Clinical trial · Interventional
A Study of HS-10529 in KRAS G12D Patients With Advanced Solid Tumors
A Phase 1 Study, Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10529 Monotherapy in KRAS G12D Patients With Advanced Solid Tumors
NCT06963398CI-TRIAL-00089506not yet recruitingPhase 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)
HS-10529 is an oral, highly selective, small molecular inhibitor of KRAS G12D. This study will evaluate the safety, tolerability, pharmacokinetics and clinical activity of HS-10529 in KRAS G12D patients with 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 | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-10529 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS-10529
- interventionNames
- Drug: HS-10529
Primary outcomes (1)
- measure
- The maximum tolerated dose (MTD) or maximum applicable dose (MAD)
- timeFrame
- up to 24 months
Secondary outcomes (2)
- measure
- Incidence and severity of treatment-emergent adverse events
- timeFrame
- up to 24 months
- measure
- Plasma concentration of HS-10529
- timeFrame
- up to 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * At least age of 18 years at screening. * Patients of advanced solid tumor，who have progressed on or intolerant to standard therapy. * With measurable lesion according to RECIST 1.1. * Agree to provide fresh or archival tumor tissue. * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1. Exclusion Criteria: * Previous or current treatment with KRAS G12D inhibitors. * Uncontrolled pleural, ascites or pericardial effusion. * Known and untreated, or active central nervous system metastases. * History of other primary malignant tumors. * Serious, uncontrolled, or active comorbidities. * Refractory nausea, vomiting, or chronic gastrointestinal diseases, or inability to swallow oral medications.
References
Publications (0)
Data not yet available
No reference posted for this study.