JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
NCT ID: NCT05174585
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
21 participants
INTERVENTIONAL
2022-08-18
2025-05-09
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation
Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D.
JAB-BX102 (anti-CD73 monoclonal antibody)
Administered by intravenous infusion (IV)
Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion
JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.
JAB-BX102 (anti-CD73 monoclonal antibody)
Administered by intravenous infusion (IV)
pembrolizumab (anti-PD-1 monoclonal antibody)
Administered by intravenous infusion (IV)
Interventions
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JAB-BX102 (anti-CD73 monoclonal antibody)
Administered by intravenous infusion (IV)
pembrolizumab (anti-PD-1 monoclonal antibody)
Administered by intravenous infusion (IV)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Jacobio Pharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
Countries
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Other Identifiers
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MK-3475-E58
Identifier Type: OTHER
Identifier Source: secondary_id
KEYNOTE-E58
Identifier Type: OTHER
Identifier Source: secondary_id
JAB-BX102-1001
Identifier Type: -
Identifier Source: org_study_id
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