Clinical trial · Interventional
A Phase 1 Study to Evaluate JS019 in Advanced Solid Tumors or Lymphomas
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 or Lymphomas
- 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/lymphomas. The study includes JS019 monotherapy dose escalation, dose expansion and indication 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 or Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JS019 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- JS019 0.3 mg/kg
- description
- repeat dose every 21 days up
- interventionNames
- Biological: JS019
- type
- EXPERIMENTAL
- label
- JS019 1 mg/kg
- description
- repeat dose every 21 days up
- interventionNames
- Biological: JS019
- type
- EXPERIMENTAL
- label
- JS019 3 mg/kg
- description
- repeat dose every 21 days up
- interventionNames
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 or lymphomas; 4. Failed or unsuitable for standard treatment, received at least one line of systemic 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 or Lugano 2014; 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.); 6. Patients who have discontinued immunotherapy due to immune-related AEs. 7. Patients who have used immunosuppressive drugs within 4 weeks prior to the first dose of JS019, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids ≤10 mg/day prednisone or equivalent.
References
Publications (0)
Data not yet available