A Phase Ib Study of HS-10504 Combined Therapy in NSCLC

February 14, 2026 updated by: Jiangsu Hansoh Pharmaceutical Co., Ltd.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: Through the full duration of this trial, approximately 2 years
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
Time Frame: Through the full duration of this trial, approximately 2 years
Investigator evaluated overall response rate, to evaluate the efficacy of each combination
Through the full duration of this trial, approximately 2 years
TEAE
Time Frame: Through the full duration of this trial, approximately 2 years
incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0
Through the full duration of this trial, approximately 2 years
TRAE
Time Frame: Through the full duration of this trial, approximately 2 years
incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0
Through the full duration of this trial, approximately 2 years
SAE
Time Frame: Through the full duration of this trial, approximately 2 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Jiangsu Hansoh Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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