Trial Title:
ARTEMIS-002: HS-20093 in Patients With Relapsed or Refractory Osteosarcoma and Other Sarcomas
NCT ID:
NCT05830123
Condition:
Osteosarcoma
Sarcoma
Conditions: Official terms:
Sarcoma
Osteosarcoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20093
Description:
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.
Arm group label:
HS-20093(Phase 2b)
Arm group label:
cohort 1 at HS-20093 12mg/kg (Phase 2a)
Arm group label:
cohort 1 at HS-20093 8mg/kg (Phase 2a)
Arm group label:
cohort 2 at HS-20093 12mg/kg (Phase 2a)
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.
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. At least age of 18 years at screening;
2. Patients with histologically confirmed relapsed or refractory osteosarcoma or other
sarcomas who have progressed upon first-line systemic treatment.
3. At least one measurable lesion according to RECIST 1.1.
4. Agree to provide fresh or archival tumor tissue and peripheral blood samples.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
6. Life expectancy >= 12 weeks
7. Men or women should be using adequate contraceptive measures throughout the study;
8. Females subjects must not be pregnant at screening or have evidence of
non-childbearing potential
9. Signed and dated Informed Consent Form
Exclusion Criteria:
1. Treatment with any of the following:
1. Previous or current treatment with B7-H3 targeted therapy
2. Any cytotoxic chemotherapy, investigational agents and anticancer drugs within
14 days prior to the first scheduled dose of HS-20093
3. Prior treatment with a monoclonal antibody within 28 days prior to the first
scheduled dose of HS-20093
4. 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
5. Pleural or peritoneal effusion requiring clinical intervention. Pericardial
effusion.
6. Major surgery within 4 weeks of the first dose of HS-20093.
7. Spinal cord compression or brain metastases.
8. 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.
9. Currently receiving drugs known to prolong QT interval or may cause torsade de
pointe; or requiring treatment with these drugs during the study.
2. 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.
3. History of other primary malignancies.
4. Inadequate bone marrow reserve or organ dysfunction
5. Evidence of cardiovascular risk.
6. Severe, uncontrolled or active cardiovascular diseases.
7. 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.
8. Severe or poorly controlled hypertension.
9. Bleeding symptoms with apparent clinical significance or obvious bleeding tendency
within 1 months prior to the first dose of HS-20093
10. Serious arteriovenous thrombosis events occurred within 3 months before the first
dose.
11. Severe infections occurred within 4 weeks before the first dose.
12. 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
13. 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.
14. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more severe
cirrhosis.
15. 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.
16. Previous history of serious neurological or mental disorders, including epilepsy,
dementia or severe depression and any other status that may interfere in assessment.
17. Women who are breastfeeding or pregnant or planned to be pregnant during the study
period.
18. Vaccination or hypersensitivity of any level within 4 weeks prior to the first dose
of HS-20093
19. History of severe hypersensitivity reaction, severe infusion reaction or allergy to
recombinant human or mouse derived proteins.
20. Hypersensitivity to any ingredient of HS-20093.
21. Unlikely to comply with study procedures, restrictions, and requirements in the
opinion of the investigator
22. Any disease or condition that, in the opinion of the investigator, would compromise
subject safety or interfere with study assessments
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
First Affiliated Hospital, Sun Yat-Sen University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
jin Wang
Facility:
Name:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Zhejiang Cancer Hospital
Address:
City:
Hangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Chinese PLA General Hospital of Eastern Theater Command
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai 6th People's Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Shanghai General Hospital
Address:
City:
Shanghai
Country:
China
Status:
Recruiting
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Country:
China
Status:
Recruiting
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Start date:
June 8, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Hansoh BioMedical R&D Company
Agency class:
Industry
Source:
Hansoh BioMedical R&D Company
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05830123
