Actively Recruiting
HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Led by Hansoh BioMedical R&D Company · Updated on 2026-03-10
40
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
HS-20093 is a humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. This is a phase 1b, open-label, multi-center study to evaluate the efficacy, safety, tolerability, and pharmacokinetics of HS-20093 in patients with advanced gastric and gastroesophageal junction adenocarcinoma.
CONDITIONS
Official Title
HS-20093 in Patients With Advanced Gastric and Gastroesophageal Junction Adenocarcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least age of 18 years at screening, with no restrictions on gender.
- Signed and dated Informed Consent Form.
- Participants with pathologically or cytologically confirmed locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed or are intolerant to standard therapies.
- At least one extra measurable lesion according to RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Estimated life expectancy greater than 12 weeks.
- Agree to provide fresh or archival tumor tissue.
- Good organ function.
- Female subjects must not be pregnant at screening or have evidence of non-childbearing potential.
- Men or women should be using adequate contraceptive measures throughout the study.
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy.
- Previous or current treatment with topoisomerase I inhibitors.
- Any cytotoxic chemotherapy, investigational agents, or anticancer drugs within 14 days prior to first scheduled dose of HS-20093.
- Prior treatment with a monoclonal antibody within 28 days prior to first scheduled dose.
- Local radiotherapy for palliation within 2 weeks of first dose, or more than 30% bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to first dose.
- Treatment with drugs that are strong CYP3A4 inhibitors, inducers, or sensitive substrates within 7 days prior to first dose or requiring these drugs during study.
- Currently receiving drugs known to prolong QT interval or cause torsade de pointe or requiring these drugs during study.
- Histology showing squamous cell carcinoma, undifferentiated carcinoma, or mixed tumors such as adenosquamous carcinoma.
- Any unresolved toxicities from prior therapy greater than Grade 1.
- Presence of pleural effusion or ascites requiring clinical intervention.
- Untreated or unstable brain metastases, leptomeningeal metastasis, brainstem metastasis, or spinal cord compression.
- History of other primary malignancies.
- Evidence of cardiovascular risk or severe uncontrolled cardiovascular diseases.
- Severe or poorly controlled hypertension or diabetes.
- Poorly controlled cancer-related pain.
- Active infectious diseases including hepatitis B, hepatitis C, or HIV.
- Major surgery within 4 weeks prior to first dose.
- Active infection requiring intravenous antibiotics within 2 weeks prior to first dose.
- Significant bleeding symptoms or hemorrhagic tendency within 1 month prior to first dose.
- Recent serious arterial or venous thromboembolic events within 3 months prior to first dose.
- Active tuberculosis.
- History of interstitial pneumonia or immune-mediated pneumonitis.
- History of autoimmune disease requiring systemic treatment.
- Severe malnutrition.
- Current hepatic encephalopathy, hepatorenal syndrome, or cirrhosis Child-Pugh class B or worse.
- Requires long-term glucocorticoid therapy.
- Vaccination within 4 weeks prior to first dose.
- History of severe allergy.
- Serious neurological or mental disorders affecting compliance.
- Currently enrolled in other clinical studies involving investigational treatments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here