Clinical trial · Interventional
A Phase Ib Study of HS-10504 Combined Therapy in NSCLC
A Phase Ib Study of the Safety, Efficacy, Pharmacokinetics, and Immunogenicity of HS-10504 Combined Therapy in Advanced Non-small Cell Lung Cancer Patients
NCT07414953CI-TRIAL-00103427not 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)
This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-10504 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-10504 | Drug | — | UNRESOLVED |
| HS-20117 | Drug | — | UNRESOLVED |
| HS-20122 | Drug | — | UNRESOLVED |
| SHR-1826 | Drug | — | UNRESOLVED |
| SHR-A2009 | Drug | — | UNRESOLVED |
| SHR-A2102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- Cohort 1a
- interventionNames
- Drug: HS-10504
- Drug: SHR-A2102
- type
- EXPERIMENTAL
- label
- Cohort 1b
- interventionNames
- Drug: HS-10504
- Drug: SHR-A2009
- type
- EXPERIMENTAL
- label
- Cohort 1c
- interventionNames
- Drug: HS-10504
- Drug: HS-20122
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Cohort1:participants with EGFR mutation advanced stage NSCLC,disease progression on or after prior treatment; * Cohort2:participants with MET position advanced stage NSCLC,disease progression on or after prior treatment; * With at least 1 target lesion according to RECIST 1.1. * Appropriate organ function * Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose. * Minimum expected survival longer than 12 weeks * Female subjects of childbearing potential are willing to take appropriate contraceptive measures and should not breastfeed from signing the informed consent form (ICF) through 6 months after the last dose; male subjects are willing to use barrier contraception (i.e., condom) from signing the ICF through 6 months after the last dose. * Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form. Exclusion Criteria: * Insufficient wash out duration of prior systemic anticancer therapy * Local radiotherapy within 2 weeks prior to first dose of investigational drug * Pleural/abdominal effusion requires clinical intervention * Major surgery within 4 weeks prior to first dose of investigational drug * History of drugs may prolong QT interval * Have any grade ≥ 2 residual toxicity according to Common Terminology Criteria for Adverse Events (CTCAE, version 5.0) from prior anti-tumor therapy (except alopecia and residual neurotoxicity). * Presence of brain metastasis or carcinomatous meningtitis * History of other primary malignancies * Significant, uncontrolled, or active cardiovascular diseases * Severe or poorly controlled diabetes * Extremely obesity or emaciation * Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose * Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose * Severe infection within 4 weeks * History of systemic glucocorticoids over 28 days prior to first dose of investigational drug * Presence of known active infectious diseases, * Presence of hepatic encephalopathy, Hepantorenal Syndrome * Presence or history of confirmed or suspected ILD; * Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder. * Past history of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs. * Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.