Clinical trial · Interventional
A First-in-Human Study of JAB-8263 in Adult Patients With Advanced Solid Tumors
A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-8263 in Adult Subjects With Advanced Solid Tumors
NCT04587479CI-TRIAL-00100698completedPhase 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 Phase 1, first-in-human, open-label study of JAB-8263 to determine the maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and assess the DLT. 30 subjects with advanced solid tumor will be enrolled.
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 Tumors, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JAB-8263 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- JAB-8263
- description
- Monotherapy, dose escalation
- interventionNames
- Drug: JAB-8263
Primary outcomes (2)
- measure
- Number of participants with dose limiting toxicities
- timeFrame
- Approximately 2.5 years
- description
- Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with JAB-8263
- measure
- Find Recommended Phase 2 Dose (RP2D) of JAB-8263
- timeFrame
- Approximately 2.5 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Subjects must meet all the following criteria in order to be included in the research study: 1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy(ies), or are intolerant to standard therapy(ies), or have a tumor for which no standard therapy(ies) exists. 4. Subjects with life expectancy ≥3 months. 5. Patients must have at least one measurable lesion as defined by RECIST v1.1. 6. Patients who have sufficient baseline organ function. Exclusion Criteria: 1. History (≤3 years) of cancer that is histologically distinct from the cancer under study. 2. Known serious allergy to investigational drug or excipients 3. Active brain or spinal metastases 4. History of pericarditis or Grade ≥2 pericardial effusion 5. History of interstitial lung disease. 6. History of Grade ≥2 active infections within 2 weeks 7. Known human immunodeficiency virus (HIV) infection 8. Seropositive for hepatitis B virus (HBV) 9. Seropositive for hepatitis C virus (HCV), or HCV-RNA viral levels are not detectable. 10. Any severe and/or uncontrolled medical conditions 11. History of myocardial infarction, unstable angina pectoris, coronary artery bypass graft, or cerebrovascular accident 12. Impaired cardiac function or clinically significant cardiac diseases 13. QTcF \>470 msec at screening 14. History of medically significant thromboembolic events or bleeding diathesis 15. Unresolved Grade \>1 toxicity 16. History of malignant biliary obstruction 17. Pregnant or breast-feeding
References
Publications (0)
Data not yet available
No reference posted for this study.