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New treatment option for Metastasis Castration Resistant Prostate Cancer(mCRPC)
Official title ARTEMIS-003: HS-20093 in Patients With Metastatic Castrate-resistant Prostate Cancer (mCRPC) and Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06001255
What this study is testing
What is HS-20093?
HS-20093 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastasis castration resistant prostate cancer(mcrpc).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- people 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.
You likely can't join if
- 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...
- 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...
- History of other primary malignancies.
- Inadequate bone marrow reserve or organ dysfunction.
See the full eligibility criteria
- people 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 people must not be pregnant at screening or have evidence of non-childbearing potential.
- Signed and dated Informed Consent Form.
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
- Changsha, China
- Chengdu, China
- Guangzhou, China
- Kunming, China
- Nanjing, China
- Nanning, China
- Shanghai, China
- Shengyang, China
- Wuhan, China
- Zhengzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China; Changsha, China; Chengdu, China; Guangzhou, China; Kunming, China; Nanjing, China and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.