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.
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
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Administered by intravenous infusion (IV)
Administered by intravenous infusion (IV)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
Peking University Third Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Up to 3 years
Dose Escalation phase: Overall response rate (ORR)
The percentage of participants with complete response (CR) or partial response (PR) on RECIST v 1.1.
Time frame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
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Hunan Cancer Hospital
Changsha, Hunan, China
Huashan Hospital
Shanghai, Shanghai Municipality, China
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.
Time frame: 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.
Time frame: 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
Time frame: Up to 3 years