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

NCT07645222 | Not Yet Recruiting Phase 1

• 1 other identifier: HS-20122-103
• Study Type: interventional
• Target: 396
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Lung Cancer

Keywords

Lung cancer; Tyrosine Kinase Inhibitor; Immuno-Checkpoint Inhibitor; Antibody Drug Conjugate

Outcome Measures

Primary Outcomes (5)

• 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；

• SAE

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

  Through the full duration of this trial, approximately 2 years

Secondary Outcomes (6)

• Duration of Response

  Through the full duration of this trial ,approximately 2 years

• Disease Control Rate

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

• Progression Free Survival

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

• Overall Survival

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

• PK parameter

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

Study Arms (3)

HS-20122+Aumolertinib

EXPERIMENTAL

Drug: HS-20122+Aumolertinib

HS-20122+Adbrelimab

EXPERIMENTAL

Drug: HS-20122+Adbrelimab

HS-20122+Adbrelimab+Platinum-based Chemo

EXPERIMENTAL

Drug: HS-20122+Adbrelimab+Platinum-based Chemo

Interventions

HS-20122+Adbrelimab DRUG

EGFRwt NSCLC,receive HS-20122+Adbrelimab

HS-20122+Adbrelimab

HS-20122+Aumolertinib DRUG

EGFR mut NSCLC, receive HS-20122+Aumolertinib

HS-20122+Aumolertinib

HS-20122+Adbrelimab+Platinum-based Chemo DRUG

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

HS-20122+Adbrelimab+Platinum-based Chemo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hansoh BioMedical R&D Company: lead

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 12, 2026
• Study Start (Estimated): June 30, 2026
• Primary Completion (Estimated): October 31, 2028
• Study Completion (Estimated): April 30, 2029
• Last Updated: June 12, 2026

Record last verified: 2026-06