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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Sequential Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 2020

Interventions

  • Drug: JAB-3312
    • JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
    • Time Frame: Approximately 2 years
    • 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.
  • Find Recommended Phase 2 Dose (RP2D) of JAB-3312
    • Time Frame: Approximately 2 years
    • Measurements of MTD (i.e. the highest dose of JAB-3068 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)

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Jacobio Pharmaceuticals Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yuankai Shi, MD, Principal Investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  • Overall Contact(s)
    • Yuankai Shi, MD, 86 010 87788293, syuankaipumc@126.com

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