A Phase 1b/2a 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
Overview
- Phase
- Phase 1
- Intervention
- CTX-009 (ABL001)
- Conditions
- P1b: Advanced Solid Tumors
- Sponsor
- Handok Inc.
- Enrollment
- 41
- Locations
- 4
- Primary Endpoint
- P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)
- Status
- Terminated
- Last Updated
- last year
Overview
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
- •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
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 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
Arms & Interventions
CTX-009 (ABL001) and Paclitaxel (P1b)
Intervention: CTX-009 (ABL001)
CTX-009 (ABL001) and Paclitaxel (P1b)
Intervention: Paclitaxel
CTX-009 (ABL001) and Irinotecan (P1b)
1 cycle = 4weeks
Intervention: CTX-009 (ABL001)
CTX-009 (ABL001) and Irinotecan (P1b)
1 cycle = 4weeks
Intervention: Irinotecan
CTX-009 (ABL001) and Paclitaxel (P2)
1 cycle = 4weeks
Intervention: CTX-009 (ABL001)
CTX-009 (ABL001) and Paclitaxel (P2)
1 cycle = 4weeks
Intervention: Paclitaxel
Outcomes
Primary Outcomes
P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)
Time Frame: 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
Time Frame: 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 Outcomes
- Progression-free survival (PFS)(Up to approximately 24 months)
- Duration of response (DOR)(Up to approximately 24 months)
- P2: Survival rate(6 months and 12 months)
- Pharmacokinetics (PK) of CTX-009 (ABL001)(Up to approximately 24 months)
- Adverse Events (AEs)(Up to approximately 24 months)
- Objective response rate (ORR)(Up to approximately 24 months)
- Disease control rate (DCR)(Up to approximately 24 months)
- Time to treatment failure (TTF)(Up to approximately 24 months)
- P2: Overall survival (OS)(Up to approximately 24 months)