Clinical trial for Carcinoma, Renal Cell
Official title Symbiotic-GU-08: A Study to Learn About the Medicine Called PF-08634404 Dosed Alone and in Combination With Other Anticancer Therapies in Adults With Locally Advanced or Metastatic Renal Cell Cancer
ClinicalTrials.gov ID: NCT07227415
What this study is testing
What is PF-08634404?
This is an investigational medicine being studied as a potential treatment for advanced kidney cancer.
Also referred to as SSGJ-707.
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 called PF-08634404 is safe. It also looks at how well it works alone or with other cancer drugs.
- Who it's for
- You may be able to join if you are an adult with advanced kidney cancer that has not been treated yet.
- What's involved
- You would get the study medicine through a vein. You might also receive other anticancer medicines at the same time.
- Time commitment
- The study involves visits to a clinic for treatment and check-ups.
- Phase 2: a mid-size study of how well it works
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
- 18 years of age or older at screening
- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
- At least one measurable (as defined by the investigator) and untreated lesion
- Adequate hematologic, hepatic, cardiac and renal function
- No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \>12 months prior)
You likely can't join if
- Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
- Clinically significant risk of haemorrhage or fistula
- History of another malignancy within 3 years
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- active autoimmune diseases requiring systemic treatment within the past 2 years
- uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
See the full eligibility criteria
- 18 years of age or older at screening
- Locally advanced (not amenable to curative surgery or radiation therapy) or metastatic RCC with diagnosis confirmed by histology/cytology
- At least one measurable (as defined by the investigator) and untreated lesion
- Adequate hematologic, hepatic, cardiac and renal function
- No prior systemic therapy for RCC (immunotherapy after surgery is allowed if received \>12 months prior)
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- All International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) based risk categories
- Known active brain lesions including leptomeningeal metastasis, brainstem, meningeal or spinal cord metastases or compression.
- Clinically significant risk of haemorrhage or fistula
- History of another malignancy within 3 years
- History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
- active autoimmune diseases requiring systemic treatment within the past 2 years
- uncontrolled cardiac and other comorbidities within 6 months prior to the first dose
- Major surgery or severe trauma within 4 weeks before the first dose, or planned major surgery during the study
- History of severe bleeding tendency or coagulation dysfunction
- History of oesophageal varices, severe ulcers, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess or acute gastrointestinal bleeding within 6 months prior to the first...
- Acute, chronic or symptomatic infections
- Participants with history of immunodeficiency
The study team makes the final eligibility decision.
Where it is enrolling
- Phoenix, Arizona, United States
- Scottsdale, Arizona, United States
- Fayetteville, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Duarte, California, United States
- Encinitas, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Long Beach, California, United States
- San Diego, California, United States
- Upland, California, United States
- Vista, California, United States
- Aurora, Colorado, United States
- Denver, Colorado, United States
- Highlands Ranch, Colorado, United States
- Lakewood, Colorado, United States
- Lone Tree, Colorado, United States
- Jacksonville, Florida, United States
- Lake Mary, Florida, United States
+ 85 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 Phoenix, Arizona, United States; Scottsdale, Arizona, United States; Fayetteville, Arkansas, United States; Rogers, Arkansas, United States; Springdale, Arkansas, United States; Duarte, California, United States and 99 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.