JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
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 Design
Arms and Interventions
| 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)
|
Outcome Measures
Primary Outcome Measures
- 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.
- 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.
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
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
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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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Jacobio Pharmaceuticals Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- JAB-BX102-1001