NCT06336148

A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors

A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Actym Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a first in human (FIH) 2-part study using ACTM-838 in patients with advanced solid tumors resistant to standard of care treatment. Part 1a will evaluate dose escalation and Part 1b will evaluate dose expansion.

Detailed description

This study has 2 parts. Part 1a will evaluate the safety and tolerability and activity of escalating doses of ACTM-838 to estimate the maximum tolerated dose (MTD) and/or the optimum biological dose (OBD) for ACTM-838 as a monotherapy and determine the dose recommended for Part 1b. Part 1b will further evaluate ACTM-838 in patients with advanced specific tumor types (defined pathologically, clinically and/or molecularly) based on data emerging from the Phase 1a and the pre-clinical program. The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment.

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	ACTM-838	Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b

Timeline

• Start date: 2024-06-05
• Primary completion: 2025-08-28
• Completion: 2025-08-28
• First posted: 2024-03-28
• Last updated: 2025-10-15

Locations

5 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study