Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer

NCT07662031 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 26-x148
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label Phase 2 study to evaluate the safety and efficacy of Tovecimig combined with FOLFIRI in patients who have received one prior line of therapy for advanced or metastatic colorectal cancer (CRC).

Conditions

Colorectal Cancer; Metastatic Colorectal Cancer

Keywords

Tovecimig; Colorectal cancer; Microsatellite stable

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (ORR)

  Defined as the proportion of patients who have a partial response (PR) or complete response (CR) per RECIST 1.1. CR is defined as disappearance of all target lesions and disappearance of all non-target lesions and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

  Start of treatment to completion of treatment (estimated time up to 12 months)

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  Start of treatment to date of progression or death whichever is earlier (estimated time to be up to 36 months)

• Overall Survival (OS)

  Start of treatment to date of death (estimated time to be up to 36 months)

• Number and types of adverse events (AEs)

  Start of treatment to 30 days after completion of treatment (estimated total time to be 13 months)

• Disease Control Rate (DCR)

  Time of best response through completion of follow-up (estimated total time to be up to 36 months)

• Change in quality of life as measured by Eastern Cooperative Oncology Group (ECOG) performance status

  Baseline to end of treatment (total estimated time 12 months)

Study Arms (1)

Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)

EXPERIMENTAL

Treatment will be administered in 28-day cycles. On Day 1 and 15 of each cycle, patients will receive Tovecimig followed by the FOLFIRI regimen.

Biological: Tovecimig; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-Fluorouracil (5-FU)

Interventions

Tovecimig BIOLOGICAL

Tovecimig is provided in 10 mg/kg dose intravenously over the course of 60 minutes on Day 1 and Day 15 of a 28-day cycle.

Also known as: CTX-009

Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)

Irinotecan DRUG

Standard of care irinotecan will be given at a dose of 180 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen.

Also known as: Camptosar

Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)

Leucovorin DRUG

Standard of care leucovorin will be given at a dose of 400 mg/m\^2 intravenously on Day 1 and Day 15 of each 28-day cycle as part of the FOLFIRI treatment regimen.

Also known as: Vykoura

Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)

5-Fluorouracil (5-FU) DRUG

Standard of care 5-FU will be given at a dose of 2400 mg/m\^2 in continuous infusion over 46 hours on Days 1-2 and Days 15-16 of each 28-day cycle as part of the FOLFIRI treatment regimen.

Also known as: Adrucil, 5-FU

Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed CRC.
• Patient must have undergone resection of his/her primary tumor either as part of treatment for early stage disease with subsequent metastatic progression or due to a tumor related complication in the metastatic setting (e.g. bowel obstruction).
• Measurable disease per RECIST 1.1.
• Patient must have advanced or metastatic disease, and have progressed on one line of standard of care therapy in the advanced/metastatic setting
• At least 18 years of age.
• ECOG performance status ≤ 2
• Adequate bone marrow and organ function as defined below:
• Absolute neutrophil count ≥ 1.5 K/cumm
• Platelets ≥ 100 K/cumm
• Hemoglobin ≥ 8.0 g/dL
• Total bilirubin ≤ 1.5 x IULN or ≤ 2.0 mg/dL in presence of liver metastases
• AST(SGOT)/ALT(SGPT) ≤ 3x IULN or ≤ 5x IULN in presence of liver metastases
• Creatinine clearance \> 50 mL/min by Cockcroft-Gault
• The effects of Tovecimig and FOLFIRI on the developing human fetus are unknown. For this reason, women of childbearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months after the last dose of Tovecimig or any component of FOLFIRI. Should a woman become pregnant or suspect she is pregnant while participating in this study or should a man suspect he has fathered a child, s/he must inform her treating physician immediately.
• Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants.

You may not qualify if:

• Patients with MSI-H status.
• Intact primary tumor that has not been resected.
• More than one line of prior therapy for advanced or metastatic CRC.
• \*If FOLFIRI/FOLFOXIRI was given in the first line, it must have been completed ≥ 6 months before study start date.
• Surgery or major procedure, or systemic anticancer therapy within 4 weeks prior to C1D1.
• Radiation therapy within 2 weeks prior to C1D1.
• Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.
• Receipt of any other investigational agents within 4 weeks prior to C1D1, with exception of investigational imaging agents.
• Patients with untreated brain metastases. Patients with treated brain metastases are allowed if post-treatment brain-imaging after CNS-directed therapy shows no evidence of progression.
• Prior history of diseases/conditions that elevates the patient's risk of hemorrhage, such as a bleeding diatheses, history of prior bowel perforation, or clinically significant active bleeding (i.e. hemoptysis larger than a tablespoon within 3 weeks prior to C1D1).
• Recent history of paracentesis (within 3 weeks prior to C1D1) or current indwelling catheter.
• A history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to Tovecimig (i.e. humanized/human monoclonal antibody drugs), FOFLIRI, or other agents used in the study.
• Use of anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylaxis) purpose within 10 days of C1D1.
• Use of aspirin, other NSAIDs (i.e. naproxen, ibuprofen), or other antiplatelet drugs within 10 days of C1D1.
• Uncontrolled intercurrent illness/infection requiring ongoing systemic antibiotics, antivirus drugs, or other uncontrolled active acute infectious diseases.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Compass Therapeutics: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Irinotecan; Leucovorin; Fluorouracil

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

Study Officials

• Olivia Aranha, MD, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Olivia Aranha, MD, PhD

CONTACT

557-747-2105; oaranha@wustl.edu

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 17, 2026
• First Posted: June 23, 2026
• Study Start (Estimated): August 31, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2032
• Last Updated: June 23, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)