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

Last updated: January 5, 2026
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
Overall Status: Completed

Phase

1/2

Condition

Neuroblastoma

Neoplasms

Treatment

JAB-BX102 (anti-CD73 monoclonal antibody)

pembrolizumab (anti-PD-1 monoclonal antibody)

Clinical Study ID

NCT05174585
JAB-BX102-1001
MK-3475-E58
KEYNOTE-E58
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Must be able to provide an archived tumor sample

  • Must have histologically or cytologically confirmed metastatic or locally advancedsolid tumor

  • Must be refractory to or become intolerant of existing therapy(ies) known to provideclinical 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

Exclusion Criteria:

  • Has central nervous system(CNS) metastases or carcinomatous meningitis, except ifCNS metastases treated and no evidence of radiographic progression or hemorrhage forat 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) ormultigated acquisition scan (MUGA)

  • QTcF(Corrected QT interval - Fredericia formula) interval >470 msec

  • Experiencing unresolved CTCAE 5.0 Grade >1 toxicities

Study Design

Total Participants: 21
Treatment Group(s): 2
Primary Treatment: JAB-BX102 (anti-CD73 monoclonal antibody)
Phase: 1/2
Study Start date:
August 18, 2022
Estimated Completion Date:
May 09, 2025

Study Description

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.

Connect with a study center

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui 233004
    China

    Site Not Available

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu 1816440, Anhui 1818058 233004
    China

    Site Not Available

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing 1816670, Beijing Municipality 2038349 100021
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing 1816670, Beijing Municipality 2038349 100191
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou 1784658, Henan 1808520 450052
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha 1815577, Hunan 1806691 410013
    China

    Site Not Available

  • Huashan Hospital

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • Huashan Hospital

    Shanghai 1796236, Shanghai Municipality 1796231 200040
    China

    Site Not Available

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