Status:
TERMINATED
A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
Lead Sponsor:
Handok Inc.
Collaborating Sponsors:
Compass Therapeutics
ABL Bio, Inc.
Conditions:
P1b: Advanced Solid Tumors
P2: Biliary Tract Cancer
Eligibility:
All Genders
19+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is a Phase 1b/2 multi-center study to assess the safety, tolerability, pharmacokinetics of CTX-009 (ABL001) in combination with Irinotecan or Paclitaxel in patients with advanced or metasta...
Detailed Description
Phase 1b Study: Indication of phase 1b study is the advanced or metastatic solid tumors (including, but not limited to, colorectal cancer, gastric cancer, and ovarian cancer). Phase 2 Study: Indica...
Eligibility Criteria
Inclusion
- Key
- P1b only: Patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
- P2 only: Patients with histologically or cytologically confirmed unresectable advanced, metastatic, or recurrent biliary tract cancers (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, including treatment with gemcitabine in combination with a platinum agent
- Patients aged 19 years or older
- At least one lesion measurable defined by 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
- 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 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 major and unhealed injury (active ulcer, untreated fracture)
- 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 initiation of study treatment and received an investigational drug treatment
- 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
Key Trial Info
Start Date :
June 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 9 2025
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04492033
Start Date
June 22 2020
End Date
January 9 2025
Last Update
January 27 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Seoul National University Bundang Hospital
Seongnam-si, South Korea
2
Asan Medical Center
Seoul, South Korea
3
Samsung Medical Center
Seoul, South Korea
4
Seoul National University Hospital
Seoul, South Korea