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

Trial ID: NCT04121286

Interventional - Phase 1 - Completed

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.

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

Interventions

• JAB-3312

Eligibility

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. 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

Sponsor

Allist Pharmaceuticals, Inc.

Source: ClinicalTrials.gov

Search more clinical trials on myTomorrows