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Completed

NCT Number: NCT03518554

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

This is a phase 1, multi-center, dose escalation, open-label study to evaluate the safety, tolerability, pharmacokinetics, and preliminary evidence of antitumor activity of JAB-3068 in adult patients with advanced solid.

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Carcinoma, Squamous Cell Cardiovascular Abnormalities Cardiovascular Diseases Colonic Diseases Colorectal Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Craniofacial Abnormalities Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Heart Defects, Congenital Heart Diseases Intestinal Diseases Intestinal Neoplasms Lung Diseases Lung Neoplasms Musculoskeletal Abnormalities Musculoskeletal Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Noonan Syndrome Other Metastatic Solid Tumors Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin and Connective Tissue Diseases Squamous Cell Carcinoma of Head and Neck Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HealthONE Clinic Services Oncology-Hematology, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Written informed consent obtained prior to any study-related procedure being performed;
  • Age 18 years or older;
  • Patients with histologically or cytologically confirmed, advanced solid tumors which have progressed despite standard therapy or for whom no standard therapy exists;
  • Patients with life expectancy ≥3 months;
  • Patients must have at least one measurable lesion as defined by RECIST v1.1;
  • Eastern Cooperative Oncology Group performance score 0 or 1;
  • Patients who have sufficient baseline organ function.

Exclusion criteria

  • 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;
  • 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 or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
  • Use of an investigational drug during the past 30 days or 5 half-lives (whichever is shorter) prior to the first dose of JAB-3068;
  • No other anti-cancer therapy (chemotherapy, immunotherapy, hormonal therapy radiotherapy (except for palliative local radiotherapy), biological therapy or other novel agent is to be permitted while the patient is receiving study medication.

Treatment and study plan

JAB-3068

Drug

JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.

Primary outcomes

  1. Number of participants with dose limiting toxicities

    Time frame: up to 28-day per cycle

    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 with JAB-3068.

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: Approximately 2 years

    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

  2. Area under the curve

    Time frame: Approximately 2 years

    Area under the plasma concentration time curve of JAB-3068

  3. Cmax

    Time frame: Approximately 2 years

    Highest observed plasma concentration of JAB-3068

  4. Tmax

    Time frame: Approximately 2 years

    Time of highest observed plasma concentration of JAB-3068

  5. T1/2

    Time frame: Approximately 2 years

    Half life of JAB-3068

  6. Objective response rate

    Time frame: Approximately 2 years

    ORR is defined as the proportion of participants with complete response or partial response (CR+PR)

  7. Duration of response

    Time frame: Approximately 2 years

    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.

Other outcomes

  1. pERK

    Time frame: Approximately 2 years

    On treatment versus baseline comparison of pharmacodynamic marker pERK (Phosphorylated form of Extracellular signal-regulated kinase) on newly obtained tumor biopsy samples by IHC.

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase 1, Multi-Center, Dose Escalation, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3068 in Adult Patients With Advanced Solid Tumors

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
May 8, 2018
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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