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AzTrials

Lung CancerPhase 1NCT07645222

PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC

A Phase 1 study testing HS-20122+Aumolertinib, HS-20122+Adbrelimab and HS-20122+Adbrelimab+Platinum-based Chemo in people with Lung Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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-20122 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-20122+Aumolertinib, HS-20122+Adbrelimab and HS-20122+Adbrelimab+Platinum-based Chemo
Could I receive a placebo?
No, everyone receives an active treatment
How many people
396 participants
Where
1 siteChina
Study dates
15 Jun 2026to 30 Apr 2029
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

  • Locally advanced or metastastic NSCLC;
  • Received at least 1 line SoC,or treatment naïve;
  • 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 20Show 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,
  • Prensence of ophthalmological abnormalities.
  • 17.Presence of hepatic encephalopathy, Hepato-renal Syndrome 18.Presence or history of confirmed or suspected ILD; 19.Prior history of significant neurological or mental disorders, including conditions that interfere with assessment, such as epilepsy, dementia, or major depressive disorder.
  • 20.History of severe allergy, or history of hypersensitivity to any active or inactive ingredient of investigational drugs.
  • 21.Presence of any conditions that jeopardize subject safety or interfere with study assessments as judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Ethics Committee of Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

    Ran Xu, MD, 86-20-87343009, llwyh@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A PHASE Ib STUDY OF THE SAFETY, EFFICACY, PHARMACOKINETICS, AND IMMUNOGENICITY OF HS-20122 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-20122 combined therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC).

Read the detailed description

This is a multi-center, open-label, phase I study to evaluate the safety, efficacy, pharmacokinetics (PK), and immunogenicity of HS-20122 combination therapy in subjects with locally advanced or metastatic non-small cell lung cancer (NSCLC). A dose exploration stage of each combination therapy will be conducted in subjects with advanced or metastatic NSCLC patients who experienced disease progression (PD) on or after prior treatments, to explore appropriate doses. In addition, an dose-expansion stage will be conducted in appropriate target populations based on the data obtained in the dose exploration stage to further explore the safe and efficacy.

Conditions
Lung Cancer
Being tested
HS-20122+Aumolertinib, HS-20122+Adbrelimab, HS-20122+Adbrelimab+Platinum-based Chemo
Keywords
Lung cancer, Tyrosine Kinase Inhibitor, Immuno-Checkpoint Inhibitor, Antibody Drug Conjugate
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-20122+AumolertinibDrug

    EGFR mut NSCLC, receive HS-20122+Aumolertinib

  • HS-20122+AdbrelimabDrug

    EGFRwt NSCLC,receive HS-20122+Adbrelimab

  • HS-20122+Adbrelimab+Platinum-based ChemoDrug

    EGFR wt NSCLC,receive HS-20122+Adbrelimab+ Platinum-based Chemo

Study groups in NCT07645222
Study groupRoleWhat they receive
HS-20122+AumolertinibExperimentalNot described
Receives: Drug: HS-20122+Aumolertinib
HS-20122+AdbrelimabExperimentalNot described
Receives: Drug: HS-20122+Adbrelimab
HS-20122+Adbrelimab+Platinum-based ChemoExperimentalNot described
Receives: Drug: HS-20122+Adbrelimab+Platinum-based Chemo

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-20122 based therapy in subjects with 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

Secondary outcomes (6)

  1. Duration of Response

    Investigator evaluated Duration of Response

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

  2. Disease Control Rate

    Investigator evaluated Disease Control Rate

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

  3. Progression Free Survival

    Investigator evaluated duration of Progression Free Survival

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

  4. Overall Survival

    Investigator evaluated duration of Overall Survival

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

  5. PK parameter

    blood concentration of combo agents

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

  6. Immuogencity

    positive rate of drug specific antibody

    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 posted12 Jun 2026
  2. Study start15 Jun 2026
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion30 Apr 2029 (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
396 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07645222
Sponsor's protocol ID
HS-20122-103
Status last verified
Jul 2026
First submitted
8 Jun 2026
Last updated
6 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20122+Aumolertinib, HS-20122+Adbrelimab and HS-20122+Adbrelimab+Platinum-based Chemo in people with Lung Cancer, run by Hansoh BioMedical R&D Company at 1 site in China.

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 20 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: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Each site lists its own contact: choose the nearest one under Trial locations. 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 NCT07645222.

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 6 Jul 2026.

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