A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: P1b: Advanced Solid Tumors; P2: Biliary Tract Cancer
• Intervention / Treatment: Drug: CTX-009 (ABL001); Drug: Paclitaxel; Drug: Irinotecan

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).

• Study Type: Interventional
• Enrollment (Estimated): 92
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: HyunJoo Son; Phone Number: +82-2-527-5257; Email: HyunJoo.Son@handok.com

Study Locations

• Korea, Republic of
  • Seongnam-si, Korea, Republic of
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Seoul National University Hospital
  • Seoul, Korea, Republic of
    • Asan Medical Center
  • Seoul, Korea, Republic of
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Key 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 1.1.
• 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CTX-009 (ABL001) and Paclitaxel (P1b)	Drug: CTX-009 (ABL001); CTX-009 (ABL001) will be administered biweekly.; Drug: Paclitaxel; Paclitaxel will be administered weekly.
Experimental: CTX-009 (ABL001) and Irinotecan (P1b); 1 cycle = 4weeks	Drug: CTX-009 (ABL001); CTX-009 (ABL001) will be administered biweekly.; Drug: Irinotecan; Irinotecan will be administered biweekly.
Experimental: CTX-009 (ABL001) and Paclitaxel (P2); 1 cycle = 4weeks	Drug: CTX-009 (ABL001); CTX-009 (ABL001) will be administered biweekly.; Drug: Paclitaxel; Paclitaxel will be administered weekly.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
P1b: Proportion of subjects with Dose-Limiting Toxicity (DLT)	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	From Day 1 until disease progression or Day 28, whichever came first
P2: Objective response rate (ORR) of CTX-009 (ABL001) in combination with paclitaxel in patients with BTC	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	Up to approximately 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AEs)	Severity of AEs will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	Up to approximately 24 months
Pharmacokinetics (PK) of CTX-009 (ABL001)	Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)	Up to approximately 24 months
Objective response rate (ORR)	Proportion of subject with best overall response of complete response (CR) or partial response (PR) as per investigator's review	Up to approximately 24 months
Disease control rate (DCR)	Proportion of subjects with a best overall response of complete response (CR), partial response (PR) or stable disease (SD)	Up to approximately 24 months
Time to treatment failure (TTF)	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	Up to approximately 24 months
Duration of response (DOR)	Time interval from first occurrence of a documented objective response to the time of disease progression	Up to approximately 24 months
Progression-free survival (PFS)	The time from the initiation of treatment to the first radiologic assessment that confirms progression of tumor or to death	Up to approximately 24 months
P2: Survival rate	The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment	6 months and 12 months
P2: Overall survival (OS)	Time from the initiation of treatment to death	Up to approximately 24 months

Collaborators and Investigators

• Sponsor: Handok Inc.
• Collaborators: ABL Bio, Inc.; Compass Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2020
• Primary Completion (Actual): November 22, 2023
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): July 30, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: VEGF; Solid Tumors; Bispecific antibody; DLL4; anti-angiogenic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Biliary Tract Diseases; Biliary Tract Neoplasms; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Antineoplastic Agents, Phytogenic; Topoisomerase Inhibitors; Topoisomerase I Inhibitors; Paclitaxel; Irinotecan
• Other Study ID Numbers: ABL001-P1bC; CTX-009-001 (Other Identifier: Compass Therapeutics)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No