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

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ClinicalTrials.gov Identifier: NCT04492033
Recruitment Status : Recruiting
First Posted : July 30, 2020
Last Update Posted : June 30, 2022
Sponsor:
Collaborators:
Compass Therapeutics
ABL Bio, Inc.
Information provided by (Responsible Party):
Handok Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
P1b: Advanced Solid Tumors P2: Biliary Tract Cancer Drug: CTX-009 (ABL001) Drug: Paclitaxel Drug: Irinotecan Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 92 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : August 31, 2024
Estimated Study Completion Date : July 31, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. P2: Overall survival (OS) [ Time Frame: Up to approximately 24 months ]
    Time from the initiation of treatment to death


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04492033


Contacts
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Contact: SeungJi Yoo +82-2-527-5413 SeungJi.Yoo@handok.com
Contact: HyunJoo Son +82-2-527-5257 HyunJoo.Son@handok.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of
Contact: Jin Won Kim         
Contact: Keun-Wook Lee         
Asan Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Kyu-Pyo Kim         
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Joon Oh Park         
Contact: Jeeyun Lee         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Do-Yeon Oh (Coordinating Investigator)         
Sponsors and Collaborators
Handok Inc.
Compass Therapeutics
ABL Bio, Inc.
More Information
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Responsible Party: Handok Inc.
ClinicalTrials.gov Identifier: NCT04492033    
Other Study ID Numbers: ABL001-P1bC
CTX-009-001 ( Other Identifier: Compass Therapeutics )
First Posted: July 30, 2020    Key Record Dates
Last Update Posted: June 30, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Handok Inc.:
VEGF
DLL4
Solid Tumors
Bispecific antibody
anti-angiogenic
Additional relevant MeSH terms:
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Biliary Tract Neoplasms
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Biliary Tract Diseases
Digestive System Diseases
Paclitaxel
Irinotecan
Antineoplastic Agents, Phytogenic
 Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors