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Closed (no longer recruiting)Last updated: 2 February 2024

This phase I/II trial is evaluating the safety and activity of a new oral treatment (FLX475) alone and in combination with immunotherapy (Pembrolizumab) in patients with advanced cancerPhase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer

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 patients 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.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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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

Eligibility

Inclusion

  • Documented advanced or metastatic cancer ineligible for standard therapies with one of the following histologies

    • Dose Escalation: non-small cell lung cancer, head and neck squamous cell carcinoma, nasopharyngeal carcinoma, metastatic triple negative breast cancer, urothelial carcinoma, gastric cancer, esophageal carcinoma, cervical cancer, classical Hodgkin lymphoma
    • Dose Expansion: nasopharyngeal carcinoma, lymphoma, head and neck squamous cell carcinoma, cervical cancer, non-small cell lung cancer, triple-negative breast cancer
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
  • Evaluable disease at baseline (at least one measurable target lesion by imaging for expansion cohorts)
  • Tumor available for biopsy

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.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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