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New treatment option 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?
PF-08634404 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for carcinoma, renal cell.
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 a new medicine called PF-08634404 and how it works in adults with advanced Renal Cell Carcinoma (RCC)- a type of kidney cancer that is either locally advanced (spread to nearby tissues) or metastatic (spread to other parts of the body). The study will look at the safety of the study medicine, when given alone or with other anticancer medicines, and how this type of cancer responds to them.
- 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
- Participants may be excluded if they meet any of the following:
- 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
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
- Participants may be excluded if they meet any of the following:
- 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's taking place
- 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
- Denver, Colorado, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Ringgold, Georgia, United States
- Zion, Illinois, United States
- Boston, Massachusetts, United States
- Newton, Massachusetts, United States
+ 70 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 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 84 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.