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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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