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Tovecimig Plus FOLFIRI in Second Line Metastatic Colorectal Cancer

ConditionsColorectal CancerMetastatic Colorectal Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWashington University School of Medicine

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Surgery or major procedure, or systemic anticancer therapy within 4 weeks prior to C1D1.

Trial design

Design model

Single group

Treatments tested in this trial

  • Tovecimig

    Biological/Vaccine

    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.

  • 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.

  • 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.

  • 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.

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Tovecimig and Irinotecan + Leucovorin + 5-Fluorouracil (FOLFIRI regimen)Experimental treatment 4 interventions

Trial outcomes

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.

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

Secondary outcomes

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).

Time frame
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.

Time frame
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.

Time frame
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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Compass Therapeutics

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: