Clinical trial · Interventional
A Clinical Trial of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
A Phase II Clinical Trial to Evaluate the Efficacy and Safety of ICP-192 in Treated Patients With Advanced Solid Tumors With FGF/FGFR Gene Alterations
NCT05372120CI-TRIAL-00063011unknownPhase 2ClinicalTrials.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)
This is a phase II clinical trial in treated patients with advanced solid tumors with FGF/FGFR gene alterations. The purpose of this study is to evaluate the efficacy and safety of ICP-192.
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 Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICP-192 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ICP-192
- description
- 20 mg once daily
- interventionNames
- Drug: ICP-192
Primary outcomes (1)
- measure
- Objective response rate (ORR)
- timeFrame
- From the time of first dose until objective disease progression, an average of 6 months
- description
- ORR based on assessment of confirmed Complete response (CR) and partial response (PR) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST).
Secondary outcomes (2)
- measure
- Duration of response (DOR)
- timeFrame
- From the time of first dose until objective disease progression, an average of 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed the ICF and Age ≥ 18 years old, either sex. 2. ECOG ≤ 1. 3. Life expectancy of at least 3 months. 4. Part 1 (head and neck cancer cohort): Patients with HNC cancer who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration 5. Part 2 (other solid tumor cohorts): Patients with other solid tumor who have failed or cannot tolerate standard therapy, and with FGF/FGFR gene alteration 6. At least one measurable lesion as the target lesion at screening assessed according to RECIST V1.1 criteria. Exclusion Criteria: 1. Prior treatment with selective FGFR inhibitors or FGFR antibodies. 2. Any corneal or retinal abnormalities that may result in an increased risk of ocular toxicity. 3. Previously or currently endocrine alterations affecting the regulation of calcium-phosphorus homeostasis. History and/or current evidence of extensive tissue calcification.
References
Publications (1)
- DERIVEDXue L, Zhu G, Wang P, Yang K, Sun Y, Li W, Li Z, Jiang C, Cai Q, Fang M, Hu M, Ge M, Zhou W, Li S, Guo Y. FGF/FGFR Alteration Type as a Candidate Enrichment Biomarker for Gunagratinib in Recurrent or Metastatic Head and Neck Cancer: An Exploratory Analysis of Two Early-Phase Trials. Target Oncol. 2026 Aug 2. doi: 10.1007/s11523-026-01243-y. Online ahead of print. PMID 42542997