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

Last updated: March 17, 2025
Sponsor: Actym Therapeutics, Inc.
Overall Status: Active - Recruiting

Phase

1

Condition

Neoplasms

Neuroblastoma

Treatment

ACTM-838

Clinical Study ID

NCT06336148
ACTM-838-01
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  1. Advanced solid tumor for which there is no remaining standard curative therapy andno therapy with a demonstrated survival benefit, or they must be ineligible toreceive 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 computedtomography (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

Exclusion Criteria:

  1. Active autoimmune disease requiring systemic treatment (i.e., with use of diseasemodifying agents, systemic corticosteroids or immunosuppressive drug) within thepast 6 months prior to dosing of investigational product.

  2. History of permanent artificial implants (e.g., prosthetic joints, artificial heartvalves, pacemakers, orthopaedic screw[s], metal plate[s], bone graft[s], or otherexogenous 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 6months prior to investigational product dosing

  7. Additional protocol defined inclusion/exclusion criteria may apply

Study Design

Total Participants: 35
Treatment Group(s): 1
Primary Treatment: ACTM-838
Phase: 1
Study Start date:
June 05, 2024
Estimated Completion Date:
July 31, 2026

Study 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.

Connect with a study center

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

    Westmead, New South Wales 2145
    Australia

    Completed

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

    Bedford Park, South Australia 5042
    Australia

    Completed

  • Alfred Hospital, 55 Commercial Road, Site No: 201

    Melbourne, Victoria 3004
    Australia

    Completed

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

    Los Angeles, California 90033
    United States

    Active - Recruiting

  • UPMC Hillman Cancer Center, 5115 Centre Ave

    Pittsburgh, Pennsylvania 15232
    United States

    Active - Recruiting

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