This is a Study to Evaluate the Safety and Tolerability of the Study Drug ABL001, and to Determine the Maximum Tolerated Dose and/or Recommended Phase 2 Study Dose of ABL001

ABL Bio

Status and phase

Completed

Phase 1

Conditions

Advanced Solid Tumors

Treatments

Drug: NOV1501 (ABL001)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03292783

NOV150101-101

Details and patient eligibility

About

The purpose of this open-label, dose escalation-dose expansion, Phase 1 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 NOV1501 (ABL001).

Full description

This is an open-label, Phase 1 dose escalation and expansion study of NOV1501 (ABL001) to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and the anti-tumor efficacy of ABL001 in patients with advanced solid tumors after failure of standard of care.

Patients will be enrolled in two stages: a dose-escalation stage and an expansion phase. DLTs will be assessed as the primary endpoint in this trial.

Enrollment

45 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

≥19 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
Less than 4 weeks have elapsed since a major surgery and 2 weeks have elapsed since a minor surgery
New York Heart Association (NYHA) class ≥II congestive heart failure (CHF)
Persistent, clinically significant NCI-CTCAE v4.03 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
Peritoneal and/or pleural fluid drainage within 28 days prior to screening
History of hemoptysis within 28 days prior to screening
Serious, untreated scar, active ulcer, or untreated fracture