Evaluating JAB-BX102 alone and with pembrolizumab in patients with advanced solid tumors

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

This study is testing a new treatment called JAB-BX102, alone and with another drug called pembrolizumab, to see if it is safe and helps people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jacobio Pharmaceuticals Co., Ltd. (industry)
• Drugs / interventions: pembrolizumab
• Locations: 6 sites (Bengbu, Anhui and 5 other locations)
• Trial ID: NCT05174585 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of JAB-BX102, an anti-CD73 monoclonal antibody, both as a standalone treatment and in combination with pembrolizumab, an anti-PD-1 monoclonal antibody, in adult patients with advanced solid tumors. The trial consists of a Dose Escalation phase to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JAB-BX102, followed by a Dose Expansion phase to evaluate the preliminary antitumor activity of the combination therapy. Participants must have confirmed metastatic or locally advanced solid tumors that are refractory to existing therapies.

Who should consider this trial

Good fit: Ideal candidates include adults with advanced solid tumors that are refractory to or intolerant of existing therapies.

Not a fit: Patients with central nervous system metastases, active infections, or severe uncontrolled medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited treatment alternatives.

How similar studies have performed: Other studies have shown promise with similar combination therapies, indicating potential for success in this approach.

Eligibility criteria

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

Where this trial is running

Bengbu, Anhui and 5 other locations

• The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui, China (RECRUITING)
• Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing, China (RECRUITING)
• Peking University Third Hospital — Beijing, Beijing, China (RECRUITING)
• The First Affiliated Hospital of Zhengzhou University — Zhengzhou, Henan, China (NOT_YET_RECRUITING)
• Hunan Cancer Hospital — Changsha, Hunan, China (NOT_YET_RECRUITING)
• Huashan Hospital — Shanghai, Shanghai, China (RECRUITING)

Study contacts

• Study coordinator: Jacobio Pharmaceuticals

Conditions: Solid Tumor