Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study has two parts.
Part 1a will evaluate how safe and tolerable escalating doses of the drug ACTM-838 are to determine the maximum tolerated dose (MTD) and/or optimum biological dose (OBD) when given by itself. This part wil also determine the dose recommendation for the Part 1b.
Part 1b will further evaluate ACTM-838 in participants with advanced specific tumour types (defined pathogically, clinically and/or molecularly) using the data obtained from Part 1a as well as the pre-clinical program. Further details on the Phase 1b dose expansion is to be included in the future.
Conditions
This trial is treating people with solid tumors
Eligibility
Inclusion
- 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
- 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 )
- Eastern Cooperative Oncology Group (ECOG) 0-1
- Adequate hematologic, hepatic, pulmonary, and cardiac function
- CD4 count >500/mL at screening
- Additional protocol defined inclusion criteria may apply
Exclusion
- 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.
- 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]
- Known history of cholelithiasis or urolithiasis
- History of valvular disease, arterial aneurisms or arterial or venous malformation
- Known active brain metastases
- Documented active Salmonella infection or vaccination with Salmonella typhi within 6 months prior to investigational product dosing
- Additional protocol defined inclusion/exclusion criteria may apply
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Actym Therapeutics, Inc.
Scientific 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
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