Testing ACTM-838 in patients with advanced solid tumors
A Phase 1a/1b Open-label, Dose-Escalation and Expansion Study of ACTM-838 as a Single Agent in Patients With Advanced Solid Tumors
PHASE1 · Actym Therapeutics, Inc. · NCT06336148
This study is testing a new drug called ACTM-838 to see if it is safe and effective for people with advanced solid tumors that haven't responded to other treatments.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 35 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Actym Therapeutics, Inc. (industry) |
| Locations | 5 sites (Los Angeles, California and 4 other locations) |
| Trial ID | NCT06336148 on ClinicalTrials.gov |
What this trial studies
This is a first-in-human study divided into two parts that evaluates the safety, tolerability, and activity of ACTM-838 in patients with advanced solid tumors that are resistant to standard treatments. Part 1a focuses on dose escalation to determine the maximum tolerated dose and optimal biological dose of ACTM-838 as a monotherapy. Part 1b will expand on this by further evaluating the drug in specific tumor types based on emerging data from Part 1a and pre-clinical studies.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced solid tumors who have exhausted standard treatment options or are ineligible for them.
Not a fit: Patients with active autoimmune diseases requiring systemic treatment or those with certain medical implants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have no effective therapies.
How similar studies have performed: Other studies have shown promise with similar approaches in targeting advanced solid tumors, but this specific drug and methodology are novel.
Eligibility criteria
Show full 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
Where this trial is running
Los Angeles, California and 4 other locations
- University of Southern California Norris Comprehensive Cancer Center, 1441 Eastlake Ave. — Los Angeles, California, United States (RECRUITING)
- UPMC Hillman Cancer Center, 5115 Centre Ave — Pittsburgh, Pennsylvania, United States (RECRUITING)
- Westmead Hospital, Cnr Hawkesbury Road and Darcy Road, Site No: 200 — Westmead, New South Wales, Australia (COMPLETED)
- Southern Oncology Clinical Research Unit, Level 3, Mark Oliphant Building, 5 Laffer Drive, Site No: 202 — Bedford Park, South Australia, Australia (COMPLETED)
- Alfred Hospital, 55 Commercial Road, Site No: 201 — Melbourne, Victoria, Australia (COMPLETED)
Study contacts
- Study coordinator: Andra Schemera, BA
- Email: aschemera@actymthera.com
- Phone: 4153091791
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Solid Tumor, non-small cell lung cancer, head and neck cancer, esophageal cancer, ovarian cancer, cervical cancer, stomach cancer, thyroid cancer