A Study of JAB-3312 in Adult Patients With Advanced Solid Tumors in China
About the study
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.
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
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
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.
- 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
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study Details
Contition
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
Age
18+
Phase
PHASE1
Participants Needed
24
Est. Completion Date
Dec 31, 2023
Treatment Type
INTERVENTIONAL
Sponsor
Jacobio Pharmaceuticals Co., Ltd.
ClinicalTrials.gov NCT Identifier
NCT04121286
Study Number
JAB-3312-1002
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