Clinical trial · Interventional
JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
NCT05174585CI-TRIAL-00100182completedPhase 1 / Phase 2ClinicalTrials.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 study is to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with 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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| JAB-BX102 (anti-CD73 monoclonal antibody) | Biological | — | UNRESOLVED |
| pembrolizumab (anti-PD-1 monoclonal antibody) | Biological | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation
- description
- Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D.
- interventionNames
- Biological: JAB-BX102 (anti-CD73 monoclonal antibody)
- type
- EXPERIMENTAL
- label
- Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion
- description
- JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.
- interventionNames
- Biological: JAB-BX102 (anti-CD73 monoclonal antibody)
- Biological: pembrolizumab (anti-PD-1 monoclonal antibody)
Primary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be able to provide an archived tumor sample * Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor * Must be refractory to or become intolerant of existing therapy(ies) known to provide clinical benefit for their condition, or patient has no access to SOC treatment. * Must have at least 1 measurable lesion per RECIST v1.1 * Must have adequate organ functions Exclusion Criteria: * Has central nervous system(CNS) metastases or carcinomatous meningitis, except if CNS metastases treated and no evidence of radiographic progression or hemorrhage for at least 28 days * Active infection requiring systemic treatment within 7 days * Active hepatitis C virus(HBV), hepatitis C virus(HCV), or HIV * Any severe and/or uncontrolled medical conditions * Left ventricular ejection fraction(LVEF) ≤50% assessed by echocardiogram (ECHO) or multigated acquisition scan (MUGA) * QTcF(Corrected QT interval - Fredericia formula) interval \>470 msec * Experiencing unresolved CTCAE 5.0 Grade \>1 toxicities
References
Publications (0)
Data not yet available
No reference posted for this study.