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

NCT02582827 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: QUILT-3.014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neoplastic Disease

Keywords

Advanced Solid Tumors; solid tumor; lymphoma

Outcome Measures

Primary Outcomes (1)

• Determine maximum tolerated dose (MTD) of ABI-011

  Determine the maximum tolerated dose (MTD) for repeated dosing of ABI-011

  During Cycle 1 and each 28-Day treatment cycle, End of Study, Follow-up, approximately up to 1 year

Secondary Outcomes (8)

• Evaluate safety and toxicity profile of ABI-011

  During Cycle 1 and each 28-Day treatment cycle, End of Study, Follow-up, approximately up to 2 years total

• Evaluate pharmacokinetics (PK) analysis; elimination rate constant

  Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)

• Evaluate pharmacokinetics (PK) analysis; elimination half-life

  Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)

• Evaluate pharmacokinetics (PK) analysis; volume of distribution

  Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)

• Evaluate pharmacokinetics (PK) analysis; maximum plasma drug concentration (Cmax)

  Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)

Study Arms (1)

ABI-011

EXPERIMENTAL

IDN 5404 protein-bound particles for injectable suspension

Drug: ABI-011

Interventions

ABI-011 DRUG

ABI-011 is a novel, albumin-bound formulation of a potent thiocolchicine analog, IDN 5404, with a mean particle size of approximately 100 nm.

Also known as: IDN 5404 protein-bound particles for injectable suspension

ABI-011

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each patient must meet all of the following criteria to be enrolled in this study.
• Patients ≥ 18 years of age (male and female).
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Patients must be willing and able to sign an informed consent.
• Cytologically or histologically confirmed solid tumor malignancy or lymphoma for which no curative standard approved therapy is available.
• 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.
• 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).
• Life expectancy of ≥ 12 weeks in the opinion of the investigator and medical monitor.
• All adverse events (AEs) (except alopecia) of any prior chemotherapy, surgery, or radiotherapy must have resolved to Grade ≤ 1.
• The following laboratory results must be present within the 14 days prior to the first administration of ABI-011:
• Hemoglobin ≥ 9 g/dL.
• Absolute neutrophil count (ANC) ≥1.5 x 109/L.
• Platelet count ≥ 100 x 109/L.
• Serum bilirubin ≤ 1.5 x upper limit of normal (ULN).
• Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 2.5 ULN (except if liver metastases are present, then values must be ≤ 5 x ULN).

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Inability to comply with study and follow-up procedures.
• Women who are pregnant or breastfeeding (lactating).
• 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.
• Patients who have received antibody-based therapies within 28 days or 5 half-lives of the agent, whichever time period is longer.
• 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.
• Prior treatment with tumor vascular disrupting agents (VDAs).
• 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.
• 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.
• History of vascular neuropathy.
• History of vasculitides (autoimmune or idiopathic).
• History of retinopathy, including diabetic retinopathy. All patients must be evaluated by an ophthalmologist prior to study treatment.
• Current use of medications that may cause corrected QT interval (QTc) prolongation. If the need to use these medications arises during the study, a discussion with and approval by the Medical Monitor is required.
• History of allergy or hypersensitivity to any of the constituents of the ABI-011 formulation.
• Active uncontrolled bacterial, viral, or fungal infection, requiring systemic therapy.

Sponsors & Collaborators

• NantBioScience, Inc.: lead

Study Sites (1)

Chan Soon-Shiong Institute for Medicine

El Segundo, California, 90245, United States

Location

MeSH Terms

Conditions

Neoplasms; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mira Kistler, MD

  Chan Soon-Shiong Institutes for Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2015
• First Posted: October 21, 2015
• Study Start: November 13, 2017
• Primary Completion: August 23, 2019
• Study Completion: August 23, 2019
• Last Updated: August 28, 2019

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)