Clinical trial · Interventional
Study of ACR-2316 in Specific Advanced Solid Tumors
ACR-2316-101: Phase 1/2 Study of ACR-2316 in Subjects With Advanced Solid Tumors
NCT06667141CI-TRIAL-00106254recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This is a first in-human, Open-label Phase 1/2 study to assess the safety and activity of ACR-2316 for the treatment of subjects with specific, histologically confirmed, locally advanced, recurrent or metastatic solid tumors.
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 |
|---|---|---|---|
| Specific Advanced Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACR-2316 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Dose escalation
- description
- ACR-2316 will be administered using a 3-week or a 4-week schedule.
- interventionNames
- Drug: ACR-2316
- type
- EXPERIMENTAL
- label
- Dose expansion
- description
- ACR-2316 will be administered using a 3-week schedule.
- interventionNames
- Drug: ACR-2316
Primary outcomes (4)
- measure
- Dose Escalation
- timeFrame
- Number of DLT events during the DLT observation period (up to 28 days)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent. 2. Histologically or cytologically proven metastatic, recurrent or locally advanced selected solid tumors. 3. Must be willing to provide redacted pathology report and next-generation sequencing (NGS) reports. 4. Subjects should have received no more than 3 lines of systemic therapy for recurrent disease. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 at trial entry and an estimated life expectancy of at least 3 months. 6. Disease must be measurable with at least 1 unidimensional measurable lesion by RECIST v1.1. 7. Adequate organ functions. 8. Must have progressed after prior line of treatment. Exclusion Criteria (all participants): 1. Participants with known symptomatic brain metastases. 2. Participant had systemic therapy within 3 weeks prior to the first dose of study drug. 3. Participant had radiation therapy for curative intent within 4 weeks prior to the first dose of study drug. 4. Participant had palliative radiation therapy within 2 weeks prior to the first dose of study drug. 5. Women who are pregnant or lactating.
References
Publications (0)
Data not yet available
No reference posted for this study.