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

  • STATUS
    Recruiting
  • End date
    Mar 19, 2026
  • participants needed
    62
  • sponsor
    Jacobio Pharmaceuticals Co., Ltd.
Updated on 19 October 2022

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.

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.

Details
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

Eligibility

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

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

Learn more

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.

Learn more

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

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note