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

Completed · Phase 1

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT04045496

Run by

Jacobio Pharmaceuticals Co., Ltd.

People needed

40

Starts

2019-09-26

Expected to finish

2022-12-16

Last updated by the study team

2025-12-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• HealthONE Clinic Services Oncology-Hematology — Denver, Colorado, United States
• Tennessee Oncology, PLLC — Nashville, Tennessee, United States
• The University of Texas M. D. Anderson Cancer Center — Houston, Texas, United States
• Washington University School of Medicine — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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