A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
- Conditions
- P2: Biliary Tract CancerP1b: Advanced Solid Tumors
- Interventions
- Registration Number
- NCT04492033
- Lead Sponsor
- Handok Inc.
- 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 metastatic solid tumors.
- 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:
Indication of phase 2 study is unresectable advanced, metastatic or recurrent biliary tract cancer (BTC) (including intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma, gallbladder cancer, and ampullary carcinoma).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 41
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CTX-009 (ABL001) and Paclitaxel (P1b) CTX-009 (ABL001) - CTX-009 (ABL001) and Irinotecan (P1b) CTX-009 (ABL001) 1 cycle = 4weeks CTX-009 (ABL001) and Paclitaxel (P2) CTX-009 (ABL001) 1 cycle = 4weeks CTX-009 (ABL001) and Paclitaxel (P1b) Paclitaxel - CTX-009 (ABL001) and Irinotecan (P1b) Irinotecan 1 cycle = 4weeks CTX-009 (ABL001) and Paclitaxel (P2) Paclitaxel 1 cycle = 4weeks
- Primary Outcome Measures
Name Time Method P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT) From Day 1 until disease progression or Day 28, whichever came first Number of subjects who experience DLT events during 28 days after first administration of CTX-009 (ABL001) and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects
P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC Up to approximately 24 months The proportion of subjects whose best overall response (BOR) is assessed to be complete response (CR) or partial response (PR) as per Independent Radiology Center's review
- Secondary Outcome Measures
Name Time Method Progression-free survival (PFS) Up to approximately 24 months The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death
Duration of response (DOR) Up to approximately 24 months Time interval from first occurrence of a documented objective response to the time of disease progression
P2: Survival rate 6 months and 12 months The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment
Pharmacokinetics (PK) of CTX-009 (ABL001) Up to approximately 24 months Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)
Adverse Events (AEs) Up to approximately 24 months Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Objective response rate (ORR) Up to approximately 24 months Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review
Disease control rate (DCR) Up to approximately 24 months Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)
Time to treatment failure (TTF) Up to approximately 24 months Time interval from 1st administration of CTX-009 (ABL001) to the time of disease progression or discontinuation of CTX-009 (ABL001) due to whatever reason, whichever comes first
P2: Overall survival (OS) Up to approximately 24 months Time from the initiation of treatment to death
Trial Locations
- Locations (4)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of