Spots Global Cancer Trial Database for A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Phase 1a/1b Study of ACTM-838 in Patients With Advanced Solid Tumors
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
Study ID: NCT06336148
Conditions
Interventions
Study Description
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.
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200, Westmead, New South Wales, Australia
Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202, Bedford Park, South Australia, Australia
Alfred Hospital, 55 Commercial Road, Site No: 201, Melbourne, Victoria, Australia
Contact Details
Name: SVP, Clinical Development, MD, PhD
Affiliation: Actym Therapeutics, Inc.
Role: STUDY_DIRECTOR
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