OsteosarcomaPhase 2NCT05830123
ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
A Phase 2 study testing HS-20093 in people with Osteosarcoma and Sarcoma, run by Hansoh BioMedical R&D Company at 11 sites in China.
Trial 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. This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteosarcoma, Sarcoma
- What is being tested?
- HS-20093
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 11 sitesChina
- Study dates
- 8 Jun 2023to 31 Dec 2027
- Phase
- Phase 2
- 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;
- Patients with histologically confirmed relapsed or refractory osteosarcoma or other sarcomas who have progressed upon first-line systemic treatment.
- At least one measurable lesion according to RECIST 1.1.
- Agree to provide fresh or archival tumor tissue and peripheral blood samples.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
- Life expectancy >= 12 weeks
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- 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
- 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
- Pleural or peritoneal effusion requiring clinical intervention. Pericardial effusion.
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- Major surgery within 4 weeks of the first dose of HS-20093.
- Spinal cord compression or brain metastases.
- Treatment with drugs that are predominantly CYP3A4 strong inhibitors or inducers or sensitive substrates of CYP3A4 with a narrow therapeutic range within 7 days of the first dose of study drug; or requiring treatment with these drugs during the study.
- Currently receiving drugs known to prolong QT interval or may cause torsade de pointe; or requiring treatment with these drugs during the study.
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk.
- Severe, uncontrolled or active cardiovascular diseases.
- Diabetes ketoacidosis or hyperglycemia hypertonic occurring within 6 months before the first dose of the study drug, or the glycosylated hemoglobin value ≥ 7.5% in the screening period.
- Severe or poorly controlled hypertension.
- Bleeding symptoms with apparent clinical significance or obvious bleeding tendency within 1 months prior to the first dose of HS-20093
- Serious arteriovenous thrombosis events occurred within 3 months before the first dose.
- Severe infections occurred within 4 weeks before the first dose.
- Patients who have received continuous steroid treatment for more than 30 days within 30 days before the first dose, or need long-term (≥ 30 days) steroid treatment, or who have other acquired and congenital immunodeficiency diseases, or have a history of organ transplantation
- The presence of active infectious diseases has been known before the first dose such as hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency virus HIV infection, etc.
- Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe cirrhosis.
- Other moderate or severe lung diseases that may interfere with the detection or treatment of drug-related pulmonary toxicity or may seriously affect respiratory function.
- Previous history of serious neurological or mental disorders, including epilepsy, dementia or severe depression and any other status that may interfere in assessment.
- Women who are breastfeeding or pregnant or planned to be pregnant during the study period.
- Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose of HS-20093
- History of severe hypersensitivity reaction, severe infusion reaction or allergy to recombinant human or mouse derived proteins.
- Hypersensitivity to any ingredient 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
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Peking University People's Hospital
Beijing
- Recruiting
Hunan Cancer Hospital
Changsha
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou
jin Wang
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
- Recruiting
Chinese PLA General Hospital of Eastern Theater Command
Nanjing
- Recruiting
Shanghai 6th People's Hospital
Shanghai
- Recruiting
Shanghai General Hospital
Shanghai
- Recruiting
Tianjin Cancer Hospital
Tianjin
- Recruiting
Henan Cancer Hospital
Zhengzhou
About this study
Official title: ARTEMIS-002: A Phase 2, Multicenter, Open-label Study of Intravenous Administration of HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
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.
This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with relapsed or refractory osteosarcoma and other sarcomas.
Read the detailed description
This is a phase 2, open-label, multi-center study consisting of two parts: Phase 2a and 2b.
Phase 2a: The study will be conducted in the following two cohorts: Cohort 1: Patients with advanced osteosarcoma upon disease progression after standard treatment. Cohort 2: Patients with other unresectable bone and soft tissue sarcomas, if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. Subjects will be randomly assigned in a 1:1 ratio to 8.0 mg/kg and 12.0 mg/kg of HS-20093 in cohort 1 and will receive 12.0 mg/kg in cohort 2.
Phase 2b: The study will be conducted in patients with advanced osteosarcoma upon disease progression after standard treatment. Subjects will receive HS-20093 at the recommended dose from Phase 2a.
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.
- Conditions
- Osteosarcoma, Sarcoma
- Being tested
- HS-20093
- 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
IV administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression.
| Study group | Role | What they receive |
|---|---|---|
| cohort 1 at HS-20093 8mg/kg (Phase 2a) | Experimental | Participants in cohort 1 will be randomized to receive HS-20093 at 8 mg/kg. Receives: Drug: HS-20093 |
| cohort 1 at HS-20093 12mg/kg (Phase 2a) | Experimental | Participants in cohort 1 will be randomized to receive HS-20093 at 12 mg/kg. Receives: Drug: HS-20093 |
| cohort 2 at HS-20093 12mg/kg (Phase 2a) | Experimental | Participants in cohort 2 will receive HS-20093 at 12 mg/kg. Receives: Drug: HS-20093 |
| HS-20093(Phase 2b) | Experimental | Participants will receive HS-20093 at the recommended dose from Phase 2a. Receives: Drug: HS-20093 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Secondary outcomes (12)
Incidence and severity of adverse events (AEs)
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.
Measured: From the first dose through 90 days post end of treatment.
Observed maximum plasma concentration (Cmax) of HS-20093
Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle.
Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose
Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle.
Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Terminal half-life (T1/2) of HS-20093 following the first dose
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.
Measured: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
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 14 days after the first dose on Cycle 1 (each cycle is 21 days)
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 90 days post end of treatment
ORR determined by Independent review committee (IRC) according to RECIST 1.1
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by IRC based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Duration of response (DoR) determined by investigators and IRC according to RECIST 1.1
DoR was defined as the period from the first occurrence of CR or PR to progressive disease (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 disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Disease control rate (DCR) determined by investigators and IRC according to RECIST 1.1.
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].
Measured: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Progression-free survival (PFS) determined by investigators and IRC according to RECIST 1.1
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 first dose or random assignment (if any) to PD or death from any cause.
Measured: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
4-month PFS rate determined by investigators and IRC according to RECIST 1.1
4-month PFS rate is defined as the percentage of patients whose disease is progression free at 4 months from the start of treatment.
Measured: 4 months.
Overall survival (OS)
OS was defined as the time from the first dose or random assignment (if any) to death from any cause.
Measured: From the first dose or random assignment up to death or withdrawal from study, whichever came first, 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.
- First posted26 Apr 2023
- Study start8 Jun 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteosarcomaStudies of the same condition, open and under way.
- More trials run by Hansoh BioMedical R&D CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hansoh BioMedical R&D Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wei Guo, MD, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830123
- Sponsor's protocol ID
- HS-20093-201
- Status last verified
- Aug 2024
- First submitted
- 3 Apr 2023
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARTEMIS-002: A Phase 2, Multicenter, Open-label Study of Intravenous Administration of HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
- ClinicalTrials.gov ID
- NCT05830123
- Acronym / sponsor ID
- HS-20093-201
- Conditions
- Osteosarcoma, Sarcoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Hansoh BioMedical R&D CompanyIndustry (pharma, biotech, devices)
- Study start
- 8 Jun 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of HS-20093 as a monotherapy in patients with relapsed or refractory osteosarcoma and other sarcomas.
Detailed description
This is a phase 2, open-label, multi-center study consisting of two parts: Phase 2a and 2b.
Phase 2a: The study will be conducted in the following two cohorts: Cohort 1: Patients with advanced osteosarcoma upon disease progression after standard treatment. Cohort 2: Patients with other unresectable bone and soft tissue sarcomas, if they have progressed on or intolerant to available standard therapies, or no standard or available curative therapy exists. Subjects will be randomly assigned in a 1:1 ratio to 8.0 mg/kg and 12.0 mg/kg of HS-20093 in cohort 1 and will receive 12.0 mg/kg in cohort 2.
Phase 2b: The study will be conducted in patients with advanced osteosarcoma upon disease progression after standard treatment. Subjects will receive HS-20093 at the recommended dose from Phase 2a.
All patients will be carefully followed for adverse events during the study treatment and for 90 days after the last dose of HS-20093. Subjects will be permitted to continue therapy with assessments for progression if the product is well tolerated and sustained clinical benefit exists.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| cohort 1 at HS-20093 8mg/kg (Phase 2a) | Experimental | Drug: HS-20093Participants in cohort 1 will be randomized to receive HS-20093 at 8 mg/kg. |
| cohort 1 at HS-20093 12mg/kg (Phase 2a) | Experimental | Drug: HS-20093Participants in cohort 1 will be randomized to receive HS-20093 at 12 mg/kg. |
| cohort 2 at HS-20093 12mg/kg (Phase 2a) | Experimental | Drug: HS-20093Participants in cohort 2 will receive HS-20093 at 12 mg/kg. |
| HS-20093(Phase 2b) | Experimental | Drug: HS-20093Participants will receive HS-20093 at the recommended dose from Phase 2a. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- At least age of 18 years at screening;
- Patients with histologically confirmed relapsed or refractory osteosarcoma or other sarcomas who have progressed upon first-line systemic treatment.
- At least one measurable lesion according to RECIST 1.1.
- Agree to provide fresh or archival tumor tissue and peripheral blood samples.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
Key exclusion criteria (31 listed)
- Treatment with any of the following:
- Any unresolved toxicities from prior therapy greater than Grade 2 according to Common Terminology Criteria for Adverse Events (CTCAE) 5.0 with the exception of alopecia or neurotoxicity.
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS-20093IV administration of HS-20093 Q3W; Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and confirmed disease progression. | Drug | HS-20093(Phase 2b), cohort 1 at HS-20093 12mg/kg (Phase 2a), cohort 1 at HS-20093 8mg/kg (Phase 2a), cohort 2 at HS-20093 12mg/kg (Phase 2a) |
Primary outcome
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)].
12 secondary outcomes
Incidence and severity of adverse events (AEs)
Time frame: From the first dose through 90 days post end of treatment.
Observed maximum plasma concentration (Cmax) of HS-20093
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Terminal half-life (T1/2) of HS-20093 following the first dose
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093
Time frame: From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
Percentage of participants with antibodies to HS-20093 in serum
Time frame: From pre-dose to 90 days post end of treatment
ORR determined by Independent review committee (IRC) according to RECIST 1.1
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Duration of response (DoR) determined by investigators and IRC according to RECIST 1.1
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Disease control rate (DCR) determined by investigators and IRC according to RECIST 1.1.
Time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
Progression-free survival (PFS) determined by investigators and IRC according to RECIST 1.1
Time frame: From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.
4-month PFS rate determined by investigators and IRC according to RECIST 1.1
Time frame: 4 months.
Overall survival (OS)
Time frame: From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Guo, MD principal investigator
Peking University People's Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HS-20093 in people with Osteosarcoma and Sarcoma, run by Hansoh BioMedical R&D Company at 11 sites in China.
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 9 inclusion and 31 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: looking for participants now, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Wei Guo, MD (010-88326656, bonetumor@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (time frame: From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2024.