Clinical trial

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

Name

JAB-BX102-1001

Description

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.

Trial arms

Trial start

2022-08-18

Estimated PCD

2024-03-01

Trial end

2026-03-01

Status

Recruiting

Phase

Early phase I

Treatment

JAB-BX102 (anti-CD73 monoclonal antibody)

Administered by intravenous infusion (IV)

Arms:

Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation, Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion

pembrolizumab (anti-PD-1 monoclonal antibody)

Administered by intravenous infusion (IV)

Arms:

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

Other names:

KEYTRUDA®

Size

Primary endpoint

Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)

First 21 days of Cycle 1

Dose Escalation and Dose Expansion phase: Number of participants with adverse events

Up to 3 years

Dose Expansion phase: Overall response rate (ORR)

Up to 3 years - from baseline to RECIST confirmed Progressive Disease

Expansion phase: Duration of response (DOR)

Up to 3 years

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 62, 'type': 'ESTIMATED'}}

Updated at

2024-03-22

1 organization

2 products

1 indication

Organization

Jacobio Pharmaceuticals

Product

JAB-BX102

Indication

Solid Tumor

Product

Pembrolizumab