ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
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
1 other identifier
interventional
170
1 country
11
Brief 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 relapsed or refractory osteosarcoma and other sarcomas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2023
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 3, 2023
CompletedFirst Posted
Study publicly available on registry
April 26, 2023
CompletedStudy Start
First participant enrolled
June 8, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedAugust 23, 2024
August 1, 2024
2.6 years
April 3, 2023
August 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\].
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)
From the first dose through 90 days post end of treatment.
Observed maximum plasma concentration (Cmax) of HS-20093
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
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
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
From pre-dose to 14 days after the first dose on Cycle 1 (each cycle is 21 days)
- +7 more secondary outcomes
Study Arms (4)
cohort 1 at HS-20093 8mg/kg (Phase 2a)
EXPERIMENTALParticipants in cohort 1 will be randomized to receive HS-20093 at 8 mg/kg.
cohort 1 at HS-20093 12mg/kg (Phase 2a)
EXPERIMENTALParticipants in cohort 1 will be randomized to receive HS-20093 at 12 mg/kg.
cohort 2 at HS-20093 12mg/kg (Phase 2a)
EXPERIMENTALParticipants in cohort 2 will receive HS-20093 at 12 mg/kg.
HS-20093(Phase 2b)
EXPERIMENTALParticipants will receive HS-20093 at the recommended dose from Phase 2a.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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.
- 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.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Peking University People's Hospital
Beijing, China
Hunan Cancer Hospital
Changsha, China
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China
Sun Yat-sen University Cancer Center
Guangzhou, China
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, China
Zhejiang Cancer Hospital
Hangzhou, China
Chinese PLA General Hospital of Eastern Theater Command
Nanjing, China
Shanghai 6th People's Hospital
Shanghai, China
Shanghai General Hospital
Shanghai, China
Tianjin Cancer Hospital
Tianjin, China
Henan Cancer Hospital
Zhengzhou, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wei Guo, MD
Peking University People's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 3, 2023
First Posted
April 26, 2023
Study Start
June 8, 2023
Primary Completion
December 31, 2025
Study Completion (Estimated)
December 31, 2027
Last Updated
August 23, 2024
Record last verified: 2024-08