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

  • STATUS
    Recruiting
  • End date
    Jul 31, 2025
  • participants needed
    92
  • sponsor
    Handok Inc.
Updated on 12 July 2022

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.

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).

Details
Condition P1b: Advanced Solid Tumors, P2: Biliary Tract Cancer
Treatment Paclitaxel, Irinotecan, ABL001, Paclitaxel+ ABL001, Irinotecan+ ABL001, CTX-009 (ABL001)
Clinical Study IdentifierNCT04492033
SponsorHandok Inc.
Last Modified on12 July 2022

Eligibility

Yes No Not Sure

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
Women of childbearing potential must have a negative pregnancy test outcome
At least one lesion measurable defined by response evaluation criteria in solid tumors (RECIST) version 1.1
Life expectancy ≥ 12 weeks
Patients must provide written informed consent to voluntary participation in this study
ECOG performance status 0 or 1

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
Symptomatic or uncontrolled central nervous system (CNS) metastasis
Persistent, clinically significant NCI-CTCAE v5.0 Grade ≥ 2 toxicities from the previous anticancer therapy
Pregnant or lactating women or patients planning to become pregnant during the study
Severe infections or major and unhealed injury (active ulcer, untreated fracture)
Administration of antiplatelets or anticoagulants within 2 weeks prior to screening
Requiring continuous treatment with systemic NSAIDs or systemic corticosteroids
Participation in another clinical trial within 30 days prior to initiation of study treatment and received an investigational drug treatment
HIV or other severe diseases that warrant the exclusion from this study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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