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

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).

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Drug: HS-20122+Aumolertinib; Drug: HS-20122+Adbrelimab; Drug: HS-20122+Adbrelimab+Platinum-based Chemo

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.

• Study Type: Interventional
• Enrollment (Estimated): 396
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Ethics Committee of Sun Yat-sen University Cancer Center
      • Contact: Ran Xu, MD; Phone Number: 86-20-87343009; Email: llwyh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Locally advanced or metastastic NSCLC;
2. Received at least 1 line SoC,or treatment naïve;
3. With at least 1 target lesion according to RECIST 1.1.
4. Appropriate organ function
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-1 and no deterioration within 2 weeks prior to the first dose.
6. Minimum expected survival longer than 12 weeks
7. 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.
8. Voluntarily participate in this clinical trial, understand the study procedures, and be able to sign written informed consent form.

Exclusion Criteria:

1. Insufficient wash out duration of prior systemic anticancer therapy
2. Local radiotherapy within 2 weeks prior to first dose of investigational drug
3. Pleural/abdominal effusion requires clinical intervention
4. Major surgery within 4 weeks prior to first dose of investigational drug
5. History of drugs may prolong QT interval
6. 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).
7. Presence of brain metastasis or carcinomatous meningtitis
8. History of other primary malignancies
9. Significant, uncontrolled, or active cardiovascular diseases
10. Severe or poorly controlled diabetes
11. Extremely obesity or emaciation
12. Clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose
13. Severe arteriovenous thrombotic events (e.g., deep venous thrombosis, pulmonary embolism) within 3 months prior to the first dose
14. Severe infection within 4 weeks
15. History of systemic glucocorticoids over 28 days prior to first dose of investigational drug
16. Presence of known active infectious diseases,
17. 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.

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

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HS-20122+Aumolertinib	Drug: HS-20122+Aumolertinib; EGFR mut NSCLC, receive HS-20122+Aumolertinib
Experimental: HS-20122+Adbrelimab	Drug: HS-20122+Adbrelimab; EGFRwt NSCLC,receive HS-20122+Adbrelimab
Experimental: HS-20122+Adbrelimab+Platinum-based Chemo	Drug: HS-20122+Adbrelimab+Platinum-based Chemo; EGFR wt NSCLC,receive HS-20122+Adbrelimab+ Platinum-based Chemo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SAE	incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0	Through the full duration of this trial, approximately 2 years
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	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；

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Response	Investigator evaluated Duration of Response	Through the full duration of this trial ,approximately 2 years
Disease Control Rate	Investigator evaluated Disease Control Rate	Through the full duration of this trial ,approximately 2 years；
Progression Free Survival	Investigator evaluated duration of Progression Free Survival	Through the full duration of this trial, approximately 2 years；
Overall Survival	Investigator evaluated duration of Overall Survival	Through the full duration of this trial ,approximately 2 years；
PK parameter	blood concentration of combo agents	Through the full duration of this trial, approximately 2 years；
Immuogencity	positive rate of drug specific antibody	Through the full duration of this trial ,approximately 2 years；

Collaborators and Investigators

• Sponsor: Hansoh BioMedical R&D Company

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): April 30, 2029

Study Registration Dates

• First Submitted: June 8, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Lung cancer; Antibody Drug Conjugate; Tyrosine Kinase Inhibitor; Immuno-Checkpoint Inhibitor
• 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-20122-103

Drug and device information, study documents

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