Clinical Trial: A Study to Evaluate Safety and Efficacy of AMB-05X Injections in Subjects With TGCT

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: A Phase 2, Open-Label, Adaptive, Dose-Ranging Study With Long-Term Extension to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Intra Articular AMB-05X Injections in Subjects With

Brief Summary: AMB-051-07 is an Open-Label, Adaptive, Dose-Ranging Study with Long-Term Extension which will enroll approximately 48 adult subjects with TGCT for IA doses over a 24-week dosing period (Part 1) with a Part 2 OLE of 6 treatment and/or observational cycles of 12 weeks each followed by 12 weeks of follow-up.

Detailed Summary:
Sponsor: AmMax Bio, Inc.

Current Primary Outcome: Proportion of subjects who achieve an OR (objective response rate [ORR]) by central radiology review per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Original Primary Outcome: Proportion of subjects who achieve an OR (objective response rate [ORR]) by central radiology review per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)

Current Secondary Outcome:

Original Secondary Outcome:

Information By: AmMax Bio, Inc.

Dates:
Date Received: April 22, 2022
Date Started: January 26, 2023
Date Completion: January 26, 2023
Last Updated: July 05, 2023
Last Verified: February 01, 2023