JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

Phase 1

• Conditions: Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Advanced Solid Tumor; Esophageal Squamous Cell Carcinoma
• Interventions: Drug: JAB-3068; Drug: PD1 inhibitor

• Registration Number: NCT04721223
• Lead Sponsor: Jacobio Pharmaceuticals Co., Ltd.

Brief Summary

To evaluate the safety and tolerability of JAB-3068 administered in investigational regimens in adult participants with advanced solid tumors.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-01-14
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Study Start: 2021-04-26
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-26
• Last Update Posted: 2021-07-28
• Primary Completion: 2022-02-28
• Study Completion: 2022-10-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
JAB-3068+PD1 inhibitor Part1	PD1 inhibitor	JAB-3068+JS001 dose escalation
JAB-3068+PD1 inhibitor Part2	JAB-3068	JAB-3068+JS001 dose expansion
JAB-3068+PD1 inhibitor Part1	JAB-3068	JAB-3068+JS001 dose escalation
JAB-3068+PD1 inhibitor Part2	PD1 inhibitor	JAB-3068+JS001 dose expansion

Primary Outcome Measures

Name	Time	Method
Number of participants with dose limiting toxicities	24 months	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.
Objective response rate (ORR)	24 months	ORR is defined as the proportion of participants with complete response or partial response (CR+PR).

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Treatment-related Adverse Events(TRAE)	24 months	TRAE is defined as the AES that the casual relationship of the AE is ralated to investigational drug.
Area under the plasma concentration-time curve (AUC)	24 months	Area under the plasma concentration time curve of JAB-3068 and JS001
Duration of response ( DOR )	24 months	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.
Overall survival (OS)	24 months	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.
Time to achieve Cmax (Tmax)	24 months	Time of highest observed plasma concentration of JAB-3068 and JS001
Duration of response ( DCR )	24 months	DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).
Plasma concentration (Cmax)	24 months	Highest observed plasma concentration of JAB-3068 and JS001
Progression-free survival (PFS)	24 months	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.

Trial Locations

Locations (3)

Beijing Cancer Hospital; 🇨🇳 Beijing, Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China