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

  • End date
    Mar 19, 2026
  • participants needed
  • sponsor
    Jacobio Pharmaceuticals Co., Ltd.
Updated on 19 October 2022


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.


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.

Condition Solid Tumor
Treatment JAB-BX102 (anti-CD73 monoclonal antibody), pembrolizumab (anti-PD-1 monoclonal antibody)
Clinical Study IdentifierNCT05174585
SponsorJacobio Pharmaceuticals Co., Ltd.
Last Modified on19 October 2022


Yes No Not Sure

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
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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