JAB-3068 Activity in Adult Patients With Advanced Solid Tumors

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

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

Study Overview

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

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 Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Beijing Cancer Hospital
    • Beijing, Beijing, China
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
  • Henan
    • Zhengzhou, Henan, China
      • Recruiting
      • Henan Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: JAB-3068+PD1 inhibitor Part1; JAB-3068+JS001 dose escalation	Drug: JAB-3068; JAB-3068 administrated orally as a tablet.; Drug: PD1 inhibitor; JS001 administrated as an intravenous(IV) infusion.
Experimental: JAB-3068+PD1 inhibitor Part2; JAB-3068+JS001 dose expansion	Drug: JAB-3068; JAB-3068 administrated orally as a tablet.; Drug: PD1 inhibitor; JS001 administrated as an intravenous(IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Objective response rate (ORR)	ORR is defined as the proportion of participants with complete response or partial response (CR+PR).	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma concentration (Cmax)	Highest observed plasma concentration of JAB-3068 and JS001	24 months
Time to achieve Cmax (Tmax)	Time of highest observed plasma concentration of JAB-3068 and JS001	24 months
Area under the plasma concentration-time curve (AUC)	Area under the plasma concentration time curve of JAB-3068 and JS001	24 months
Duration of response ( DCR )	DCR is defined as proportion of participants with complete response, partial response, stable disease(CR+PR+SD).	24 months
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
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
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
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

Collaborators and Investigators

• Sponsor: Jacobio Pharmaceuticals Co., Ltd.
• Collaborators: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2021
• Primary Completion (Anticipated): February 28, 2022
• Study Completion (Anticipated): October 28, 2022

Study Registration Dates

• First Submitted: January 14, 2021
• First Submitted That Met QC Criteria: January 20, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 26, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Neoplasms, Squamous Cell; Esophageal Neoplasms; Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck; Esophageal Squamous Cell Carcinoma; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents; Immune Checkpoint Inhibitors
• Other Study ID Numbers: JAB-3068-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No