Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is a non-randomised, dose escalation and expansion study in which patients will receive either FLX475 as a monotherapy or in combination with Pembrolizumab at escalating or defined doses. In Part 1 of the study, subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy or in combination with pembrolizumab. In Part 2 of the study, subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy or in combination with pembrolizumab.
Conditions
This trial is treating people with non-small cell lung cancer, head and neck squamous cell carcinoma,cancer of the nose, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, oesophageal cancer, cervical cancer or Hodgkin lymphoma
Eligibility
Exclusion
- History of allergy or severe hypersensitivity to biologic agents
- History of Grade 3-4 immune-related adverse events leading to discontinuation of prior immuno-oncology treatment
- Active autoimmune disease or serious autoimmune disease within past 2 years requiring systemic therapy
- History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, (non-infectious) pneumonitis that required steroids, or symptoms of active pneumonitis
- Prior allogeneic hematopoietic stem cell transplant within 5 years, or prior allogeneic organ transplant
- Active graft-versus-host disease
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
Exclusion
- You have certain types of non-cancer medical conditions.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
RAPT Therapeutics, Inc.
Scientific Title
Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer
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