Clinical trial · Interventional
A Phase 1a/1b Study of 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
NCT06336148CI-TRIAL-00096575terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Sponsor's strategic business decision
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACTM-838 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ACTM-838 Monotherapy
- description
- Escalating doses of ACTM-838 in Part 1a followed by expansion in Part 1b at the recommended dose determined in Part 1a
- interventionNames
- Drug: ACTM-838
Primary outcomes (2)
- measure
- Incidence and severity of adverse events and serious adverse events - Part 1a
- timeFrame
- 1 year
- measure
- Proportion of participants experiencing dose limiting toxicities - Part 1a
- timeFrame
- 28 Days
Secondary outcomes (9)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.