FLX475 in Combination With Ipilimumab in Advanced Melanoma

• Sponsor: RAPT Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04894994
• Collaborator: (none)
• Enrollment: 20
• Locations: 4
• Arm: 1
• Anticipated Duration (Months): 26.9
• Patients Per Site: 5
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This clinical trial is a Phase 2, open-label study to determine the anti-tumor activity of FLX475 in combination with ipilimumab in subjects with advanced melanoma previously treated with an anti-PD-1 or anti-PD-L1 agent.

The study will be conducted starting with a safety run-in portion in which 6 eligible subjects will be enrolled and treated for at least one 3-week cycle to determine if the safety profile of FLX475+ipilimumab is acceptable to complete enrollment of the approximately 20-subject study.

Condition or Disease	Intervention/Treatment	Phase
Advanced Melanoma	Drug: FLX475; Drug: Ipilimumab	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase 2 Study of FLX475 in Combination With Ipilimumab in Advanced Melanoma
• Actual Study Start Date: Sep 3, 2021
• Anticipated Primary Completion Date: Jun 1, 2023
• Anticipated Study Completion Date: Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: FLX475 and ipilimumab combination therapy	Drug: FLX475; Tablet; Drug: Ipilimumab; IV infusion

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability of FLX475 in combination with ipilimumab measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0, including dose-limiting toxicities and serious adverse events. [Approximately 3 weeks]

2. Overall response rate in subjects treated with FLX475 in combination with ipilimumab [Through study completion (approximately 2 years)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Stage IV or unresectable Stage III advanced melanoma

• Prior treatment with at least 2 months of anti-PD-(L)1 agent

• Measurable disease at baseline

• 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 immunotherapy

• Prior treatment with ipilimumab or other CTLA-4 antagonists

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, Los Angeles	Los Angeles	California	United States	90095
2	Moffitt Cancer Center	Tampa	Florida	United States	33612
3	Washington University School of Medicine St. Louis	Saint Louis	Missouri	United States	63110
4	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• RAPT Therapeutics, Inc.

Investigators

• Study Chair: William Ho, MD, PhD, RAPT Therapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: RAPT Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04894994
• Other Study ID Numbers: FLX475-03
• First Posted: May 20, 2021
• Last Update Posted: Jun 14, 2022
• Last Verified: Jun 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by RAPT Therapeutics, Inc.: Neoplasms; Ipilimumab; Antineoplastic Agents; Immunological
• Additional relevant MeSH terms: Melanoma; Ipilimumab

Study Results

No Results Posted as of Jun 14, 2022