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

Jacobio Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Biological: JAB-BX102 (anti-CD73 monoclonal antibody); Biological: pembrolizumab (anti-PD-1 monoclonal antibody)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05174585

KEYNOTE-E58 (Other Identifier)

MK-3475-E58 (Other Identifier)

JAB-BX102-1001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation

Experimental group

Description:

Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D.

Treatment:

Biological: JAB-BX102 (anti-CD73 monoclonal antibody)

Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion

Experimental group

Description:

JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.

Treatment:

Biological: pembrolizumab (anti-PD-1 monoclonal antibody)

Biological: JAB-BX102 (anti-CD73 monoclonal antibody)