A Study of ABL001 in Combination With Irinotecan or Paclitaxel in Patients With Advanced or Metastatic Solid Tumors

• Status: Recruiting
• Trial end date: 2024-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of ABL001 in combination with Irinotecan or Paclitaxel in patients with advanced or metastatic solid tumors.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ABL Bio, Inc.; Handok Inc.
• Collaborators: ABL Bio, Inc.; National OncoVenture
• Treatments: Irinotecan; Niacinamide; Paclitaxel

Criteria

Key Inclusion Criteria:

• P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors

• P2 only: Patients histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancer (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, ampullary carcinoma)

• P2 only: Patients who have shown disease progress or recurrence of disease after receiving first-line or second-line systemic chemotherapy.

• Patients aged 19 years or older

• Lesions measured by tumor markers or by CT/MRI must be evaluable based on response evaluation criteria in solid tumors (RECIST) version 1.1.

• Life expectancy ≥ 12 weeks

• ECOG performance status 0 or 1

• Women of childbearing potential must have a negative pregnancy test outcome

• Patients must provide written informed consent to voluntary participation in this study

Key Exclusion Criteria:

• History of hypersensitivity reactions to any of the components of the investigational product or other drugs of the same class (humanized/human monoclonal antibody) and irinotecan or paclitaxel

• Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery

• History of cardiac illness: New York Heart Association (NYHA) class ≥ II congestive heart failure (CHF), uncontrolled hypertension, hypertension crisis, pulmonary hypertension, myocardial infarction, uncontrolled arrhythmia, unstable angina

• Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy

• Severe infections or severe traumatic systemic disorders

• Symptomatic or uncontrolled central nervous system (CNS) metastasis

• Pregnant or lactating women or patients planning to become pregnant during the study

• Participation in another clinical trial within 30 days prior to screening

• Administration of antiplatelets or anticoagulants within 2 weeks prior to screening

• Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids

• HIV or other severe diseases that warrant the exclusion from this study