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.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b
University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave.
Los Angeles, California, United States
UPMC Hillman Cancer Center, 5115 Centre Ave
Pittsburgh, Pennsylvania, United States
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
Incidence and severity of adverse events and serious adverse events - Part 1a
Time frame: 1 year
Proportion of participants experiencing dose limiting toxicities - Part 1a
Time frame: 28 Days
Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a
Time frame: 1 year
Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a
Time frame: 1 year
Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a
Time frame: 1 year
Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a
Time frame: 1 year
Progression free survival (PFS) - Part 1a
Time frame: 1 year
Change in tumor markers - Part 1a
Time frame: 1 year
Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a
Time frame: 1 year
Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a
Time frame: 1 year
Incidence of antidrug antibodies (ADA) to ACTM-838 - Part 1a
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Bedford Park, South Australia, Australia
Alfred Hospital, 55 Commercial Road, Site No: 201
Melbourne, Victoria, Australia
Time frame: 1 year