Solid Tumor
Conditions
Keywords
non-small cell lung cancer, head and neck cancer, esophageal cancer, ovarian cancer, cervical cancer, stomach cancer, thyroid cancer, renal cell cancer, mesothelioma, breast cancer, pancreatic cancer, colorectal cancer, sarcoma, immunotherapy, melanoma, bladder cancer, cholangiocarcinoma, bile duct cancer
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. The details on the Phase 1b dose expansion part will be incorporated in a future protocol amendment.
Interventions
DRUGACTM-838
Escalating doses of ACTM-838 in Part 1a and recommended dose in Part 1b
Sponsors
Actym Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Intervention model description
This is an Open label Single dose study.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events and serious adverse events - Part 1a | 1 year |
| Proportion of participants experiencing dose limiting toxicities - Part 1a | 28 Days |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Benefit Rate (CR, PR, or stable disease (SD) as best overall response) - Part 1a | 1 year |
| Duration of Response (DoR), defined as the time from date of first response (CR or PR) - Part 1a | 1 year |
| Progression free survival (PFS) - Part 1a | 1 year |
| Objective response rate (ORR) defined as complete response (CR) or partial response (PR) - Part 1a | 1 year |
| Amount of ACTM-838 in blood, urine, and faeces as measured by digital droplet-polymerase chain reaction (ddPCR) - Part 1a | 1 year |
| Tumor PD colonization as measured by ddPCR and payload delivery as measured by RNA detection - Part 1a | 1 year |
| Incidence of antidrug antibodies (ADA) to ACTM-838 - Part 1a | 1 year |
| Change in tumor markers - Part 1a | 1 year |
| Confirmed ORR defined as confirmed CR or confirmed PR - Part 1a | 1 year |
Countries
Australia, United States
Outcome results
None listed