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New treatment option for Advanced Solid Tumor
Official title ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06332170
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 advanced solid tumor.
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 safety, tolerability, pharmacokinetics and anti-tumor activity of HS-20093 in combination with other anti-cancer agents in patients with advanced solid tumor patients.
- Phase 1: an early, usually small safety study
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
- At least age of 18 years at screening;
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumors
- Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable.
- Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
- least one extra-cranial measurable lesion according to RECIST 1
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...
- people with previous or concurrent malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Evidence of current severe or uncontrolled systemic diseases
- Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
See the full eligibility criteria
- At least age of 18 years at screening;
- Histologically or cytologically confirmed, locally advanced or metastatic solid tumors
- Dose escalation part will enroll advanced solid tumor for which standard treatment has proven ineffective or unavailable or intolerable.
- Dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.
- least one extra-cranial measurable lesion according to RECIST 1
- Agree to provide fresh or archival tumor tissue
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1
- Life expectancy \>= 12 weeks
- Agree to use medically accepted methods of contraception
- Men or women should be using adequate contraceptive measures throughout the study;
- Females 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 Intolerable for any PD-L1 inhibitor...
- people with previous or concurrent malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Evidence of current severe or uncontrolled systemic diseases
- Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20093
- Known active infection requiring antibodies treatment within 2 weeks, or severe infection within 4 weeks prior to the first scheduled dose of HS-20093
- people with current infectious diseases
- History of neuropathy or mental disorders
- Pregnant or lactating female
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20093 or any of the components 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
- Shanghai, Shanghai Municipality, 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 Shanghai, Shanghai Municipality, China. 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.