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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174585
• Other study ID #: JAB-BX102-1001
• Secondary ID: MK-3475-E58KEYNO
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 18, 2022
• Est. completion date: March 2026

Study information

• Verified date: March 2024
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: (781) 918-6670
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 62
• Est. completion date: March 2026
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Biological:
• JAB-BX102 (anti-CD73 monoclonal antibody)
Administered by intravenous infusion (IV)
• pembrolizumab (anti-PD-1 monoclonal antibody)
Administered by intravenous infusion (IV)

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Peking University Third Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Hunan Cancer Hospital	Changsha	Hunan
China	Huashan Hospital	Shanghai	Shanghai
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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