JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

Non Small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1b/2a, Multi-Center, Open-Label，Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of JAB-3068 in Combination With JS001 in Patients With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04721223
• Other study ID #: JAB-3068-03
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 26, 2021
• Est. completion date: October 28, 2022

Study information

• Verified date: July 2021
• 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-3068 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-3068 in combination with PD1 inhibitor in patients with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: October 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analyses.
• Participant must be =18 years of age at the time of signature of the informed consent form (ICF).
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Exclusion Criteria:

• History (=3 years) of cancer that is histologically distinct from the cancers under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I non-melanoma skin cancer
• Known serious allergy to experimental drugs
• Brain or spinal metastases, except if treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no evidence of progression or hemorrhage for =21 days before the start of treatment with the study drugs, and has not received any systemic corticosteroids for =21 days before the start of treatment with the study drugs

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Cell Carcinoma
• Head and Neck Squamous Cell Carcinoma
• Non Small Cell Lung Cancer
• Squamous Cell Carcinoma of Head and Neck

Intervention

Drug:
• JAB-3068
JAB-3068 administrated orally as a tablet.
• PD1 inhibitor
JS001 administrated as an intravenous(IV) infusion.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing
China	Henan Cancer Hospital	Zhengzhou	Henan

Sponsors (2)

Lead Sponsor	Collaborator
Jacobio Pharmaceuticals Co., Ltd.	AbbVie

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with dose limiting toxicities	Incidence of dose limiting toxicities (DLTs) . 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 with JAB-3068 and JS001.	24 months
Primary	Objective response rate (ORR)	ORR is defined as the proportion of participants with complete response or partial response (CR+PR).	24 months
Secondary	Plasma concentration (Cmax)	Highest observed plasma concentration of JAB-3068 and JS001	24 months
Secondary	Time to achieve Cmax (Tmax)	Time of highest observed plasma concentration of JAB-3068 and JS001	24 months
Secondary	Area under the plasma concentration-time curve (AUC)	Area under the plasma concentration time curve of JAB-3068 and JS001	24 months
Secondary	Duration of response ( DCR )	DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).	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.	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.	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.	24 months
Secondary	Number of Participants with Treatment-related Adverse Events(TRAE)	TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug.	24 months