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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: HS-10504; Drug: SHR-A2102; Drug: SHR-A2009; Drug: HS-20122; Drug: HS-20117; Drug: SHR-1826

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 2	Drug: HS-10504; HS-10504 administered orally every day; Drug: SHR-1826; SHR-1826 administered intravenously
Experimental: Cohort 1a	Drug: HS-10504; HS-10504 administered orally every day; Drug: SHR-A2102; SHR-A2102 administered intravenously
Experimental: Cohort 1b	Drug: HS-10504; HS-10504 administered orally every day; Drug: SHR-A2009; SHR-A2009 administered intravenously
Experimental: Cohort 1c	Drug: HS-10504; HS-10504 administered orally every day; Drug: HS-20122; HS-20122 administered intravenously
Experimental: Cohort 1d	Drug: HS-10504; HS-10504 administered orally every day; Drug: HS-20117; HS-20117 administered intravenously

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RP2D for Combination	To evaluate the potent and tolerated of combination(s) and dosage(s) of HS-10504 based therapy in subjects with EGFR mutation-positive locally advanced or metastatic NSCLC who have experienced disease progression on or after prior treatment, which suitable for a Phase II trial	Through the full duration of this trial, approximately 2 years
ORR	Investigator evaluated overall response rate, to evaluate the efficacy of each combination	Through the full duration of this trial, approximately 2 years
TEAE	incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0	Through the full duration of this trial, approximately 2 years
TRAE	incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0	Through the full duration of this trial, approximately 2 years
SAE	incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0	Through the full duration of this trial, approximately 2 years

Collaborators and Investigators

• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Estimated): March 30, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): November 30, 2028

Study Registration Dates

• First Submitted: February 10, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: HS-10504-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No