JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult 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 to evaluate the safety and tolerability of JAB-BX102 monotherapy and combination therapy with pembrolizumab in adult participants with advanced solid tumors.

Study Overview

• Status: Recruiting
• Conditions: Solid Tumor
• Intervention / Treatment: Biological: JAB-BX102 (anti-CD73 monoclonal antibody); Biological: pembrolizumab (anti-PD-1 monoclonal antibody)

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 62
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Jacobio Pharmaceuticals; Phone Number: (781) 918-6670; Email: clinicaltrials@jacobiopharma.com
• Study Contact Backup: Name: Zhiwen He; Email: Zhiwen.he@jacobiopharma.com

Study Locations

• China
  • Anhui
    • Bengbu, Anhui, China, 233004
      • Recruiting
      • The First affiliated hospital of bengbu medical college
  • Beijing
    • Beijing, Beijing, China, 100191
      • Recruiting
      • Peking University Third Hospital
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Not yet recruiting
      • The First Affiliated Hospital of Zhengzhou University
  • Hunan
    • Changsha, Hunan, China, 410013
      • Not yet recruiting
      • Hunan Cancer Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200040
      • Recruiting
      • Huashan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation; Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D.	Biological: JAB-BX102 (anti-CD73 monoclonal antibody); Administered by intravenous infusion (IV)
Experimental: Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion; JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.	Biological: JAB-BX102 (anti-CD73 monoclonal antibody); Administered by intravenous infusion (IV); Biological: pembrolizumab (anti-PD-1 monoclonal antibody); Administered by intravenous infusion (IV); Other Names: KEYTRUDA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)	A DLT is defined as the clinically significant TRAE(treatment-related adverse events) or abnormal laboratory values assessment during the first 21 days of Cycle 1 and excludes events that are deemed clearly related to underlying disease, progression, or intercurrent illness.	First 21 days of Cycle 1
Dose Escalation and Dose Expansion phase: Number of participants with adverse events	Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE 5.0.	Up to 3 years
Dose Expansion phase: Overall response rate (ORR)	ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.	Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Expansion phase: Duration of response (DOR)	DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.	Up to 3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Escalation phase: Overall response rate (ORR)	The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.	Up to 3 years - from baseline to RECIST confirmed Progressive Disease
Dose Escalation phase: Duration of response (DOR)	DOR is defined as the time from the participant's initial objective response (CR or PR) to disease progression per CTCAE v1.1 or death due to any cause, whichever occurs first.	Up to 3 years
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)	DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per CTCAE v1.1.	Up to 3 years
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)	PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression per CTCAE v1.1 or death which occurs first	Up to 3 years
To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab	observed plasma concentration of JAB-BX102	Up to 3 years

Collaborators and Investigators

• Sponsor: Jacobio Pharmaceuticals Co., Ltd.
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): August 18, 2022
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: December 14, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): January 3, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Solid Tumor
• Additional Relevant MeSH Terms: Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Antibodies; Immunoglobulins; Pembrolizumab; Antibodies, Monoclonal; Antineoplastic Agents, Immunological
• Other Study ID Numbers: JAB-BX102-1001; MK-3475-E58 (Other Identifier: Merck Sharp & Dohme LLC); KEYNOTE-E58 (Other Identifier: Merck Sharp & Dohme LLC)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No