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Lung CancerPhase 1NCT07414953

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

A Phase 1 study testing HS-10504, SHR-A2009 and HS-20122 in people with Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Lung Cancer
What is being tested?
HS-10504, SHR-A2009 and HS-20122
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
30 Mar 2026to 30 Nov 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).
Show all 21Show fewer
  • 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.

About this study

Official title: 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).

Conditions
Lung Cancer
Being tested
HS-10504, SHR-A2009, HS-20122, HS-20117, SHR-1826
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-10504Drug

    HS-10504 administered orally every day

  • SHR-A2009Drug

    SHR-A2009 administered intravenously

  • HS-20122Drug

    HS-20122 administered intravenously

  • HS-20117Drug

    HS-20117 administered intravenously

  • SHR-1826Drug

    SHR-1826 administered intravenously

  • SHR-A2102Drug

    SHR-A2102 administered intravenously

Study groups in NCT07414953
Study groupRoleWhat they receive
Cohort 1aExperimentalNot described
Receives: Drug: HS-10504; Drug: SHR-A2102
Cohort 1bExperimentalNot described
Receives: Drug: HS-10504; Drug: SHR-A2009
Cohort 1cExperimentalNot described
Receives: Drug: HS-10504; Drug: HS-20122
Cohort 1dExperimentalNot described
Receives: Drug: HS-10504; Drug: HS-20117
Cohort 2ExperimentalNot described
Receives: Drug: HS-10504; Drug: SHR-1826

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Through the full duration of this trial, approximately 2 years

  2. ORR

    Investigator evaluated overall response rate, to evaluate the efficacy of each combination

    Measured: Through the full duration of this trial, approximately 2 years

  3. TEAE

    incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0

    Measured: Through the full duration of this trial, approximately 2 years

  4. TRAE

    incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0

    Measured: Through the full duration of this trial, approximately 2 years

  5. SAE

    incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0

    Measured: Through the full duration of this trial, approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2026
  2. Study start30 Mar 2026 (estimated)
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07414953
Sponsor's protocol ID
HS-10504-103
Status last verified
Feb 2026
First submitted
10 Feb 2026
Last updated
17 Feb 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-10504, SHR-A2009 and HS-20122 in people with Lung Cancer, run by Jiangsu Hansoh Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D for Combination (time frame: Through the full duration of this trial, approximately 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07414953.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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