

Recruiting

Maple Grove, Minnesota, United States, 55369

Missouri Cancer Associates

Recruiting

Columbia, Missouri, United States, 65201

Oncology Associates of Oregon - Primary

Recruiting

Eugene, Oregon, United States, 97401

Northwest Cancer Specialists - Compass

Recruiting

Portland, Oregon, United States, 97213

Alliance Cancer Specialists

Recruiting

Wynnewood, Pennsylvania, United States, 19096

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Texas Oncology - Central/South Texas

Recruiting

Austin, Texas, United States, 78705

Texas Oncology - Gulf Coast

Recruiting

Beaumont, Texas, United States, 77702

Texas Oncology - Northeast Texas

Recruiting

Tyler, Texas, United States, 75702

Virginia Oncology Associates

Recruiting

Norfolk, Virginia, United States, 23502

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

Recruiting

Salem, Virginia, United States, 24153

More Information

Sponsor

SCRI Development Innovations, LLC

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by SCRI Development Innovations, LLC on 2026-06-12.