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

• ClinicalTrials.gov Identifier: NCT04492033
• Recruitment Status: Active, not recruiting
• First Posted: July 30, 2020
• Last Update Posted: December 28, 2023
• Sponsor: Handok Inc.
• Collaborators: Compass Therapeutics; ABL Bio, Inc.
• Information provided by (Responsible Party): Handok Inc.

Tracking Information

• First Submitted Date: June 15, 2020
• First Posted Date: July 30, 2020
• Last Update Posted Date: December 28, 2023
• Actual Study Start Date: June 22, 2020
• Actual Primary Completion Date: November 22, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 26, 2022)

• 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

Original Primary Outcome Measures (submitted: July 29, 2020)

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 ABL001 and Irinotecan/Paclitaxel, divided by the number of DLT-evaluable subjects

Current Secondary Outcome Measures (submitted: June 26, 2022)

• Adverse Events (AEs) [ Time Frame: 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
• Pharmacokinetics (PK) of CTX-009 (ABL001) [ Time Frame: Up to approximately 24 months ]
  Serum concentrations of CTX-009 (ABL001) will be collected and analyzed to evaluate the PK of CTX-009 (ABL001)
• Objective response rate (ORR) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: 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
• Duration of response (DOR) [ Time Frame: Up to approximately 24 months ]
  Time interval from first occurrence of a documented objective response to the time of disease progression
• Progression-free survival (PFS) [ Time Frame: 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
• P2: Survival rate [ Time Frame: 6 months and 12 months ]
  The proportion of subjects who have survived at 6 months and 12 months from the initiation of treatment
• P2: Overall survival (OS) [ Time Frame: Up to approximately 24 months ]
  Time from the initiation of treatment to death

Original Secondary Outcome Measures (submitted: July 29, 2020)

• Pharmacokinetics (PK) of ABL001 [ Time Frame: from date of 1st administration of ABL001 until the date of 1st documented progression, whichever came first, assessed up to 24 months ]
  Serum concentrations of ABL001 will be collected and analyzed to evaluate the PK of ABL001
• Objective response rate [ Time Frame: from date of 1st administration of ABL001 until the date of 1st documented progression, whichever came first, assessed up to 24 months ]
  proportion of subject with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1
• Disease control rate [ Time Frame: from date of 1st administration of ABL001 until the date of 1st documented progression, whichever came first, assessed up to 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 [ Time Frame: from date of 1st administration of ABL001 until the date of 1st documented progression, whichever came first, assessed up to 24 months ]
  Time interval from 1st administration of ABL001 to the time of disease progression, as determined by the investigator using RECIST 1.1 or discontinuation of ABL001 due to whatever reason, whichever comes first.
• Duration of response [ Time Frame: from date of 1st administration of ABL001 until the date of 1st documented progression, whichever came first, assessed up to 24 months ]
  Time interval from first occurrence of a documented objective response to the time of disease progression, as determined by the investigator using RECIST 1.1

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of CTX-009 (ABL001) in Combination With Irinotecan or Paclitaxel in Advanced or Metastatic Solid Tumor Patients
• Official Title: 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
• 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).

• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• P1b: Advanced Solid Tumors
• P2: Biliary Tract Cancer

Intervention

• Drug: CTX-009 (ABL001)
  CTX-009 (ABL001) will be administered biweekly.
• Drug: Paclitaxel
  Paclitaxel will be administered weekly.
• Drug: Irinotecan
  Irinotecan will be administered biweekly.

Study Arms

• Experimental: CTX-009 (ABL001) and Paclitaxel (P1b)
  Interventions:

  • Drug: CTX-009 (ABL001)
  • Drug: Paclitaxel
• Experimental: CTX-009 (ABL001) and Irinotecan (P1b)
  1 cycle = 4weeks
  Interventions:

  • Drug: CTX-009 (ABL001)
  • Drug: Irinotecan
• Experimental: CTX-009 (ABL001) and Paclitaxel (P2)
  1 cycle = 4weeks
  Interventions:

  • Drug: CTX-009 (ABL001)
  • Drug: Paclitaxel

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 6, 2021): 92
• Original Estimated Enrollment (submitted: July 29, 2020): 18
• Estimated Study Completion Date: July 31, 2025
• Actual Primary Completion Date: November 22, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT04492033
• Other Study ID Numbers: ABL001-P1bC; CTX-009-001 ( Other Identifier: Compass Therapeutics )
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Handok Inc.
• Original Responsible Party: ABL Bio, Inc.
• Current Study Sponsor: Handok Inc.
• Original Study Sponsor: ABL Bio, Inc.

Collaborators

• Compass Therapeutics
• ABL Bio, Inc.

• Investigators: Not Provided
• PRS Account: Handok Inc.
• Verification Date: December 2023