Clinical trial · Interventional
A Study of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients With Advanced Solid Tumors
A Phase Ia /Ib Dose Finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 and ICP-189 in Combination With Anti-PD-1 Monoclonal Antibody in Patients 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)
A Dose finding Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Preliminary Anti-Tumor Activity of ICP-189 Tablets and ICP-189 Tablets in Combination with Anti-PD-1 Monoclonal Antibody in Patients with Advanced 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 |
|---|---|---|---|
| Patients With Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICP-189 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Phase Ia: ICP-189 Dose Escalation
- interventionNames
- Drug: ICP-189
Primary outcomes (3)
- measure
- The incidence and severity of adverse event (AE) of ICP-189 assessed by NCI-CTCAE V5.0
- timeFrame
- through study completion, an average of 2 years
- description
- To assess the safety and tolerability of ICP-189 in patients with advanced solid tumors.
- measure
- Dose-Limiting Toxicities (DLTs)
- timeFrame
- through study completion, an average of 2 years
- description
- Percentage of Participants Experiencing Dose Limiting Toxicities (DLTs).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1; 2. Patients with histologically confirmed locally advanced unresectable or metastatic solid tumors; 3. At least one measurable lesion according to RECIST 1.1. Exclusion Criteria: 1. Patients who have had other cancer(s) within 5 years prior to the first dose, except for locally curable cancers that have been apparently cured; 2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases; 3. Patients who have an active autoimmune disease or have had an autoimmune disease with risk of recurrence; 4. Patients who have active or history of interstitial lung disease or non-infectious pneumonia; 5. Patients who have a history of severe allergic reaction to any component of ICP-189 tablets or anti-PD-1 antibody (\> grade 3 assessed by CTCAE 5.0). Other protocol-defined inclusion/exclusion criteria apply.
References
Publications (0)
Data not yet available