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New treatment option for Intestinal Neoplasms
Official title 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
ClinicalTrials.gov ID: NCT07222800
What this study is testing
What is PF-08634404?
PF-08634404 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for intestinal neoplasms.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chandler, Arizona, United States
- Gilbert, Arizona, United States
- Glendale, Arizona, United States
- Goodyear, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Fayetteville, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Berkeley, California, United States
- Fremont, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
- Santa Rosa, California, United States
- Sunnyvale, California, United States
- Aurora, Colorado, United States
- Boulder, Colorado, United States
+ 221 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chandler, Arizona, United States; Gilbert, Arizona, United States; Glendale, Arizona, United States; Goodyear, Arizona, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States and 235 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.