Clinical trial · Interventional
A Clinical Study to Evaluate the Safety, Tolerability,JS019 in Patients With Advanced Solid Tumors
A Phase 1 Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Recombinant Fully Human Anti-CD39 Monoclonal Antibody JS019 in Patients With Advanced Solid Tumors
- 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 phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of JS019 as monotherapy in patients with advanced malignant solid tumors The study includes JS019 monotherapy dose escalation, dose expansion stages to investigate the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of JS019 as monotherapy.
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 |
|---|---|---|---|
| JS019 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Dose Escalation: dose level:0.3mg/kg
- description
- Dose Escalation: 0.3mg/kg, IV infusion, every 3 weeks (q3w).
- interventionNames
- Biological: JS019
- type
- EXPERIMENTAL
- label
- Dose Escalation: dose level:1 mg/kg
- description
- Dose Escalation: 1 mg/kg IV infusion, every 3 weeks (q3w).
- interventionNames
- Biological: JS019
- type
- EXPERIMENTAL
- label
- Dose Escalation: dose level:3 mg/kg
- description
- Dose Escalation: 3 mg/kg IV infusion, every 3 weeks (q3w).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Be able to understand and willing to sign the Informed Consent Form; 2. Male or female aged 18\~75 years (included); 3. Patients with pathologically confirmed advanced malignant solid tumors 4. Failed or unsuitable for standard treatment; 5. Eastern Cooperative Oncology Group (ECOG) physical fitness score: 0\~1; 6. Expected survival period ≥ 12 weeks; 7. At least one measurable lesion according to criteria RECIST v1.1 ; Exclusion Criteria: 1. Patients with known hypersensitivity to the components of JS019; 2. Patients who have received the treatment with anti-CD39 antibodies or inhibitors; 3. Patients who participated in other clinical studies within 4 weeks prior to the first administration of JS019, except patients are in the follow-up period of observational (non-interventional) clinical study or interventional study; 4. Patients who have received major surgery within 4 weeks before the first dose or expected to undergo major surgery during the study (as judged by the investigator) or are in the recovery period from surgery; 5. Patients who have received anti-tumor therapy, such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or biological therapy, within 4 weeks or 5 half-lives of the therapy (whichever is shorter) prior to the first dose of JS019. Patients who have received traditional Chinese medicine or Chinese patent medicine preparations with anti-tumor indications within 2 weeks before the first dose of JS019. Can accept hormone therapy for non-tumor-related diseases (such as insulin therapy for diabetes and hormone replacement therapy, etc.);
References
Publications (0)
Data not yet available