Clinical trial · Interventional
A Study of HS-20122 in Patients With Advanced Solid Tumors
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HS-20122 in Patients With Advanced Solid Tumors
NCT06927570CI-TRIAL-00101089recruitingPhase 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)
This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in 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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HS-20122 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HS-20122
- description
- All subjects will receive HS-20122 in a continuous regimen in dose escalation stage or dose expansion stage
- interventionNames
- Drug: HS-20122
Primary outcomes (1)
- measure
- The maximum tolerated dose (MTD) or the maximum applicable dose (MAD)
- timeFrame
- From time of first dose of HS-20122 to end of DLT period (approximately 21 days)
- description
- To determine the MTD or MAD for further evaluation of intravenous administration of HS-20122 in subjects with advanced solid tumors
Secondary outcomes (8)
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females, aged ≥ 18 years. * Subjects with histologically or cytologically confirmed locally advanced or metastatic Solid Tumors * Standard treatment is invalid, unavailable or intolerable. * At least 1 target lesion according to RECIST 1.1. * ECOG PS score: 0-1. * Estimated Life expectancy\> 12 weeks. * Men or women should be using adequate contraceptive measures throughout the study. * Women must have the evidence of non-childbearing potential. * Signed and dated Informed Consent Form. Exclusion Criteria: * 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. * Subjects with severe or poorly controlled diabetes. * Subjects with severe or poorly controlled hypertension. * Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * Subjects with severe arteriovenous thrombotic events within 3 months. * Subjects with severe infection within 4 weeks prior to the first dose. * Subjects who have received steroid therapy for more than 30 days . * Presence of known active infectious diseases. * Presence of clinically significant gastrointestinal dysfunction. * Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B. * Moderate to severe pulmonary diseases. * Prior history of significant neurological or mental disorders. * Women who are breastfeeding or pregnant or planned to be pregnant during the study period. * Hypersensitivity to any ingredient of HS-20122. * 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 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. * Subjects with severe or poorly controlled diabetes. * Subjects with severe or poorly controlled hypertension. * Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 1 month prior to the first dose. * Subjects with severe arteriovenous thrombotic events within 3 months. * Subjects with severe infection within 4 weeks prior to the first dose. * Subjects who have received steroid therapy for more than 30 days . * Presence of known active infectious diseases. * Presence of clinically significant gastrointestinal dysfunction. * Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis ≥ Child-Pugh Grade B. * Moderate to severe pulmonary diseases. * Prior history of significant neurological or mental disorders. * Women who are breastfeeding or pregnant or planned to be pregnant during the study period. * Hypersensitivity to any ingredient of HS-20122. * 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
References
Publications (0)
Data not yet available
No reference posted for this study.