A Study of HS-10529 in KRAS G12D Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HS-10529.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 1 Study, Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-10529 Monotherapy in KRAS G12D Patients With Advanced Solid Tumors
Overview
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.
Detailed description
This is a phase 1, first-in-human, study of HS-10529, consisting of dose escalation and dose expansion, which is aimed to assess the safety and tolerability of HS-10529 in KRAS G12D patients with advanced solid tumors and evaluate the preliminary efficacy of HS-10529.
Interventions
- Drug HS-10529
Participants in all subjucts will receive HS-10529
Primary outcome measures
- The maximum tolerated dose (MTD) or maximum applicable dose (MAD) [Time frame: up to 24 months]
Secondary outcome measures (2)
- Incidence and severity of treatment-emergent adverse events [Time frame: up to 24 months]
- Plasma concentration of HS-10529 [Time frame: up to 36 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06963398 · HS-10529-101