JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors

NCT ID: NCT05174585

Last Updated: 2026-01-06

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-18

Study Completion Date

2025-05-09

Brief Summary

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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.

Detailed Description

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The primary objective of this study is to evaluate the safety and tolerability of JAB-BX102 monotherapy to determine the MTD(maximum tolerated dose) and RP2D(Recommended Phase 2 Dose) during Dose Escalation phase; then to evaluate preliminary antitumor activity when JAB-BX102 is administered in combination with pembrolizumab during Dose Expansion phase in patients with advanced solid tumors.

Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

JAB-BX102 (anti-CD73 monoclonal antibody)

Intervention Type BIOLOGICAL

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.

Group Type EXPERIMENTAL

JAB-BX102 (anti-CD73 monoclonal antibody)

Intervention Type BIOLOGICAL

Administered by intravenous infusion (IV)

pembrolizumab (anti-PD-1 monoclonal antibody)

Intervention Type BIOLOGICAL

Administered by intravenous infusion (IV)

Interventions

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JAB-BX102 (anti-CD73 monoclonal antibody)

Administered by intravenous infusion (IV)

Intervention Type BIOLOGICAL

pembrolizumab (anti-PD-1 monoclonal antibody)

Administered by intravenous infusion (IV)

Intervention Type BIOLOGICAL

Other Intervention Names

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KEYTRUDA®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Jacobio Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The First Affiliated Hospital of Bengbu Medical College

Bengbu, Anhui, China

Site Status

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status

Peking University Third Hospital

Beijing, Beijing Municipality, China

Site Status

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Site Status

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status

Huashan Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

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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