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

Introduction

• Org Study ID: ACTM-838-01
• NTC ID: NCT06336148
• Lead Sponsor Name: Actym Therapeutics, Inc.
• Status: RECRUITING

Conditions

• Renal Cell Carcinoma

Brief 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.

Eligibility Criteria

Inclusion Criteria:

1. Advanced solid tumor for which there is no remaining standard curative therapy and no therapy with a demonstrated survival benefit, or they must be ineligible to receive or refuse to receive such therapy
2. At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST ) v1.1; amenable for biopsy, and radiographically apparent on computed tomography (CT) or magnetic resonance imaging (MRI )
3. Eastern Cooperative Oncology Group (ECOG) 0-1
4. Adequate hematologic, hepatic, pulmonary, and cardiac function
5. CD4 count >500/mL at screening
6. Additional protocol defined inclusion criteria may apply

Exclusion Criteria:

1. Active autoimmune disease requiring systemic treatment (i.e., with use of disease modifying agents, systemic corticosteroids or immunosuppressive drug) within the past 6 months prior to dosing of investigational product.
2. History of permanent artificial implants (e.g., prosthetic joints, artificial heart valves, pacemakers, orthopaedic screw[s], metal plate[s], bone graft[s], or other exogenous implant[s]
3. Known history of cholelithiasis or urolithiasis
4. History of valvular disease, arterial aneurisms or arterial or venous malformation
5. Known active brain metastases
6. Documented active Salmonella infection or vaccination with Salmonella typhi within 6 months prior to investigational product dosing
7. Additional protocol defined inclusion/exclusion criteria may apply