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NCT06336148 | RECRUITING | Solid Tumor

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

Actym Therapeutics, Inc.

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.

Condition or disease

Solid Tumor

Intervention/treatment

ACTM-838

Phase

PHASE1

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 35 participants
Masking : NONE
Masking Description : Open label
Primary Purpose : TREATMENT
Official Title : A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors
Actual Study Start Date : 2024-06-05
Estimated Primary Completion Date : 2026-01
Estimated Study Completion Date : 2026-07

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors

Location Details

NCT06336148

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave.

Los Angeles, California, United States, 90033

RECRUITING

United States, Pennsylvania

UPMC Hillman Cancer Center, 5115 Centre Ave

Pittsburgh, Pennsylvania, United States, 15232

COMPLETED

Australia, New South Wales

Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200

Westmead, New South Wales, Australia, 2145

COMPLETED

Australia, South Australia

Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202

Bedford Park, South Australia, Australia, 5042

COMPLETED

Australia, Victoria

Alfred Hospital, 55 Commercial Road, Site No: 201

Melbourne, Victoria, Australia, 3004