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OsteosarcomaPhase 1NCT06699576

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

A Phase 1 study testing HS-20093, Anlotinib and Epirubicin in people with Osteosarcoma and Soft Tissue Sarcoma (STS), run by Hansoh BioMedical R&D Company.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Osteosarcoma, Soft Tissue Sarcoma (STS)
What is being tested?
HS-20093, Anlotinib and Epirubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
448 participants
Where
No sites listed yet
Study dates
20 Dec 2024to 30 Dec 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At least age of 18 years at screening;
  • Histologically or cytologically confirmed, locally advanced or metastatic osteosarcoma and soft tissue sarcoma
  • 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.
  • 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
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  • 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

Who cannot join

  • treatment with any of the following:
  • Previous or current treatment with B7-H3 targeted therapy
  • Previous or current treatment with TOP1i related treatment
  • Previous or current treatment with PD-L1 inhibitor (Cohort2 )
  • Intolerable for any Anlotinib(Cohort 1a/1c), Anthracyclines (Cohort 1b/1c) and PD-L1 inhibitor (Cohort2 )
  • Cytotoxic chemotherapy, investigational agents and anticancer drugs within 14 days prior to the first scheduled dose of HS-20093
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  • 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
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaodong Tang, PhD contact

010-88324561

tang15877@126.com

About this study

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.

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.

Read the detailed description

This is a phase 1b, open-label, multi-center, dose-escalation and expansion study in subjects with advanced bone and soft tissue sarcoma. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents.

A total of 4 combination-treatments will be carried out in 2 cohorts. The target population in cohort 1 of dose escalation part is soft tissue sarcoma patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease. The target population in cohort 2 will enroll patients with osteosarcoma have progressed on or intolerant to available standard therapies All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of study drug. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists

Being tested
HS-20093, Anlotinib, Epirubicin, Adebrelimab
Keywords
Phase 1b, Osteosarcoma, Soft Tissue Sarcoma, HS-20093, B7-H3
Medical subject headings
Osteosarcoma, Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HS-20093Drug

    HS-20093: administered as an IV infusion

  • AnlotinibDrug

    Anlotinib: 12mg once daily (QD) orally

  • EpirubicinDrug

    Epirubicin: administered as an IV infusion

  • AdebrelimabDrug

    Adebrelimab: administered as an IV infusion

Study groups in NCT06699576
Study groupRoleWhat they receive
Cohort 1aExperimentalHS-20093 and Anlotinib
Receives: Drug: HS-20093; Drug: Anlotinib
Cohort 1bExperimentalHS-20093 and Epirubicin
Receives: Drug: HS-20093; Drug: Epirubicin
Cohort 1cExperimentalHS-20093, Epirubicin and Anlotinib
Receives: Drug: HS-20093; Drug: Anlotinib; Drug: Epirubicin
Cohort 2aExperimentalHS-20093 and Adebrelimab
Receives: Drug: HS-20093; Drug: Adebrelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum tolerated dose (MTD) for combination-treatments

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

    Measured: Up to day 21 from the first dose

Secondary outcomes (10)

  1. Objective response rate (ORR) determined by investigators

    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).

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

  2. Disease control rate (DCR) determined by investigators

    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].

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

  3. Duration of response (DoR) determined by investigators

    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)].

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

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

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

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

  5. Overall survival (OS)

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

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

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

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

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

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

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

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

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

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

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

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

    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.

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2024
  2. Study start20 Dec 2024 (estimated)
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
448 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06699576
Sponsor's protocol ID
HS-20093-106
Status last verified
Nov 2024
First submitted
19 Nov 2024
Last updated
21 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing HS-20093, Anlotinib and Epirubicin in people with Osteosarcoma and Soft Tissue Sarcoma (STS), run by Hansoh BioMedical R&D Company.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaodong Tang, PhD (010-88324561, tang15877@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) for combination-treatments (time frame: Up to day 21 from the first dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06699576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.

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