This is a Study to Evaluate the Safety and Tolerability of the Study Medication ABL001 in Combiation With Irinotecan/Paclitaxel and to Determine the Maximum Tolerated Dose and/or Recommended Phase 2 Study Dose of ABL001 in Combination With Irinotecan/Paclitaxel.

  • STATUS
    Recruiting
  • participants needed
    18
  • sponsor
    ABL Bio, Inc.
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Updated on 5 August 2020
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Summary

The purpose of this open-label, combination dose escalation, Phase 1b/2a clinical trial is to evaluate the safety, pharmacokinetics and anti-tumor activity and determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of combination therapy with ABL001(NOV1501) and Paclitaxel/Irinotecan .

Details
Condition Advanced Solid Tumors
Age 19years - 100years
Treatment Paclitaxel+ ABL001, Irinotecan+ ABL001
Clinical Study IdentifierNCT04492033
SponsorABL Bio, Inc.
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

year old patients with histologically or cytologically confirmed metastatic or unresectable advanced solid tumors
Lesions measured by tumor markers or by CT/MRI must be evaluable based on response evaluation criteria in solid tumors (RECIST) version 1.1
Life expectancy 12 weeks
ECOG performance status 2
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 major surgery and 2 weeks have elapsed since a minor 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 severe traumatic systemic disorders
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 screening
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
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