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

About

Brief Summary

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.

To join the study, participants must be adults; with locally advanced or metastatic RCC; who have not received treatment for their advanced kidney cancer.

Participants will receive study medicine either alone or with other anticancer medicines. The medicine will be given through intravenous (IV) infusions, which means it will be injected directly into a vein. All treatments will take place at clinical study sites, where trained medical staff will take care of participants during and after each visit.

Primary Purpose

Treatment

Study Type

Interventional

Phase

Phase 1/Phase 2

Eligibility

Gender

All

Healthy Volunteers

Minimum Age

18 Years

Maximum Age

N/A

Inclusion 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

Exclusion Criteria:

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 dose
Acute, chronic or symptomatic infections
Participants with history of immunodeficiency