Description:
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.
Title
- Brief Title: Dose Escalation and Expansion Study of FLX475 Monotherapy and 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
Clinical Trial IDs
- ORG STUDY ID:
FLX475-02
- SECONDARY ID:
KEYNOTE-877
- NCT ID:
NCT03674567
Conditions
Interventions
| Drug | Synonyms | Arms |
|---|
| FLX475 | | Part 1a: Monotherapy Dose Escalation |
| Pembrolizumab | Keytruda | Part 1b: Combination Dose Escalation |
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Part 1a: Monotherapy Dose Escalation | Experimental | Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 as monotherapy. | |
| Part 1b: Combination Dose Escalation | Experimental | Eligible subjects will be enrolled in sequential cohorts treated with successively higher doses of FLX475 in combination with pembrolizumab. | |
| Part 2a: Monotherapy Expansion Cohorts | Experimental | Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 as monotherapy; additional subjects in each cohort may be enrolled in Stage 2. | |
| Part 2b: Combination Expansion Cohorts | Experimental | Eligible subjects will be initially enrolled in Stage 1 of parallel expansion cohorts of FLX475 in combination with pembrolizumab; additional subjects in each cohort may be enrolled in Stage 2. | |
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Safety and tolerability of FLX475 as a single agent and in combination with pembrolizumab measured by the incidence of adverse events, including dose-limiting toxicities and maximum tolerated dose |
| Time Frame: | Approximately 18 weeks |
| Safety Issue: | |
| Description: | |
Details
| Phase: | Phase 1/Phase 2 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | RAPT Therapeutics, Inc. |
Trial Keywords
- Non-small Cell Lung Cancer
- Head and Neck Squamous Cell Carcinoma
- Breast Cancer
- Urothelial Carcinoma
- Nasopharyngeal Carcinoma
- Cervical Cancer
- Lymphoma
Last Updated
June 29, 2021
