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

NCT04045496 | Completed Phase 1 FDA Drug

• 1 other identifier: JAB-3312-1001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

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.

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Number of participants with dose limiting toxicities

  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.

  Approximately 2 years

• Find Recommended Phase 2 Dose (RP2D) of JAB-3312

  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)

  Approximately 2 years

Secondary Outcomes (7)

• Number of participants with adverse events

  Approximately 2 years

• Area under the curve

  Approximately 2 years

• Cmax

  Approximately 2 years

• Tmax

  Approximately 2 years

• T1/2

  Approximately 2 years

Study Arms (1)

JAB-3312

EXPERIMENTAL

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

Drug: JAB-3312

Interventions

JAB-3312 DRUG

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

JAB-3312

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. 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.

Sponsors & Collaborators

• Jacobio Pharmaceuticals Co., Ltd.: lead

Study Sites (4)

HealthONE Clinic Services Oncology-Hematology

Denver, Colorado, 80202, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203, United States

Location

The University of Texas M. D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Washington University School of Medicine

Seattle, Washington, 63110, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Carcinoma, Pancreatic Ductal; Esophageal Squamous Cell Carcinoma; Squamous Cell Carcinoma of Head and Neck; Breast Neoplasms; Noonan Syndrome

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Ductal; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Pancreatic Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma, Squamous Cell; Neoplasms, Squamous Cell; Esophageal Neoplasms; Head and Neck Neoplasms; Esophageal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases

Study Officials

• Jacobio Pharmaceuticals

  Jacobio Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 2, 2019
• First Posted: August 5, 2019
• Study Start: September 26, 2019
• Primary Completion: December 16, 2022
• Study Completion: December 16, 2022
• Last Updated: December 29, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)