Clinical trial · Interventional
Study of ICP-105 in Solid Tumors Patients
A Phase I, Open-Label Study to Assess the Safety, Tolerability, Pharmacokinetics of ICP-105 in Patients With Advanced Solid Malignancies
NCT03642834CI-TRIAL-00059505completedPhase 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)
Open-label, non-randomized, Phase I, dose-escalating, first-in-man study.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICP-105 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-105 Single Arm
- description
- ICP-105 of multiple dose levels, dose escalation steps may be modified based on the safety from the previous dose.
- interventionNames
- Drug: ICP-105
Primary outcomes (1)
- measure
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
- timeFrame
- Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
- description
- will be evaluated by CTCAE v4.03
Secondary outcomes (3)
- measure
- Cmax
- timeFrame
- Every cycle (28 days) for approximately 24 months or earlier if patient terminates from the study
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 Years and older. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1. * At least one evaluable disease according to RECIST1.1. * Histologically or cytologically confirmed solid tumors, failure to respond to standard therapy, or for whom standard therapy does not exist. * Adequate bone marrow, liver, renal, and cardiovascular function. Exclusion Criteria: * Previous treatment with FGF19, FGFR4 inhibitors and/or pan-FGFR inhibitors. * Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal, targeted therapy, or investigational agents within four weeks of the first dose of ICP-105. * Major surgery within 6 weeks of the first dose of ICP-105. * Significant GI disorder(s) that could interfere with the absorption, metabolism, or excretion of ICP-105. * Crohn's disease with symptoms and systemic treatment. * Central nervous system (CNS) metastasis. * Current clinically significant cardiovascular disease including: * Any class 3 or 4 cardiac disease such as arrhythmia, congestive heart failure or myocardial infarction defined by the New York Heart Association Functional Classification, or left ventricular ejection fraction (LVEF) \< 50%, Primary cardiomyopathy, clinical significant QTc prolong history or QTc\>470ms (female) QTc\>450ms (male). * Known active bleeding within 2 months of screening or 6 months of bleeding history. * Lung function impairment by pleural effusion or ascites, any history of interstitial pneumonia, deep vein thrombosis, pulmonary embolism. * Known active infection with HBV, HCV or HIV or any uncontrolled active systemic infection. * Non-hematological toxicity must recover to ≤ Grade 1 from prior anti-cancer therapy (excluding alopecia, nausea and vomiting). * Lactating or pregnant women, or women who will not use contraception during the study and for 180 days after the last dose of study drug if sexually active and able to bear children.
References
Publications (0)
Data not yet available
No reference posted for this study.