Clinical trial · Interventional
GH35 Tablets for Advanced Solid Tumors: A Study on Safety and Early Results
A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Antitumor Activity of GH35 Tablets in Patients Harboring With G12C Mutation in Advanced Solid Tumors
NCT05010694CI-TRIAL-00078609unknownPhase 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 GH35 in patients with KRAS mutant advanced solid tumors. Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in patients with KRAS mutant 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 |
|---|---|---|---|
| Advanced Solid Tumors Harboring With G12C Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GH35 Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Monotherapy Dose Escalation.
- description
- Treatment with GH35 alone, conducted until disease progression, intolerance or end of study.
- interventionNames
- Drug: GH35 Tablet
Primary outcomes (1)
- measure
- Dose-limiting toxicities (DLT)
- timeFrame
- 24 Days
- description
- Number of participants with dose limiting toxicities (DLTs)
Secondary outcomes (6)
- measure
- Characterize the safety of GH35 in subjects
- timeFrame
- 30 Months
- description
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. Histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with KRAS mutation identified. 3. Expected survival time ≥12 weeks. 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 5. Must have at least one measureable lesion per Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. 6. Have documented disease progression or intolerance after first-line treatment. Exclusion Criteria: 1. Gastrointestinal (GI) tract disease causing the inability to take oral medication. 2. Previous accept with KRAS G12C inhibitor. 3. Uncontrollable general infection. 4. Serious cardiovascular disease. 5. Left ventricular ejection fraction (LVEF) \<50 %. 6. Known history of hypersensitivity to any of the excipients of GH35 tablets 7. Pregnant or nursing (lactating) women.
References
Publications (0)
Data not yet available
No reference posted for this study.