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NCT Number: NCT04045496

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

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.

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Key information

Conditions

Non-small Cell Lung Cancer Adenocarcinoma Breast Cancer Breast Diseases Breast Neoplasms Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Ductal Carcinoma, Non-Small-Cell Lung Carcinoma, Pancreatic Ductal Carcinoma, Squamous Cell Cardiovascular Abnormalities Cardiovascular Diseases Colonic Diseases Colorectal Cancer Colorectal Neoplasms Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Craniofacial Abnormalities Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Esophageal Diseases Esophageal Neoplasms Esophageal Squamous Cell Carcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Head and Neck Squamous Cell Carcinoma 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, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Noonan Syndrome Other Solid Tumors Pancreatic Diseases Pancreatic Ductal Carcinoma Pancreatic Neoplasms Rectal Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases 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

Primary location

HealthONE Clinic Services Oncology-Hematology, Denver, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
  • Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
  • Subjects with life expectancy ≥3 months.
  • Patients must have at least one measurable lesion as defined by RECIST v1.1.
  • Patients who have sufficient baseline organ function.

Exclusion criteria

  • 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).
  • Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
  • 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.
  • 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
  • History or evidence of active infections (Grade ≥2).
  • History or evidence of significant inflammatory or vascular eye disorder.
  • History of an allogeneic bone marrow or solid organ transplant.
  • 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.
  • 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.
  • History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
  • Subjects experiencing unresolved Grade >1 toxicity before the start of treatment.

Treatment and study plan

JAB-3312

Drug

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

Primary outcomes

  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-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)

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-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.

Sponsors and collaborators

Lead sponsor

Jacobio Pharmaceuticals Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2019
Registry last updated
Dec 29, 2025

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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