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

Phase
Recruitment status
Participants
Lead sponsor
Hansoh BioMedical R&D Company
Start date
Number of sites

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
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Hansoh BioMedical R&D Company
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design

  1. 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

  2. ORR

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

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

  3. 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

  4. 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

  5. SAE

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

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

  1. Duration of Response

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

    Investigator evaluated Duration of Response

  2. Disease Control Rate

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

    Investigator evaluated Disease Control Rate

  3. Progression Free Survival

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

    Investigator evaluated duration of Progression Free Survival

  4. Overall Survival

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

    Investigator evaluated duration of Overall Survival

  5. PK parameter

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

    blood concentration of combo agents

  6. Immuogencity

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

    positive rate of drug specific antibody

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No

  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.

  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.

Sources for eligibility

  • Ethics Committee of Sun Yat-sen University Cancer CenterGuangzhou, ChinaRecruiting
Sources for sites

Related records

Drugs (2)

Lead sponsors (1)

Conditions (2)

Targets (1)