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NCT Number: NCT07222800

Symbiotic-GI-03: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Metastatic Colorectal Cancer

The purpose of this study is to learn more about a new medicine called PF-08634404, and how well it works in people with cancer of the colon or rectum (CRC)). The goal is to understand if the new study medicine, combined with chemotherapy that is approved for colorectal cancer, can help people whose cancer has spread or returned after treatments taken before.

To join the study, participants must meet the following conditions:

* Be 18 years or older. * Have colorectal cancer that has spread to other parts of your body. * Be in good enough health to receive study treatment. * Should not be pregnant before starting treatment.

Participants will be randomized (like flipping a coin) to one of 2 different treatment arms. The first arm (Arm A) will include the new medicine PF-08634404 in combination with chemotherapy that is approved for colorectal cancer, and the second arm (Arm B) will include an approved medicine for colorectal cancer, called Bevacizumab, in combination with chemotherapy that is approved for this type of cancer. Participants and their doctors will not know which arm they are being assigned to. Participants will receive all the study medications through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, and participants may continue receiving it if it is helping and they are not experiencing serious side effects.

The medicine will be given at a clinical site, where trained medical staff will check participants during and after each treatment.

* The study is expected to last approximately 33 months for each participant. * Participants will have regular visits to the study site for treatment, health checks, and tests. * After stopping treatment, participants will return for a final visit about 30 to37 days later to check their health and review any side effects. * Follow-up will continue every 12 weeks by phone or in person or by reviewing health records to check on health status and any new treatments.

Recruiting

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Key information

Conditions

Intestinal Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centro de Investigación Pergamino, Pergamino, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histological or cytological confirmed colorectal adenocarcinoma.
  • Evidence of Stage IV metastatic disease.
  • No prior systemic therapy for metastatic disease.
  • Eastern Cooperative Oncology Group performance status (ECOG) 0-1
  • At least one measurable lesion according to RECIST 1.1 per Investigator assessment.
  • Adequate hepatic, liver, and renal function

Exclusion criteria

Participants are excluded from the study if any of the following criteria apply:

  • Locally confirmed BRAF V600E mutation
  • Locally confirmed microsatellite instability (MSI)-high or DNA mismatch repair deficiency (dMMR) colorectal cancer
  • Participants with known active symptomatic CNS lesions, including leptomeningeal metastasis, brainstem, meningeal, or spinal cord metastases or compression
  • Clinically significant risk of hemorrhage or fistula
  • Major surgery or severe trauma within 4 weeks prior to the first dose, or planned major surgery during the study
  • History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
  • Any Grade ≥3 bleeding/hemorrhage events within 28 days of Cycle 1 Day 1, or prior history of clinically significant bleeding events
  • Clinically significant cardiovascular disease, or other comorbidities, within 6 months prior to first dose
  • Participants with active autoimmune diseases requiring systemic treatment within the past 2 years
  • Evidence of non-infectious or drug-induced interstitial lung disease (ILD) pneumonitis

Treatment and study plan

PF-08634404

Drug

Solution for infusion

Bevacizumab

Biological

Injection for intravenous use

Other names: Avastin

Chemotherapy

Drug

Injection for intravenous use

Primary outcomes

  1. Progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1) by Blinded Independent Central Review (BICR)

    Time frame: Approximately 4 years

    Progression-free survival is defined as the time from the date of randomization to the date of the first documentation of objective progressive disease (PD) assessed by BICR per RECIST 1.1, or death due to any cause, whichever occurs first.

  2. Overall survival (OS)

    Time frame: Approximately 4 years

    Overall survival defined as the time from the date of randomization to the date of death due to any cause.

Secondary outcomes

  1. PFS per RECIST 1.1 by investigator assessment

    Time frame: Approximately 4 years

    Progression Free Survival (PFS) is defined as the time from the date of randomization to the date of the first documentation of objective PD assessed by investigator per RECIST 1.1, or death due to any cause, whichever occurs first.

  2. Objective Response Rate (ORR) by BICR

    Time frame: Approximately 4 years

    The proportion of participants who have a confirmed CR or PR, as best overall response assessed by BICR as per RECIST 1.1.

  3. Objective Response Rate (ORR) by investigator

    Time frame: Approximately 4 years

    The proportion of participants who have a confirmed CR or PR, as best overall response assessed by investigator as per RECIST 1.1.

  4. Duration of Response (DOR) by BICR

    Time frame: Approximately 4 years

    The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by BICR assessment per RECIST 1.1, or death due to any cause, whichever occurs first.

  5. DOR by investigator

    Time frame: Approximately 4 years

    The time from the first documentation of objective response (CR or PR that is subsequently confirmed) to the date of the first documentation of PD as determined by Investigator per RECIST 1.1, or death due to any cause, whichever occurs first.

  6. PFS2 (PFS after next-line therapy) by investigator

    Time frame: Approximately 4 years

    PFS2 is defined as the time from the date of randomization to the date of second objective disease progression or death due to any cause, whichever occurs first. Second objective disease progression is PD after the start of subsequent anticancer therapy (excluding curative surgery) as assessed by the investigator.

  7. Number of Participants with Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: Through 90 days after the last study intervention; Approximately 4 years

  8. Number of Participants With Clinical Laboratory Abnormalities

    Time frame: Through 90 days after the last study intervention; Approximately 4 years

  9. Pharmacokinetics (PK): Serum concentration of PF-08634404

    Time frame: Approximately 21 months

  10. Immunogenicity: Incidence of positive Anti-Drug Antibody (ADA)

    Time frame: Approximately 21 months

    To characterize the immunogenicity of PF-08634404

  11. Mean scores and Change from baseline in the global health status/quality of life (QoL) score on the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)

    Time frame: Approximately 4 years

    The EORTC QLQ-C30 is a questionnaire for quantitative measure of health-related quality of life pertinent to participants with a broad range of cancers who are participating in international clinical trials.

  12. Mean score change from baseline in participant reported function and symptoms scales per EORTC QLQ-CR29

    Time frame: Approximately 4 years

    The EORTC QLQ-CR29 is a supplemental colorectal cancer-specific module with measures of symptoms associated with colorectal cancer.

  13. Time to definitive deterioration (TTdD) in the global health status/QoL score on the EORTC QLQ-C30

    Time frame: Approximately 4 years

    TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.

  14. Time to definitive deterioration (TTdD) in participant reported function and symptoms per EORTC QLQ-CR29

    Time frame: Approximately 4 years

    TTdD is defined as the time from date of randomization to first onset of Patient Reported Outcome (PRO) deterioration without subsequent recovery.

Study contacts

Contact information is provided by the study sponsor or research team.

Pfizer CT.gov Call Center

CONTACT

[email protected]

1-800-718-1021

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

AN INTERVENTIONAL, PHASE 3, DOUBLE-BLIND, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-08634404 IN COMBINATION WITH CHEMOTHERAPY VERSUS BEVACIZUMAB IN COMBINATION WITH CHEMOTHERAPY IN TREATMENT-NAÏVE PARTICIPANTS WITH METASTATIC COLORECTAL CANCER

Important dates

Study start
2025
Primary completion
2030
Study completion
2031
First posted
Oct 30, 2025
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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