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Colorectal CancerPhase 2NCT07662031

Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer

A Phase 2 study testing Tovecimig, Irinotecan and Leucovorin in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Tovecimig, Irinotecan and Leucovorin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
31 Dec 2026to 31 Dec 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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. Prior adjuvant therapy does not count as a prior line.
  • At least 18 years of age.
  • ECOG performance status ≤ 2
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  • Adequate bone marrow and organ function as defined below:
  • Absolute neutrophil count ≥ 1.5 K/cumm
  • Platelets ≥ 100 K/cumm; transfusion during screening is allowed.
  • Hemoglobin ≥ 8.0 g/dL; transfusion during screening is allowed.
  • 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
  • International normalized ratio (INR) <1.5 x IULN and a partial thromboplastin time (PTT or aPTT) <1.5 x IULN if not receiving anticoagulation therapy.
  • Urine protein ≤ 1+. If urinalysis shows a protein result of > 1+, the total protein volume (<1.0 g/24hr) can be confirmed with a 24-hour urine test.
  • BNP <100 pg/mL
  • 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.

Who cannot join

  • 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.
  • Presence of clinically significant toxicities from prior anticancer therapy that have not resolved to Grade ≤ 1 (per CTCAE v6.0).
  • Surgery or major procedure, or systemic anticancer therapy within 4 weeks prior to C1D1. Procedures with the following characteristics will generally be considered as major surgery:
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  • Laparoscopic or open approach
  • Require inpatient admission,
  • Require overnight observation
  • Require general anesthesia
  • 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 elevate the patient's risk of hemorrhage, such as a bleeding diatheses, history of prior bowel perforation, clinically significant active bleeding (i.e. hemoptysis larger than a tablespoon within 3 weeks prior to C1D1, or history of arterial thrombotic/thromboembolic event(s).
  • Any non-healing wound, ulcer, or bone fracture.
  • Radiologic evidence of tumor invading or encasing a major blood vessel.
  • History of esophageal varices or bleeding peptic ulcer or erosive esophagitis or gastritis within 3 months.
  • High risk of gastrointestinal perforation or fistula formation (i.e. ulcerative colitis, Crohn's disease, inflammatory bowel disease, abdominal irradiation, etc.)
  • 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.
  • Current or recent use of anticoagulants or thrombolytic agents for therapeutic (as opposed to prophylaxis) purposes within 10 days of C1D1.
  • Prophylactic use of low molecular weight heparin (i.e. enoxaparin 40 mg/day) and non-low-molecular-weight heparin (non-LMWH) anti-coagulants, such as Eliquis (apixaban 5 mg/day) is allowed if patient has INR <2 or aPTT < 2 x IULN within 14 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.
  • Mean QT interval (Fridericia's formula) (QTcF) interval > 450 msec for male patients and > 470 msec for female patients on triplicate ECGs performed in screening.
  • A history of CHF (NYHA class II or higher) with 5 years prior to C1D1, LVEF < 50% on screening TTE/MUGA, uncontrolled hypertension (defined as SBP/DBP greater than 140/90 despite best supportive care at any time during screening), pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina, or any significant valvular disease.
  • Pregnant and/or breastfeeding. Women of childbearing potential must have a negative serum or urine pregnancy test within 14 days of C1D1.
  • HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection.
  • Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection.
  • History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Olivia Aranha, MD, PhD contact

557-747-2105

oaranha@wustl.edu

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Olivia Aranha, MD, PhD, 557-747-2105, oaranha@wustl.edu

    Olivia Aranha, MD, PhD

Other trials in United States

About this study

Official title: A Phase 2 Clinical Trial of Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer

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).

Being tested
Tovecimig, Irinotecan, Leucovorin, 5-Fluorouracil (5-FU)
Keywords
Tovecimig, Colorectal cancer, Microsatellite stable
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TovecimigBiological

    Also called CTX-009

    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.

  • IrinotecanDrug

    Also called Camptosar

    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.

  • LeucovorinDrug

    Also called Vykoura

    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.

  • 5-Fluorouracil (5-FU)Drug

    Also called Adrucil, 5-FU

    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.

Study groups in NCT07662031
Study groupRoleWhat they receive
Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)ExperimentalTreatment will be administered in 28-day cycles. On Day 1 and 15 of each cycle, patients will receive Tovecimig followed by the FOLFIRI regimen.
Receives: Biological: Tovecimig; Drug: Irinotecan; Drug: Leucovorin; Drug: 5-Fluorouracil (5-FU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (5)

  1. Progression-Free Survival (PFS)

    PFS is defined as the time from date of start of treatment to the date of disease progression or death, whichever occurs first. Alive patients without disease progression are censored at the last follow-up otherwise. PFS will be assessed using the Kaplan-Meier method.

    Progressive disease (PD) is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).

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

  2. Overall Survival (OS)

    OS is defined as the time from date of treatment start to the date of death. Alive patients are censored at the last follow-up otherwise. OS will be assessed using the Kaplan-Meier method.

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

  3. Number and types of adverse events (AEs)

    As assessed by CTCAE v6.0.

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

  4. Disease Control Rate (DCR)

    DCR is defined as complete response (CR) plus partial response (PR) plus stable disease (SD) as assessed per RECIST v1.1 as best overall response.

    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.

    SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

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

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

    ECOG performance scale is graded as follows:

    Grade 0: Normal activity. Fully active, able to carry on all pre-disease performance without restriction.

    Grade 1: Symptoms, but ambulatory. Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature (e.g., light housework, office work).

    Grade 2: In bed <50% of the time. Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours.

    Grade 3: In bed >50% of the time. Capable of only limited self-care, confined to bed or chair more than 50% of waking hours.

    Grade 4:100% bedridden. Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair.

    Grade 5: Death

    A lower ECOG performance score indicates a better quality of life.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2026
  2. Study start31 Dec 2026 (estimated)
  3. Primary completion31 Dec 2030 (estimated)
  4. Study completion31 Dec 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07662031
Sponsor's protocol ID
202608231
Status last verified
Nov 2026
First submitted
17 Jun 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tovecimig, Irinotecan and Leucovorin in people with Colorectal Cancer and Metastatic Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Olivia Aranha, MD, PhD (557-747-2105, oaranha@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall Response Rate (ORR) (time frame: Start of treatment to completion of treatment (estimated time up to 12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07662031.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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