Clinical trial · Interventional
A Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181
A Phase Ib Clinical Study Evaluating the Preliminary Anti-tumor Efficacy and Safety of Hemay181 in Patients With Advanced Solid Tumours
NCT07446816CI-TRIAL-00104444recruitingPhase 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)
An open-label phase I clinical study,which enrolled subjects with advanced solid tumors who have failed to respond to adequate standard therapies or have no available effective standard therapy.
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 |
|---|---|---|---|
| Hemay181 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- Intravenous infusion, Once per treatment cycle
- interventionNames
- Drug: Hemay181
Primary outcomes (1)
- measure
- Efficacy indicators
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
- description
- Objective response rate (ORR)
Secondary outcomes (1)
- measure
- Safety indicators
- timeFrame
- From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Subjects who voluntarily signed a written informed consent form before the start of the study; 2. Subjects who have pathologically (histologically or cytologically) confirmed advanced solid tumorsand have failed to respond to adequate standard therapies or currently have no available effective standard therapy . 3. Subjects who have a least one measurable lesion that can be evaluated by CT/MRI and meets the requirement for reproducible evaluation in RECIST V1.1; 4. At least 4 weeks or 5 half-lives (whichever is longer) following the most recent treatment (chemotherapy, targeted therapy, immunotherapy, radiotherapy, and/or major surgery), with recovery from treatment-induced adverse reactions to ≤ Grade 1 (CTCAE Version 5.0) \[Patients with alopecia (any grade), hyperpigmentation (any grade), or peripheral sensory neuropathy (≤ Grade 2) may be included\]. 5. Subjects with ECOG PS score of 0-1; 6. Subjects with expected survival more than 3 months; 7. Women of childbearing potential (including partners) who are not planning to become pregnant and who voluntarily take effective contraceptive measures from signing the informed consent form until 6 months after the last dose in the study; Exclusion Criteria: 1. Women during pregnancy or breastfeeding; 2. HIV test positive; syphilis test positive; hepatitis B surface antigen positive with HBV-DNA exceeding the upper limit of normal; hepatitis C virus (HCV) antibody positive with HCV-RNA exceeding the upper limit of normal; 3. Having received drug treatment from another clinical trial within the four weeks prior to enrolment; 4. Aallergy to the active ingredient or excipients of the investigational medicinal product; 5. Patients with a history of alcohol or drug abuse or dependence, or a history of severe mental illness; 6. The investigator considers the subject to be unsuitable for participation in this clinical trial due to any clinical or laboratory abnormalities.
References
Publications (0)
Data not yet available
No reference posted for this study.