Clinical trial · Interventional
Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
A Multicenter, Open-Label Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of ICP-723 in Patients With Advanced Solid Tumors
NCT05537987CI-TRIAL-00063342unknownPhase 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)
During this study, dose escalation will be conducted in subjects with advanced solid tumors who have experienced treatment failure after clinical standard of care treatments or who currently have no effective treatment available to evaluate the safety, tolerability, and PK of ICP-723
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICP-723 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-723
- interventionNames
- Drug: ICP-723
Primary outcomes (1)
- measure
- Incidence and severity of dose-limiting toxicity (DLT), adverse events (AEs), and serious adverse events (SAEs). Frequency of dose interruptions, reductions and intensity
- timeFrame
- through study completion, an average of 1.5 years.
Secondary outcomes (8)
- measure
- Objective response rate (ORR) determined using RECIST 1.1 criteria.
- timeFrame
- Through study completion, an average of 4 years
- measure
- Disease control rate (DCR) determined using RECIST 1.1 criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with histopathologically confirmed locally advanced malignant solid tumors that are unresectable or metastatic and that are unresponsive to standard treatments or have relapsed; patients who have progressed under standard treatment including prior treatment with TRK or ROS1 inhibitors. 2. Male or female patients with age ≥18 years old and ≤80 years old. 3. Measurable lesion according to RECIST 1.1. 4. Adequate organ functions that meet protocol requirement criteria. 5. Patients with asymptomatic, stable primary central nervous system (CNS) tumors or CNS metastases (treated or untreated) 6. Participates voluntarily, signs informed consent, and follows the study treatment plan and scheduled visits. Exclusion Criteria: 1. Other than the advanced malignant solid tumor under study, patients with another one or more active malignancies within the previous 5 years except for locally curable cancers that have been apparently cured 2. Received systemic anti-cancer therapy including chemotherapy (except for oral fluorouracil chemotherapy), radiation therapy, hormones, targeted drugs, or biological immunotherapy within 4 weeks or 5 half-lives 3. Major surgery (thoracotomy, laparotomy, etc.) within 4 weeks or minor surgery (superficial skin surgery, lymphadenectomy, hernia repair, etc.) within 2 weeks before the first dose of the study drug 4. Clinically significant gastrointestinal/neurological dysfunction that may affect drug intake, transport, or absorption. 5. Has evidence of uncontrolled heart disease 6. At the investigator's discretion, evidence of severe or uncontrolled systemic disease. 7. Other conditions considered by the investigator to be inappropriate for participation in this study.
References
Publications (0)
Data not yet available
No reference posted for this study.