JAB-3312 Based Combination Therapy in Adult Patients With Advanced Solid Tumors

Solid Tumor Clinical Trial

Official title:

A Phase 1/2a, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 Based Combination Therapies in Adult Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04720976
• Other study ID #: JAB-3312-1003
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 23, 2021
• Est. completion date: February 5, 2024

Study information

• Verified date: May 2023
• Source: Jacobio Pharmaceuticals Co., Ltd.
• Contact: Jacobio Pharmaceuticals
• Phone: 86 10 56315466
• Email: clinicaltrials[@]jacobiopharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the safety and tolerability of JAB-3312 administered in investigational regimens in adult participants with advanced solid tumors.

Description:

To assess the safety and tolerability and determine the Recommended phase 2 dose (RP2D) of JAB-3312 in combination with PD1 inhibitor or MEK inhibitor in patients with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 5, 2024
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Must have histologically or cytologically confirmed metastatic or locally advanced solid tumor. Some cohorts must meet specific expression or gene mutation where indicated

• Sufficient organ function

• Participants must have at least 1 measurable lesion as defined by RECIST v1.1

• Must be able to provide an archived tumor sample

• ECOG performance status score of 0 or 1.

Exclusion Criteria:

• History of cancer that is histologically distinct from the cancers under study

• Active or untreated central nervous system (CNS) metastases

• History of pneumonitis or interstitial lung disease (ILD)

• Has active hepatitis B, hepatitis C infection, HIV

• Any severe and/or uncontrolled medical conditions

• LVEF =50%

• QTcF >470 msec

Related Conditions & MeSH terms

• Neoplasms
• NSCLC
• Solid Tumor

Intervention

Drug:
• JAB-3312
JAB-3312 will be administered orally, variable dose.
• Binimetinib
Binimetinib will be administered orally.
• Pembrolizumab
Pembrolizumab will be administered as an intravenous infusion.
• Sotorasib
Sotorasib will be administered orally.
• Osimertinib
Osimertinib will be administered orally.

Locations

Country	Name	City	State
United States	Research Site	Chicago	Illinois
United States	Research Site	Detroit	Michigan
United States	Research Site	Houston	Texas
United States	Research Site	Indianapolis	Indiana
United States	Research Site	Jacksonville	Florida
United States	Research Site	Los Angeles	California
United States	Research Site	New Haven	Connecticut
United States	Research Site	New York	New York
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orange City	Florida
United States	Research Site	Phoenix	Arizona
United States	Research Site	Rochester	Minnesota
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Salt Lake City	Utah
United States	Research Site	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose limiting toxicities	Incidence of dose limiting toxicities (DLTs) in the dose escalation phase. A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle. (Dose escalation phase)	24 months
Primary	Objective response rate (ORR)	ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose expansion phase)	24 months
Primary	Duration of response (DOR)	DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose expansion phase)	24 months
Primary	Duration of response (DCR)	DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose expansion phase)	24 months
Primary	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 or death which occurs first. (Dose expansion phase)	24 months
Primary	Overall survival (OS)	OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor. (Dose expansion phase)	24 months
Primary	Number of participants with adverse events	All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose escalation phase)	24 months
Secondary	Objective response rate (ORR)	ORR is defined as the proportion of participants with complete response or partial response (CR+PR). (Dose escalation phase)	24 months
Secondary	Duration of response (DOR)	DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first. (Dose escalation phase)	24 months
Secondary	Duration of response (DCR)	DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD). (Dose escalation phase)	24 months
Secondary	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 or death which occurs first. (Dose escalation phase)	24 months
Secondary	Overall survival (OS)	OS is defined as the interval of time between the date of first treatment until death, loss to follow up or termination of the study by the sponsor(Dose escalation phase)	24 months
Secondary	Plasma concentration (Cmax)	Highest observed plasma concentration of JAB-3312(dose escalation phase)	24 months
Secondary	Time to achieve Cmax (Tmax)	Time of highest observed plasma concentration of JAB-3312(dose escalation phase)	24 months
Secondary	Area under the plasma concentration-time curve (AUC)	Area under the plasma concentration time curve of JAB-3312(dose escalation phase)	24 months
Secondary	Number of participants with adverse events	All patients participating in this study will be assessed for incidence and severity of adverse events (AEs) and serious AEs, including changes in laboratory values, vital signs, electrocardiograms, cardiac imaging and ophthalmological assessments (Dose expansion phase)	24 months