PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC
- 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).
- Short title
- PHASE 1b STUDY OF HS-20122 COMBINED THERAPY IN NSCLC
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Completion date
- 2029-04-30
- First posted
- 2026-06-12
- Registry last updated
- 2026-07-06
- Primary completion date
- 2028-10-31
- Start date
- 2026-06-15
- Participants
- Participant count basis
- Estimated
- Planned participants
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Hansoh BioMedical R&D Company
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07645222
- ClinicalTrials.gov ID
- NCT07645222
- Registry record
- Open registry record
- Allocation
- Not randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
RP2D for Combination
Timeframe: Through the full duration of this trial, approximately 2 years
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
ORR
Timeframe: Through the full duration of this trial, approximately 2 years;
Investigator evaluated overall response rate, to evaluate the efficacy of each combination;
TEAE
Timeframe: Through the full duration of this trial, approximately 2 years;
incidence of Investigator evaluated Treatment Emerged Adverse Events, graded per CTCAE V5.0
TRAE
Timeframe: Through the full duration of this trial, approximately 2 years;
incidence of Investigator evaluated Treatment Related Adverse Events, graded per CTCAE V5.0
SAE
Timeframe: Through the full duration of this trial, approximately 2 years
incidence of Investigator evaluated Severe Adverse Events, graded per CTCAE V5.0
Duration of Response
Timeframe: Through the full duration of this trial ,approximately 2 years
Investigator evaluated Duration of Response
Disease Control Rate
Timeframe: Through the full duration of this trial ,approximately 2 years;
Investigator evaluated Disease Control Rate
Progression Free Survival
Timeframe: Through the full duration of this trial, approximately 2 years;
Investigator evaluated duration of Progression Free Survival
Overall Survival
Timeframe: Through the full duration of this trial ,approximately 2 years;
Investigator evaluated duration of Overall Survival
PK parameter
Timeframe: Through the full duration of this trial, approximately 2 years;
blood concentration of combo agents
Immuogencity
Timeframe: Through the full duration of this trial ,approximately 2 years;
positive rate of drug specific antibody
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Healthy volunteers
- No
- 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.
- 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,
- 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.
- Ethics Committee of Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
Related records
Drugs (2)
Lead sponsors (1)
Conditions (2)
- Lung cancer Primary condition
- Lung neoplasm