Trial Title:
ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors
NCT ID:
NCT06001255
Condition:
Metastasis Castration Resistant Prostate Cancer(mCRPC)
Conditions: Official terms:
Prostatic Neoplasms
Neoplasm Metastasis
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HS-20093
Description:
Intravenous (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
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. The objectives of this study
are to investigate the anti-tumor activity, safety and pharmacokinetics of HS-20093 in
Chinese patients with metastasis Castration Resistant Prostate Cancer.
This is a phase 2, open-label, multi-center study to evaluate the efficacy, safety,
tolerability and pharmacokinetic (PK) of HS-20093 as a monotherapy in subjects with
metastasis castration resistant prostate cancers (mCRPC) and other solid tumors.
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 metastasis castration resistant prostate cancers who have progressed on or
intolerant to standard therapies. Cohort 2: Other patients with advanced solid tumor if
they have progressed on or intolerant to available standard therapies, or no standard or
available curative therapy exists. All subjects will receive 8 mg/kg of HS-20093.
Phase 2b: The study will be conducted in patients with metastasis castration resistant
prostate cancers who have progressed on or intolerant to standard therapies. Subjects
will receive 8 mg/kg of HS-20093.
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:
- Subjects eligible for inclusion in this study must meet all of the following
criteria:
1. Men or women greater than or equal to 18 years.
2. Locally advanced or metastatic solid tumors confirmed by histology or cytology,
for which standard treatment is invalid, unavailable or intolerable.
3. At least one measurable lesion in accordance with RECIST 1.1.
4. Agree to provide fresh archival tumor tissue.
5. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1.
6. Estimated life expectancy ≥ 12 weeks.
7. Men or women should be using adequate contraceptive measures throughout the
study.
8. Female subjects must not be pregnant at screening or have evidence of
non-childbearing potential.
9. Signed and dated Informed Consent Form.
Exclusion Criteria:
- Any of the following would exclude the subject from participation in the study:
1. 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 prior to the first scheduled dose of HS-20093.
Spinal cord compression or brain metastases. Treatment with drugs that are
predominantly strong inhibitors or inducers or sensitive substrates of CYP3A4,
CYP2D6, P-gp or BCRP 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
2. Patients with BRCA and ATM mutation.
3. 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
4. History of other primary malignancies.
5. Inadequate bone marrow reserve or organ dysfunction.
6. Evidence of cardiovascular risk.
7. Severe, uncontrolled or active cardiovascular diseases.
8. Severe or uncontrolled diabetes, including 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.
9. Severe or poorly controlled hypertension.
10. Bleeding symptoms with apparent clinical significance or obvious bleeding
tendency within 1 months prior to the first dose of HS-20093
11. Serious arteriovenous thrombosis events occurred within 3 months before the
first dose
12. Severe infections occurred within 4 weeks before the first dose
13. 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
14. The presence of active infectious diseases before the first dose such as
hepatitis B, hepatitis C, tuberculosis, syphilis, or human immunodeficiency
virus HIV infection, etc.
15. Hepatic encephalopathy, hepatorenal syndrome, or Child-Pugh Grade B or more
severe cirrhosis
16. Other moderate or severe urinary diseases that may interfere with the detection
or treatment of drug-related urinary toxicity or may seriously affect urinary
function.
17. History of serious neuropathy or mental disorders.
18. Women who are breastfeeding or pregnant or planned to be pregnant during the
study period.
19. Vaccination or hypersensitivity of any level within 4 weeks prior to the first
dose of HS-20093
20. History of severe hypersensitivity reaction, severe infusion reaction or
allergy to recombinant human or mouse derived proteins
21. Hypersensitivity to any ingredient of HS-20093
22. Unlikely to comply with study procedures, restrictions, and requirements in the
opinion of the investigator.
23. 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 Cancer Hospital
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
Xiangya Hospital Central South University
Address:
City:
Changsha
Country:
China
Status:
Recruiting
Facility:
Name:
West China hospital, sichuan university
Address:
City:
Chengdu
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliate Hospital of GUANGZHOU Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Facility:
Name:
Yunnan Cancer Hospital
Address:
City:
Kunming
Country:
China
Status:
Recruiting
Facility:
Name:
Affiliated Drum Tower Hospital, Medical School of Nanjing University
Address:
City:
Nanjing
Country:
China
Status:
Recruiting
Facility:
Name:
Guangxi Medical University Cancer Hospital
Address:
City:
Nanning
Country:
China
Status:
Recruiting
Facility:
Name:
Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Contact:
Last name:
Dingwei Ye, PhD
Phone:
13701663571
Email:
fuscc2012@163.com
Facility:
Name:
Liaoning Tumor Hospital
Address:
City:
Shengyang
Country:
China
Status:
Recruiting
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shengyang
Country:
China
Status:
Recruiting
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shengyang
Country:
China
Status:
Recruiting
Facility:
Name:
Hubei Cancer Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
Tongji Hospital
Address:
City:
Wuhan
Country:
China
Status:
Recruiting
Facility:
Name:
The First Affiliated Hospital of Zhengzhou University
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Start date:
January 18, 2024
Completion date:
December 31, 2025
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/NCT06001255
