Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04045496
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Jacobio Pharmaceuticals Co., Ltd.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : September 26, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : August 2021


Arm Intervention/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 and 1.0 mg capsules.




Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities [ 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.

  2. 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 Outcome Measures :
  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-3312

  3. Cmax [ Time Frame: Approximately 2 years ]
    Highest observed plasma concentration of JAB-3312

  4. Tmax [ Time Frame: Approximately 2 years ]
    Time of highest observed plasma concentration of JAB-3312

  5. T1/2 [ Time Frame: Approximately 2 years ]
    Half life of JAB-3312

  6. 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)

  7. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04045496


Contacts
Layout table for location contacts
Contact: Jacobio Pharmaceuticals 86 10 56315466 clinicaltrials@jacobiopharma.com

Locations
Layout table for location information
United States, Colorado
HealthONE Clinic Services Oncology-Hematology Recruiting
Denver, Colorado, United States, 80202
Contact: Shiraj Sen, MD         
United States, Tennessee
Tennessee Oncology, PLLC Recruiting
Nashville, Tennessee, United States, 37203
Contact: Meredith McKean, MD         
United States, Texas
The University of Texas M. D. Anderson Cancer Center Not yet recruiting
Houston, Texas, United States, 77030
Contact: Sarina A. Piha-Paul, MD         
Sponsors and Collaborators
Jacobio Pharmaceuticals Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Jacobio Pharmaceuticals Jacobio Pharmaceuticals

Layout table for additonal information
Responsible Party: Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov Identifier: NCT04045496     History of Changes
Other Study ID Numbers: JAB-3312-1001
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jacobio Pharmaceuticals Co., Ltd.:
Src homology phosphatase 2 (SHP2)
PTPN11
Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase
epidermal growth factor receptor (EGFR)
Additional relevant MeSH terms:
Layout table for MeSH terms
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Esophageal Squamous Cell Carcinoma
Carcinoma, Ductal
Carcinoma, Pancreatic Ductal
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Neoplasms, Squamous Cell
Head and Neck Neoplasms
Esophageal Neoplasms
Esophageal Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Pancreatic Neoplasms
Endocrine Gland Neoplasms
Pancreatic Diseases
Endocrine System Diseases