Clinical trial NCT05174585: JAB-BX102 Monotherapy and Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Keywords: Solid Tumor
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2022-01-03
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.

Eligibility 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, 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

Primary outcomes:
measure: Dose Escalation phase Number of participants with dose limiting toxicities (DLTs)
timeFrame: First 21 days of Cycle 1
measure: Dose Escalation and Dose Expansion phase: Number of participants with adverse events
timeFrame: Up to 3 years
measure: Dose Expansion phase: Overall response rate (ORR)
timeFrame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
measure: Expansion phase: Duration of response (DOR)
timeFrame: Up to 3 years
Secondary outcomes:
measure: To characterize the pharmacokinetics(PK) profile of JAB-BX102 as a single agent and in combination with pembrolizumab
timeFrame: Up to 3 years
measure: Dose Escalation phase: Overall response rate (ORR)
timeFrame: Up to 3 years - from baseline to RECIST confirmed Progressive Disease
measure: Dose Escalation phase: Duration of response (DOR)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Disease Control Rate (DCR)
timeFrame: Up to 3 years
measure: Dose Escalation and Dose Expansion phase: Progression-free survival (PFS)
timeFrame: Up to 3 years
Other outcomes:
Locations:
city: Bengbu
country: China
facility: The First Affiliated Hospital of Bengbu Medical College
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences
state: Beijing
city: Beijing
country: China
facility: Peking University Third Hospital
state: Beijing
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
References: