Clinical trial 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?
This is an investigational medicine being studied to see if it helps treat colorectal cancer that has spread.
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
- This study is testing whether a new medicine works better than a standard drug. It checks if adding the new drug to chemo helps people with advanced cancer.
- Who it's for
- You may be able to join if you are an adult with colon or rectal cancer that has spread.
- What's involved
- You would get medicine through a vein at a clinic. You might get the new drug or a standard drug, but you will not know which one.
- Time commitment
- The study lasts about 33 months with regular visits for treatment and health checks.
- 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
- 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
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation
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
- 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 is enrolling
- 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
- Encinitas, California, United States
- Fremont, California, United States
- La Jolla, California, United States
- Palo Alto, California, United States
- Roseville, California, United States
- Sacramento, California, United States
- San Diego, California, United States
- San Francisco, California, United States
- San Mateo, California, United States
+ 248 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, but 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?
This study is enrolling now at 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 262 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.