Clinical Trials /

A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors

NCT04045496

Description:

This is a Phase 1, first-in-human, 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.

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
  • Official Title: A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients With Advanced Solid Tumors

Clinical Trial IDs

  • ORG STUDY ID: JAB-3312-1001
  • NCT ID: NCT04045496

Conditions

  • 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

Interventions

DrugSynonymsArms
JAB-3312JAB-3312

Purpose

This is a Phase 1, first-in-human, 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.

Trial Arms

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

Eligibility Criteria

        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. 8. 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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with dose limiting toxicities
Time Frame:Approximately 2 years
Safety Issue:
Description: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-3312.

Secondary Outcome Measures

Measure:Number of participants with adverse events
Time Frame:Approximately 2 years
Safety Issue:
Description: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
Measure:Area under the curve
Time Frame:Approximately 2 years
Safety Issue:
Description:Area under the plasma concentration time curve of JAB-3312
Measure:Cmax
Time Frame:Approximately 2 years
Safety Issue:
Description:Highest observed plasma concentration of JAB-3312
Measure:Tmax
Time Frame:Approximately 2 years
Safety Issue:
Description:Time of highest observed plasma concentration of JAB-3312
Measure:T1/2
Time Frame:Approximately 2 years
Safety Issue:
Description:Half life of JAB-3312
Measure:Objective response rate ( ORR )
Time Frame:Approximately 2 years
Safety Issue:
Description:ORR is defined as the proportion of participants with complete response or partial response (CR+PR)
Measure:Duration of response ( DOR )
Time Frame:Approximately 2 years
Safety Issue:
Description: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.

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Jacobio Pharmaceuticals Co., Ltd.

Trial Keywords

  • Src homology phosphatase 2 (SHP2)
  • PTPN11
  • Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase
  • epidermal growth factor receptor (EGFR)

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