NCT06763159 A Study of HS-20124 in Patients with Advanced Solid Tumors
| NCT ID | NCT06763159 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Hansoh BioMedical R&D Company |
| Condition | Solid Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 450 participants |
| Start Date | 2024-10-30 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 450 participants in total. It began in 2024-10-30 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
HS-20124 is a novel DAR-8 antibody-drug conjugate （ADC） targeting CDH6. In preclinical studies, it inhibited tumor cell growth expressing CDH6 in vitro and in vivo. The first-in-human trial is conducted to assess the maximum tolerated dose (MTD) and dose limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary anti-tumor activity of HS-20124 in Patients With Advanced Solid Tumors.
Eligibility Criteria
Inclusion Criteria: 1. At least age of 18 years at screening; 2. Histologically or cytologically confirmed, locally advanced or metastatic solid tumors for which standard treatment either does not exist or has proven ineffective or unavailable or intolerable 3. At least one extra-cranial measurable lesion according to RECIST 1 4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0\~1 5. Life expectancy \>= 12 weeks 6. Men or women should be using adequate contraceptive measures throughout the study; 7. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential 8. Signed and dated Informed Consent Form Exclusion Criteria: 1.Treatment with any of the following: 1. Previous or current treatment with CDH6 targeted therapy 2. Any cytotoxic chemotherapy and small molecule targeted anticancer drugs within 21 days or five half-livesprior to the first scheduled dose of HS-20124 3. Prior treatment with a monoclonal antibody or investigational agents within 28 days prior to the first scheduled dose of HS-20124 4. 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-20124 5. Major surgery within 4 weeks prior to the first scheduled dose of HS-20124 2. Subjects with previous or concurrent malignancies 3. Inadequate bone marrow reserve or organ dysfunction 4. Evidence of cardiovascular risk 5. Evidence of current severe or uncontrolled systemic diseases 6. Evidence of mucosal or internal bleeding within 1 month prior to the first scheduled dose of HS-20124 7. Severe infection within 4 weeks prior to the first scheduled dose of HS-20124 8. Subjects with current infectious diseases 9. History of neuropathy or mental disorders 10. Pregnant or lactating female 11. History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to HS-20124 or any of the components of HS-20124
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06763159 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06763159 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06763159 currently recruiting?
Yes, NCT06763159 is actively recruiting participants. Contact the research team at JJYIN555@163.com for enrollment information.
Where is the NCT06763159 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06763159 clinical trial?
NCT06763159 is sponsored by Hansoh BioMedical R&D Company. The trial plans to enroll 450 participants.
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