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QUILT-3.014: A Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas | Clinical Trials | Clareo Health

WITHDRAWNPHASE1

QUILT-3.014: A Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas

A Phase I Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas

NCT02582827•NantBioScience, Inc.

View on ClinicalTrials.gov

Summary

The primary objective of study CA601.2 is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of ABI-011 when administered by intravenous (IV) infusion on Days 1, 8, and 15, followed by a week of rest, in patients with advanced solid tumor malignancies or lymphomas. The MTD will be determined using a standard 3+3 design. The secondary objectives are to evaluate the safety and toxicity profile, to evaluate the plasma pharmacokinetics (PK), to assess the biological activity and pharmacodynamics, and to make a preliminary assessment of tumor response in patients with advanced solid tumors or lymphomas. The exploratory objectives are to determine the genomic and proteomic profile of patients' tumors to identify gene mutations, gene amplifications, levels of protein expression, and pinpoint oncoproteins. Correlations between genomic/proteomic profiles and efficacy outcomes will be assessed and principal metabolites of ABI-011 will be determined, if possible. Approximately 45-60 patients will be treated to determine dose limiting toxicities (DLTs), the MTD, and/or RP2D of ABI-011. Once the RP2D is identified, expansion of this cohort (up to 10 patients) will occur.

Detailed Description

ABI-011 is a novel, albumin-bound formulation of a potent thiocolchicine analog, IDN 5404, with a mean particle size of approximately 100 nanometers (nm). The active drug, IDN 5404, is related to the colchicine family of tubulin-binding compounds that have been found to have vascular-disrupting activity in vivo. Studies are ongoing to determine whether IDN 5404 has vascular-disrupting activity. As a dimer, IDN 5404 has an additional activity as an inhibitor of topoisomerase I, a critical enzyme in deoxyribonucleic acid (DNA) repair mechanisms. Although the active compound has limited solubility, IDN 5404 formulated as ABI-011 is soluble in saline, facilitating IV dosing and delivery of the active agent to tumors and the tumor vasculature. The primary objective of study CA601.2 is to determine the MTD or RP2D of ABI-011 when administered by IV infusion on Days 1, 8, and 15, followed by a week of rest, in patients with advanced solid tumor malignancies or lymphomas. The MTD will be determined using a standard 3+3 design. The secondary objectives are to evaluate the safety and toxicity profile, to evaluate the plasma PK (elimination rate constant, elimination half-life, volume of distribution, maximum serum concentration (Cmax), time to maximum concentration (tmax), and area under the time-concentration curve to time infinity (AUCinf), to assess the biological activity and pharmacodynamics, and to make a preliminary assessment of tumor response in patients with advanced solid tumors or lymphomas. The exploratory objectives are to determine the genomic and proteomic profile of patients' tumors to identify gene mutations, gene amplifications, levels of protein expression, and pinpoint oncoproteins. Correlations between genomic/proteomic profiles and efficacy outcomes will be assessed and principal metabolites of ABI-011 will be determined, if possible. Approximately 45-60 patients will be treated to determine DLTs, the MTD, and/or RP2D of ABI-011. Once the RP2D is identified, expansion of this cohort (up to 10 patients) will occur. Patients with cytologically or histologically confirmed solid tumor malignancies or lymphoma for which no curative standard approved therapy is available with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 will be included. In the dose-escalation phase of the study, patients can have measurable or non-measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.1, criteria. In the dose-expansion phase of the study, only patients with measurable disease will be enrolled. No anti-cancer therapies (inclusive of investigational therapies) are allowed 5 half-lives/4 weeks (whichever is longer) prior to study drug administration (6 weeks for nitrosoureas or mitomycin C). ABI-011 will be administered via IV infusion for 30 minutes weekly on Days 1, 8, and 15 of a 28-Day cycle. The starting dose will be 2 mg/m2. Patients will be allowed to continue treatment until they experience progressive disease or unacceptable toxicity, withdraw consent, or their physician feels it is no longer in their best interest to continue on treatment.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Each patient must meet all of the following criteria to be enrolled in this study.
•1. Patients ≥ 18 years of age (male and female).
•2. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
•3. Patients must be willing and able to sign an informed consent.
•4. Cytologically or histologically confirmed solid tumor malignancy or lymphoma for which no curative standard approved therapy is available.
•5. Patient agrees and is willing to provide 1 serial tumor biopsy (biopsies are mandatory), which would not put the patient or their treatment at significant risk.
•6. During the dose-escalation phase, measurable or non-measurable disease as defined by RECIST criteria (Version 1.1); during the dose- expansion phase only; disease must be measurable by RECIST criteria (Version 1.1) (clinical or radiological).
•7. Life expectancy of ≥ 12 weeks in the opinion of the investigator and medical monitor.
•8. All adverse events (AEs) (except alopecia) of any prior chemotherapy, surgery, or radiotherapy must have resolved to Grade ≤ 1.
•9. The following laboratory results must be present within the 14 days prior to the first administration of ABI-011:
+12 more criteria

Exclusion Criteria

•Patients who meet any of the following criteria will be excluded from the study:
•1. Inability to comply with study and follow-up procedures.
•2. Women who are pregnant or breastfeeding (lactating).
•3. Treatment with chemotherapy, hormonal therapy for cancer treatment (except leuprolide for prostate cancer), immunotherapy, biologic therapy, or radiation therapy as cancer therapy within 4 weeks or 5 half-lives, whichever is longer. Six weeks should have elapsed if prior chemotherapy treatment included nitrosoureas or mitomycin C.
•4. Patients who have received antibody-based therapies within 28 days or 5 half-lives of the agent, whichever time period is longer.
•5. Major surgery within 6 weeks before the first administration of study drug; needle aspirations, bone marrow biopsy and other similar procedures are allowable; minor surgery may be allowable following discussion and approval by Medical Monitor.
•6. Prior treatment with tumor vascular disrupting agents (VDAs).
•7. Any uncontrolled medical or psychiatric risk factors that would contraindicate the use or impair the ability of the patient to receive therapy per protocol or that may impose excessive risk to the patient.
•8. Central nervous system (CNS) metastases. Patients who have a history of CNS metastases or who display signs or symptoms of CNS metastases should be imaged with magnetic resonance imaging (MRI) or computed tomography (CT) within 2 months of screening; if a patient has current symptoms, the MRI or CT should be performed at screening. Should active metastases be detected, these patients will not be enrolled. Patients with previously treated brain metastases will not be enrolled if taking steroids or anti-convulsants.
•9. History of vascular neuropathy.
+27 more criteria

Locations (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, United States

Key Dates

Start Date

November 13, 2017

Primary Completion Date

August 23, 2019

Completion Date

August 23, 2019

Last Updated

August 28, 2019

Conditions

Neoplastic Disease

Interventions

ABI-011

DRUG

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TERMINATEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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