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

Last updated: March 20, 2024
Sponsor: Jacobio Pharmaceuticals Co., Ltd.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Neuroblastoma

Neoplasms

Treatment

pembrolizumab (anti-PD-1 monoclonal antibody)

JAB-BX102 (anti-CD73 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 if CNSmetastases treated and no evidence of radiographic progression or hemorrhage for atleast 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: 62
Treatment Group(s): 2
Primary Treatment: pembrolizumab (anti-PD-1 monoclonal antibody)
Phase: 1/2
Study Start date:
August 18, 2022
Estimated Completion Date:
March 31, 2026

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

    Active - Recruiting

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing 100021
    China

    Active - Recruiting

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan 450052
    China

    Site Not Available

  • Hunan Cancer Hospital

    Changsha, Hunan 410013
    China

    Site Not Available

  • Huashan Hospital

    Shanghai, Shanghai 200040
    China

    Active - Recruiting

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