ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors

NCT05276609
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Unknown
clinicaltrials.gov
Participants
177
clinicaltrials.gov
Lead sponsor
Shanghai Hansoh Biomedical Co., Ltd
clinicaltrials.gov
Start date
2021-11-28
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Summary
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in Chinese advanced solid tumor patients. This is a phase 1, open-label, multi-center, dose-escalation and expansion study evaluating the safety, tolerability, pharmacokinetic (PK), and the therapeutic potential of HS-20093 as a monotherapy in subjects with advanced solid tumors.
clinicaltrials.gov
Short title
ARTEMIS-001: Phase 1 Study of the HS-20093 in Patients With Advanced Solid Tumors
clinicaltrials.gov
Official title
ARTEMIS-001: A Phase 1, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Multiple Doses of Intravenous Administration of HS-20093 in Patients With Locally Advanced or Metastatic Solid Tumors Who Have Progressed Following Prior Therapy
clinicaltrials.gov

Control arm
Open label
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Unknown
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2023-12-31
clinicaltrials.gov
First posted
2022-03-11
clinicaltrials.gov
Registry last updated
2023-02-15
clinicaltrials.gov
Primary completion date
2023-12-31
clinicaltrials.gov
Start date
2021-11-28
clinicaltrials.gov

Participants
177
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
177
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
1
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Shanghai Hansoh Biomedical Co., Ltd
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05276609
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05276609
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Not randomised
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Ⅰa (Dose-Escalation Stage): Maximum tolerated dose (MTD) for HS-20093

    Timeframe: Up to day 21 from the first dose

    To determine the MTD for further evaluation of IV administration of HS-20093 in subjects with advanced solid tumors.

  2. Ⅰb (Dose-Expansion Stage): Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1

    Timeframe: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) and partial response (PR) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].

  1. Incidence and severity of adverse events (AEs)

    Timeframe: From the first dose through 90 days post end of treatment

    AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, physical examination, electrocardiogram, etc.

  2. Observed maximum plasma concentration (Cmax) of HS-20093 in participants with advanced solid tumor

    Timeframe: From pre-dose to 14 days after the first dose on Cycle 1

    Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle.

  3. Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose in participants with advanced solid tumor

    Timeframe: From pre-dose to 14 days after the first dose on Cycle 1

    Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle.

  4. Terminal half-life (T1/2) of HS-20093 following IV dose in participants with advanced solid tumor

    Timeframe: From pre-dose to 14 days after the first dose on Cycle 1

    Apparent terminal half-life is the time measured for the concentration to decrease by one half. Terminal half-life calculated by natural log 2 divided by λz.

  5. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093

    Timeframe: From pre-dose to 14 days after the first dose on Cycle 1

    Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

  6. Percentage of participants with antibodies to HS-20093 in serum

    Timeframe: From pre-dose to 90 days post end of treatment

    Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.

  7. ORR determined by investigators according to RECIST 1.1 (dose-escalation stage)

    Timeframe: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat).

  8. Duration of response (DOR) determined by investigators according to RECIST 1.1

    Timeframe: From the first dose up to PD or death, whichever came first, assessed up to 24 months

    DoR was defined as the period from the first occurrence of CR or PR to PD or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].

  9. Disease control rate (DCR) determined by investigators according to RECIST 1.1

    Timeframe: From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\].

  10. Progression-free survival (PFS) determined by investigators according to RECIST 1.1

    Timeframe: From the randomization/first dose up to PD or death, whichever came first, assessed up to 24 months

    Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to PD or death from any cause.

  11. Overall survival (OS) (only in dose expansion stage)

    Timeframe: From the randomization/first dose up to death, whichever came first, assessed up to 24 months

    OS was defined as the time from random assignment (dose expansion stage) or first dose (dose escalation stage) to death from any cause.

Sources for outcomes
clinicaltrials.gov

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

  1. At least age of 18 years at screening;
  2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable
  3. At least one extra-cranial measurable lesion according to RECIST 1
  4. Agree to provide fresh or archival tumor tissue
  5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
  6. Life expectancy >= 12 weeks
  7. Agree to use medically accepted methods of contraception
  8. Men or women should be using adequate contraceptive measures throughout the study;
  9. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential
  10. Signed and dated Informed Consent Form

Any of the following would exclude the subject from participation in the study:

  1. Treatment with any of the following:

    • Previous or current treatment with B7-H3 targeted therapy
    • Any cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093
    • Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093
    • Radiotherapy with a limited field of radiation for palliation within 2 weeks, or patients received more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first scheduled dose of HS-20093
    • Major surgery within 4 weeks prior to the first scheduled dose of HS-20093

  2. Subjects with previous or concurrent malignancies

  3. Inadequate bone marrow reserve or organ dysfunction

  4. Evidence of cardiovascular risk

  5. Evidence of current severe or uncontrolled systemic diseases

  6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093

  7. Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093

  8. Subjects with current infectious diseases

  9. History of neuropathy or mental disorders

  10. Pregnant or lactating female

  11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components of HS-20093

  12. Known vaccination or hypersensitivity of any level within 4 weeks prior to the first scheduled dose of HS-20093

  13. Unlikely to comply with study procedures, restrictions, and requirements in the opinion of the investigator

  14. Any disease or condition that, in the opinion of the investigator, would compromise subject safety or interfere with study assessments

Sources for eligibility
clinicaltrials.gov

  • Cancer Hospital Chinese Academy of Medical SciencesBeijing, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)