Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Bartosz Chmielowski (ucla)

Description

Summary

This clinical trial is a Phase 1/2, open-label, sequential-group, dose-escalation and cohort expansion study to determine the safety and preliminary anti-tumor activity of FLX475 as monotherapy and in combination with pembrolizumab.

The study will be conducted in 2 parts, a dose-escalation phase (Part 1) and a cohort expansion phase (Part 2). 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.

Official Title

Phase 1/2 Dose-Escalation and Expansion Study of FLX475 Alone and in Combination With Pembrolizumab in Advanced Cancer

Keywords

Advanced Cancer, Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Breast Cancer, Urothelial Carcinoma, Nasopharyngeal Carcinoma, Cervical Cancer, Lymphoma, Neoplasms, Pembrolizumab, FLX475, pembrolizumab (KEYTRUDA®)

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  • 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

Locations

  • University of California, Los Angeles JCCC Clinical Research Unit
    Los Angeles California 90024 United States
  • City of Hope
    Duarte California 91010 United States

Lead Scientist at University of California Health

  • Bartosz Chmielowski (ucla)
    HS Clinical Professor, Medicine. Authored (or co-authored) 127 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
RAPT Therapeutics, Inc.
ID
NCT03674567
Phase
Phase 1/2 research study
Study Type
Interventional
Participants
About 323 people participating
Last Updated