Clinical trial · Interventional
A Study of HS-20124 in Patients with Advanced Solid Tumors
A Phase I, Open-label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of HS-20124 in Patients with Advanced Solid Tumors
NCT06763159CI-TRIAL-00084457recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Cancer | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-20124 (Phase Ia：Dose escalation ) | Drug | — | UNRESOLVED |
| HS-20124 (Phase Ib: Dose expansion) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- HS-20124 (Phase Ia：Dose escalation )
- description
- HS-20124 for IV infusion of various dose strengths administered in 21 day dosing cycles
- interventionNames
- Drug: HS-20124 (Phase Ia：Dose escalation )
- type
- EXPERIMENTAL
- label
- HS-20124 (Phase Ib: Dose expansion)
- description
- The recommended dose from the dose-escalation stage and other potential doses will be further explored
- interventionNames
- Drug: HS-20124 (Phase Ib: Dose expansion)
Primary outcomes (2)
- measure
- Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). ORR is evaluated by the number of participants with best overall response of complete response (CR) an
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.