Status:
RECRUITING
ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors
Lead Sponsor:
Hansoh BioMedical R&D Company
Conditions:
Metastasis Castration Resistant Prostate Cancer(mCRPC)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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. The objectives of this study are to investigate 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 metastasis cast...
Eligibility Criteria
Inclusion
- Subjects eligible for inclusion in this study must meet all of the following criteria:
- Men or women greater than or equal to 18 years.
- Locally advanced or metastatic solid tumors confirmed by histology or cytology, for which standard treatment is invalid, unavailable or intolerable.
- At least one measurable lesion in accordance with RECIST 1.1.
- Agree to provide fresh archival tumor tissue.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1.
- Estimated life expectancy ≥ 12 weeks.
- Men or women should be using adequate contraceptive measures throughout the study.
- Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.
- Signed and dated Informed Consent Form.
Exclusion
- Any of the following would exclude the subject from participation in the study:
- 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
- Patients with BRCA and ATM mutation.
- 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.
- 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.
- 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 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 urinary diseases that may interfere with the detection or treatment of drug-related urinary toxicity or may seriously affect urinary function.
- History of serious neuropathy or mental disorders.
- 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.
Key Trial Info
Start Date :
January 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06001255
Start Date
January 18 2024
End Date
December 31 2025
Last Update
August 20 2024
Active Locations (15)
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1
Peking University Cancer Hospital
Beijing, China
2
Hunan Cancer Hospital
Changsha, China
3
Xiangya Hospital Central South University
Changsha, China
4
West China hospital, sichuan university
Chengdu, China