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

Phase 1

Recruiting

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

Brief 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.

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.

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion	JAB-BX102 (anti-CD73 monoclonal antibody)	JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.
Arm B, JAB-BX102 combination with pembrolizumab, Phase 2a, Dose Expansion	pembrolizumab (anti-PD-1 monoclonal antibody)	JAB-BX102 will be administered in combination with pembrolizumab in specific solid tumor patients to evaluate the preliminary antitumor activity.
Arm A, JAB-BX102 monotherapy, Phase 1, Dose Escalation	JAB-BX102 (anti-CD73 monoclonal antibody)	Dose escalation of JAB-BX102 will be administered as monotherapy to determine the MTD and RP2D.

Primary Outcome Measures

Name	Time	Method
Dose Escalation and Dose Expansion phase: Number of participants with adverse events	Up to 3 years	Patients will be assessed for incidence and severity of adverse events (AEs) according to NCI-CTCAE 5.0.
Expansion phase: Duration of response (DOR)	Up to 3 years	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.
Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)	First 21 days of Cycle 1	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.
Dose Expansion phase: Overall response rate (ORR)	Up to 3 years - from baseline to RECIST confirmed Progressive Disease	ORR is defined as the percentage of participants with complete response (CR) or partial response (PR) per RECIST v 1.1.

Secondary Outcome Measures

Name	Time	Method
To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab	Up to 3 years	observed plasma concentration of JAB-BX102
Dose Escalation phase: Overall response rate (ORR)	Up to 3 years - from baseline to RECIST confirmed Progressive Disease	The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
Dose Escalation phase: Duration of response (DOR)	Up to 3 years	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.
Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)	Up to 3 years	DCR is defined as percentage of participants with complete response (CR), partial response (PR), or stable disease (SD) per CTCAE v1.1.
Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)	Up to 3 years	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

Locations (6): The First Affiliated Hospital of Bengbu Medical College
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Bengbu, Anhui, China
The First Affiliated Hospital of Zhengzhou University
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Zhengzhou, Henan, China
Hunan Cancer Hospital
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Changsha, Hunan, China
Peking University Third Hospital
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Beijing, Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences
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Beijing, Beijing, China
Huashan Hospital
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Shanghai, Shanghai, China