Clinical trial · Interventional
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61in Subjects With Advanced Solid Tumors
An Open-Label, Multicenter, Single-Arm Phase 1 Clinical Trial to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASC61 in Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1, open-label, multicenter, single-arm, dose escalation study, designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of single-agent ASC61(an orally bioavailable small-molecule inhibitor of PD-L1) in subjects with advanced solid tumors for whom no standard therapy is available.
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ASC61 200 mg 1 | Drug | — | UNRESOLVED |
| ASC61 200 mg 2 | Drug | — | UNRESOLVED |
| ASC61 300 mg | Drug | — | UNRESOLVED |
| ASC61 400 mg | Drug | — | UNRESOLVED |
| ASC61 600 mg | Drug | — | UNRESOLVED |
| ASC61 800 mg | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- ASC61 200 mg 1
- description
- ASC61 200 mg orally once
- interventionNames
- Drug: ASC61 200 mg 1
- type
- EXPERIMENTAL
- label
- ASC61 200 mg 2
- description
- ASC61 200 mg orally twice daily
- interventionNames
- Drug: ASC61 200 mg 2
- type
- EXPERIMENTAL
- label
- ASC61 300 mg
- description
- ASC61 300 mg orally twice daily
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adults ≥ 18 years of age at the time of screening * Histological or cytological diagnosis of advanced/metastatic solid tumor that is resistant to standard therapy or for which no standard therapy is available, regardless of cancer stage and previous experienced therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * At least one measurable lesion, as defined by RECIST 1.1 Exclusion Criteria: * Known symptomatic brain metastases requiring steroids * Known history of another primary solid tumor * Subjects discontinued prior therapy with immune checkpoints due to toxicity if previously received therapy with this class of drugs * Known history of idiopathic pulmonary fibrosis, drug-induced pneumonitis, or evidence of active pneumonia or pneumonitis * Gastrointestinal disorders that might affect drug absorption
References
Publications (0)
Data not yet available