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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT06336148
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Actym Therapeutics, Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Recruiting
Countries Australia, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Solid Tumor
Additional Details

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.

Arms & Interventions

Arms

Experimental: ACTM-838 Monotherapy

Escalating doses of ACTM-838 in Part 1a followed by expansion in Part 1b at the recommended dose determined in Part 1a

Interventions

Drug: - ACTM-838

Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Los Angeles 5368361, California 5332921

Status

Recruiting

Address

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

Los Angeles 5368361, California 5332921, 90033

Pittsburgh 5206379, Pennsylvania 6254927

Status

Recruiting

Address

UPMC Hillman Cancer Center, 5115 Centre Ave

Pittsburgh 5206379, Pennsylvania 6254927, 15232

International Sites

Westmead 2143973, New South Wales 2155400, Australia

Status

Completed

Address

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

Westmead 2143973, New South Wales 2155400, 2145

Bedford Park 2076918, South Australia 2061327, Australia

Status

Completed

Address

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

Bedford Park 2076918, South Australia 2061327, 5042

Melbourne 2158177, Victoria 2145234, Australia

Status

Completed

Address

Alfred Hospital, 55 Commercial Road, Site No: 201

Melbourne 2158177, Victoria 2145234, 3004

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