Solid Tumor
Conditions
Keywords
Solid Tumor, Anti-CD73 Monoclonal Antibody, CD73
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.
Interventions
BIOLOGICALJAB-BX102 (anti-CD73 monoclonal antibody)
Administered by intravenous infusion (IV)
BIOLOGICALpembrolizumab (anti-PD-1 monoclonal antibody)
Administered by intravenous infusion (IV)
Sponsors
Merck Sharp & Dohme LLC
Jacobio Pharmaceuticals Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
Countries
China
Outcome results
None listed