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Clinical Trial Record

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A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China

2020-07-14

2022-06-17

2022-06-17

17

Study Overview

A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China

This is a Phase 1, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.

N/A

  • Non-small Cell Lung Cancer
  • Colorectal Cancer
  • Pancreatic Ductal Carcinoma
  • Esophageal Squamous Cell Carcinoma
  • Head and Neck Squamous Cell Carcinoma
  • Breast Cancer
  • Other Solid Tumors
  • DRUG: JAB-3312
  • JAB-3312-1002

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-09-29  

N/A  

2025-05-15  

2019-10-08  

N/A  

2025-05-20  

2019-10-09  

N/A  

2025-02  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Sequential

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: JAB-3312

JAB-3312 will be administered orally once daily in 21 days treatment cycles.

DRUG: JAB-3312

  • JAB-3312 will be supplied as 0.25 mg, 1.0 mg and 4.0 mg capsules.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Number of participants with dose limiting toxicitiesIncidence 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-3312.Approximately 2 years
Find Recommended Phase 2 Dose (RP2D) of JAB-3312Measurements of MTD (i.e. the highest dose of JAB-3312 associated with the occurrence of Dose Limiting Toxicities (DLTs) in <33% of patients) or the RP2D (i.e. the highest tested dose that is declared safe and tolerable by the Investigators and Sponsor)Approximately 2 years
Secondary Outcome MeasuresMeasure DescriptionTime Frame
Number of participants with adverse eventsAll 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 assessmentsApproximately 2 years
Area under the curveArea under the plasma concentration time curve of JAB-3312Approximately 2 years
CmaxHighest observed plasma concentration of JAB-3312Approximately 2 years
TmaxTime of highest observed plasma concentration of JAB-3312Time of highest observed plasma concentration of JAB-3312
T1/2Half life of JAB-3312Approximately 2 years
Objective response rate ( ORR )ORR is defined as the proportion of participants with complete response or partial response (CR+PR)Approximately 2 years
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.Approximately 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF). 2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1. 3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists. 4. Subjects with life expectancy ≥3 months. 5. Patients must have at least one measurable lesion as defined by RECIST v1.1. 6. Patients who have sufficient baseline organ function
    Exclusion Criteria:
    1. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone >10 mg/day or equivalent). 2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases. 3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain. 4. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV). 5. History or evidence of active infections (Grade ≥2). 6. History or evidence of significant inflammatory or vascular eye disorder. 7. History of an allogeneic bone marrow or solid organ transplant. 8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312. 9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312. 10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment. 11. Subjects experiencing unresolved Grade >1 toxicity before the start of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

    • PRINCIPAL_INVESTIGATOR: Yuankai Shi, MD, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    No publications available

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