Clinical trial · Interventional
GH21 Capsules for Advanced Solid Tumors: A Study on Safety and Early Results
A Multicenter, Open-label Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Characteristics, and Preliminary Efficacy of GH21 Capsules in Subjects With Advanced Solid Tumors
NCT05183243CI-TRIAL-00078852unknownPhase 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)
Evaluate the safety and tolerability of GH21 in patients with advanced solid tumors. Estimate the maximum tolerated dose (MTD) in patients with advanced solid tumors.
Conditions
Conditions (5)
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 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Head and Neck Neoplasm | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GH21 Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy Dose Escalation.
- description
- Treatment with GH21 alone, conducted until disease progression, intolerance or end of study.
- interventionNames
- Drug: GH21 Capsule
Primary outcomes (2)
- measure
- Determination of Maximum Tolerated Dose (MTD) of GH21.
- timeFrame
- 28 Days
- description
- MTD is the highest dose of a treatment that does not cause unacceptable side effects.
- measure
- Characterize the Safety of GH21
- timeFrame
- Approximately 3 years
- description
- Number of participants with treatment-emergent adverse events and serious AEs.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Male or female subjects greater than or equal to 18 years old； 2. Written informed consent obtained prior to any study-related procedure being performed; 3. Subjects with life expectancy ≥3 months; 4. Eastern Cooperative Oncology Group performance score 0 - 2; 5. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor; 6. At least one measurable lesion based on RECIST version 1.1 . Exclusion Criteria: 1. History of other malignancies within 3 years before screening,unless radical non-melanoma skin cancer or basal cell carcinoma of the skin or carcinoma in the situ of the cervix; 2. Have central nervous system metastases; 3. Prior treatment with SHP2 inhibitor; 4. Have major surgery within 28 days prior to the first dose of GH21; 5. Left ventricular ejection fraction (LVEF) \<50 %; 6. Females who are pregnant or breastfeeding ; 7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; 8. Conditions that the investigator considers inappropriate for participation in this clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.