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NCT Number: NCT03565003

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

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.

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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 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, Beijing Municipality, China

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About this study

Dose escalation study phase is designed to determine the maximum tolerated dose (MTD) according to a 3+3 design and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of JAB-3068. Other dose regimens may be explored based on the analysis of emerging PK and safety data. at this study phase, JAB-3068 dministered orally once daily (QD) or twice daily (BID) or once every other day (QOD) in 28-day treatment cycles to adult patients with advanced solid tumors,

Dose expansion study phase is designed to evaluate the antitumor activity(ORR and DOR) of JAB-3068 in patients with NSCLC, ESCC and HNSCC.

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;
  • 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.

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;
  • 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.

Treatment and study plan

JAB-3068

Drug

25 mg,100 mg

Primary outcomes

  1. Number of participants with dose limiting toxicities

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

    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.

  2. Objective response rate

    Time frame: Approximately 2 years

    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

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

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) in dose escalation.

  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 in dose escalation.

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

A Phase 1/2a, Multi-Center, Dose Escalation/Dose Expansion, 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
2023
Study completion
2023
First posted
Jun 21, 2018
Registry last updated
Sep 25, 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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