A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China

NCT03565003 | Completed Phase 1

• 1 other identifier: JAB-3068-02
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 4

Brief Summary

This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.

Conditions

Non-small Cell Lung Cancer; Head and Neck Cancer; Esophageal Cancer; Other Metastatic Solid Tumors

Keywords

JAB-3068; SHP2; PTPN11; ESCC; NSCLC; HNSCC; Colorectal cancer (CRC); EGFR

Outcome Measures

Primary Outcomes (3)

• Number of participants with dose limiting toxicities

  Number of participants with 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 with JAB-3068.

  At the end of Cycle 1 (each cycle is 28 days)

• Objective response rate

  ORR is defined as the proportion of participants with complete response or partial. the ORR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion

  Approximately 2 years

• Duration of response

  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. The DOR of JAB-3068 in patients with ESCC, NSCLC and HNSCC will be evaluated separately in dose expansion

  Approximately 2 years

Secondary Outcomes (7)

• Number of participants with adverse events

  Approximately 2 years

• Area under the curve

  Approximately 2 years

• Cmax

  Approximately 2 years

• Tmax

  Approximately 2 years

• T1/2

  Approximately 2 years

Study Arms (1)

JAB-3068 (SHP2 inhibitor)

EXPERIMENTAL

JAB-3068 will be administered orally in the morning following a fast of approximately 6 hours before on PK collection. Patients will continue to fast for approximately 2 hours after the administration of JAB-3068. On non-PK days patients will fast approximately 2 hours before JAB-3068 and continue to fast for approximately 2 hours afterwards.

Drug: JAB-3068

Interventions

JAB-3068 DRUG

25 mg,100 mg

JAB-3068 (SHP2 inhibitor)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained prior to any study-related procedure being performed;
• Age 18 years or older;
• Dose escalation(phase I): Patients with histologically or cytologically confirmed, advanced solid tumors (including lymphoma) which have progressed from standard therapy or for whom no standard therapy exists; Dose expansion(phase IIa ): Patients with histologically or cytologically confirmed, advanced NSCLC, ESCC, HNSCC which have progressed from standard therapy;
• Patients with life expectancy ≥3 months;
• Dose expansion(phase IIa ): patients have available archival tissue can be provided or willing to perform biopsy to provide fresh tumor tissue.
• Patients with other solid tumors must have at least one measurable lesion as defined by RECIST v1.1;Patients with Lymphomas must have at least one measurable lesion as defined by IWG 2007 criteria;
• Eastern Cooperative Oncology Group performance score 0 or 1;
• Patients who have sufficient baseline organ function.

You may not qualify if:

• Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
• History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
• Lymphoma with brain metastasis; Other solid tumors:Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
• Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study
• Patients who have impaired cardiac function or clinically significant cardiac diseases
• Use of anti-cancer treatment drug ≤21 days prior to the first dose of JAB-3068.
• Use of an investigational drug during the past 30 days prior to the first dose of JAB-3068.

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (4)

Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

Location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Chinese PLA Central Hospital

Beijing, Beijing Municipality, 100853, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms; Esophageal Neoplasms; Noonan Syndrome; Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Yuankai Shi, MD

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2018
• First Posted: June 21, 2018
• Study Start: November 20, 2018
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: September 25, 2024

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)