Clinical trial · Interventional
A Study of ICP-033 in Patients With Advanced Solid Tumors
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-033 in Patients With Solid Tumors
NCT05367232CI-TRIAL-00073740unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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-033 Tablets 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-033 tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-033 Dose Escalation
- description
- Drug: ICP-033 tablet Administered orally，once a day，every 28 days is a cycle.
- interventionNames
- Drug: ICP-033 tablet
Primary outcomes (4)
- measure
- The incidence and severity of adverse event (AE) of ICP-033 assessed by NCI-CTCAE V5.0.
- timeFrame
- through study completion, an average of 2 years
- description
- To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
- measure
- Dose-Limiting Toxicities (DLTs)
- timeFrame
- through study completion, an average of 2 years
- description
- To assess the safety and tolerability of ICP-033 in patients with advanced solid tumors.
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. Pregnant and lactating women, or women planning to become pregnant during the study through at least 6 months after the last dose of study drug. 2. Patients with unstable primary central nervous system (CNS) tumors or CNS metastases. 3. Patients who have active or history of interstitial lung disease or noninfectious pneumonia. 4. Patients with QTc \> 450 ms in males and \> 470 ms in females on ECG at screening, or other clinically significant abnormalities in the ECG at the discretion of the investigator. 5. Patient with the Medication history and surgical history as stated in the protocol 6. Those who are unsuitable for blood collection or contraindicated for blood collection. 7. Other conditions considered unsuitable for participation in this trial at the discretion of the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.