ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.

NCT06699576
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Phase
Phase 1
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Recruitment status
Not yet recruiting
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Participants
448
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Lead sponsor
Hansoh BioMedical R&D Company
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Start date
2024-12-20
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Summary
HS-20093 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on bone and soft tissue sarcoma. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced bone and soft tissue sarcoma.
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Short title
ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma.
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Official title
ARTEMIS-103: a Phase 1b, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of HS-20093 in Combination with Other Anti-cancer Agents in Patients with Bone and Soft Tissue Sarcoma.
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Not yet recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2028-12-30
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First posted
2024-11-21
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Registry last updated
2024-11-21
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Primary completion date
2026-12-30
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Start date
2024-12-20
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Participants
448
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Participant count basis
Estimated
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Planned participants
448
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Protocol amendments
0
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Hansoh BioMedical R&D Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06699576
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ClinicalTrials.gov ID
NCT06699576
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Registry record
Open registry record
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Allocation
Not applicable
Model
Sequential
Purpose
Treatment
Masking
No masking
Sources for study design
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  1. Maximum tolerated dose (MTD) for combination-treatments

    Timeframe: Up to day 21 from the first dose

    To determine the MTD for further evaluation of HS-20093 with other anti-cancer agents in subjects with advanced bone and soft tissue sarcoma.

  1. Objective response rate (ORR) determined by investigators

    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. 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).

  2. Disease control rate (DCR) determined by investigators

    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. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\].

  3. Duration of response (DoR) determined by investigators

    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 \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].

  4. Progression-free survival (PFS) 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

    PFS was defined as the time from random assignment or first dose to PD or death from any cause

  5. Overall survival (OS)

    Timeframe: From the first dose up to death, assessed up to 24 months

    OS was defined as the time from random assignment or first dose to death from any cause.

  6. Observed maximum plasma concentration (Cmax) of HS-20093

    Timeframe: From pre-dose to study completion, assessed up to 24 months

    Cmax will be obtained after administration of the first dose of HS-20093

  7. Time to reach maximum plasma concentration (Tmax) of HS-20093

    Timeframe: From pre-dose to study completion, assessed up to 24 months

    Tmax will be obtained after administration of the first dose of HS-20093

  8. Terminal half-life (T1/2) of HS-20093 following the first dose

    Timeframe: From pre-dose to study completion, assessed up to 24 months

    T1/2will be obtained after administration of the first dose of HS-20093

  9. 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 study completion, assessed up to 24 months

    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.

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

    Timeframe: From pre-dose to study completion, assessed up to 24 months

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

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

  • At least age of 18 years at screening;

  • Histologically or cytologically confirmed, locally advanced or metastatic osteosarcoma and soft tissue sarcoma

    1. Cohort1: Dose escalation part will enroll advanced soft tissue sarcoma for which standard treatment has proven ineffective or unavailable or intolerable. Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
    2. Cohort2: Advanced osteosarcoma patients for which standard treatment has proven ineffective or unavailable or intolerable.

  • least one extra-cranial measurable lesion according to RECIST 1

  • Agree to provide fresh or archival tumor tissue

  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1

  • Life expectancy >= 12 weeks

  • Agree to use medically accepted methods of contraception

  • Men or women should be using adequate contraceptive measures throughout the study;

  • Females subjects must not be pregnant at screening or have evidence of non-childbearing potential

  • Signed and dated Informed Consent Form

  • treatment with any of the following:

    1. Previous or current treatment with B7-H3 targeted therapy
    2. Previous or current treatment with TOP1i related treatment
    3. Previous or current treatment with PD-L1 inhibitor (Cohort2 )
    4. Intolerable for any Anlotinib(Cohort 1a/1c), Anthracyclines (Cohort 1b/1c) and PD-L1 inhibitor (Cohort2 )
    5. Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093
    6. Prior treatment with a monoclonal antibody within 28 days prior to the first scheduled dose of HS-20093
    7. 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
    8. Major surgery within 4 weeks prior to the first scheduled dose of HS-20093

  • Subjects with previous or concurrent malignancies

  • Inadequate bone marrow reserve or organ dysfunction

  • Evidence of cardiovascular risk

  • Evidence of current severe or uncontrolled systemic diseases

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

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

  • Subjects with current infectious diseases

  • History of neuropathy or mental disorders

  • Pregnant or lactating female

  • 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

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

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

Sources for eligibility
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Related records

Drugs (3)

Lead sponsors (1)

Conditions (3)

Targets (5)