Neoplastic DiseasePhase 1NCT02582827
QUILT-3.014: A Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas
A Phase 1 study testing ABI-011 in people with Neoplastic Disease, run by NantBioScience, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplastic Disease
- What is being tested?
- ABI-011
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to 23 Aug 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- Potassium, ionized calcium, and magnesium within normal limits (WNL).
- Creatine kinase WNL.
- Serum creatinine ≤ 1.5 x ULN.
- Activated partial thromboplastin time (aPTT) and prothrombin time (PT), or International Normal Ratio (INR) WNL.
- WNL levels of troponin I.
- Women of child bearing potential and male patients who are not surgically sterile must be willing to practice contraceptive methods for the duration of the study and for 30-days following the last dose of study medication. Female patients must be postmenopausal (greater than 12 months from onset of menopause) or surgically sterile (have undergone bilateral oophorectomy or hysterectomy). Women of child bearing potential and women < 12 months since onset of menopause must agree to use an acceptable contraception method. If employing contraception, 2 of the following precautions must be used: vasectomy of partner, tubal ligation, vaginal diaphragm, intrauterine device, oral contraceptives (same oral contraceptive for a minimum of 3 months prior to screening), birth control injections, birth control implant, condom and spermicidal (gel/foam/cream/vaginal suppository). Male patients must be surgically sterile or agree to use a condom and acceptable contraception method with partner.
- Women of childbearing potential and women < 12 months since onset of menopause must have a negative serum pregnancy test (ß-hCG) within 24 hours prior to the first administration of study drug
Who cannot join
- 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.
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- 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.
- Known infection with human immunodeficiency virus (HIV) or known chronic active hepatitis B or hepatitis C virus (HBV/HCV) infection, unless a co-morbidity in patients with hepatocellular carcinoma (HCC).
- Inability to be venipunctured and/or tolerate venous access.
- Concurrent active second malignancy for which the patient is receiving therapy, excluding non-melanomatous skin cancer or carcinoma in situ of the cervix.
- Patients requiring therapeutic anticoagulation (e.g. warfarin, low-molecular weight heparin, or other anticoagulant) or with history of any bleeding diathesis. Aspirin or low-dose warfarin for catheter maintenance is allowed.
- Centrally-located lung tumors originating in the lungs and situated in the carinal bifurcation, the lung hila, or the main bronchi.
- Cardiovascular exclusion criteria:
- Left Ventricular Ejection Fraction (LVEF) < 50% as measured by echocardiography.
- History (within prior 24 months) of either myocardial infarction or unstable or poorly controlled angina.
- Electrocardiogram findings suggestive of significant current or previous ischemic heart disease, or left bundle branch block.
- A cumulative doxorubicin dose of 550 mg/m2 or more; if patient has had radiation to the chest and the heart was in the radiation field the maximum cumulative doxorubicin dose is 300 mg/m².
- Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification.
- Congenital or acquired long QT syndrome.
- Uncontrolled hypertension: Blood pressure (BP) which when assessed on two different occasions (e.g. screening and baseline) is greater than 150 millimeters of mercury (mmHg) systolic and 90 mmHg diastolic despite receipt of antihypertensive medication.
- Any current or past history of clinically significant arrhythmias, including treatment with anti-arrhythmics.
- QTc prolongation defined as a QTc interval according to Bazett's formula of ≥ 450 msec for male patients or ≥470 msec for female patients at Baseline. Interval determination will be based on a mean value obtained from 3 sequential baseline electrocardiographs (ECGs) obtained at least 5 minutes apart.
- History of symptomatic peripheral vascular disease (venous or arterial) requiring surgical intervention or chronic therapy (other than aspirin).
- Seizure disease requiring current anticonvulsant treatment.
- History of previous head trauma, cerebrovascular accident or transient ischemic attack within 24 months of enrollment.
- History of inflammatory bowel disease (active or past), or active peptic ulcer disease (prophylaxis with H2 blockers and proton pump inhibitors is acceptable).
- History of previous, whole abdomen radiation therapy or Grade ≥ 1 residual toxicity from previous radiation therapy.
- Administration of palliative radiotherapy for pain control within 7-days of planned administration of ABI-011.
- Transfusion of blood products [red blood cells (RBC), white blood cells (WBC) or whole blood] or Hematopoietic growth factors or other hematologic support, such as erythropoiesis-stimulating agents, granulocyte-colony stimulating factor (G-CSF), or platelet transfusion(s) within 14 days of screening.
- Participation in an investigational drug or device study within 30 days of screening for this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
Chan Soon-Shiong Institute for Medicine
El Segundo, California, 90245
About this study
Official title: A Phase I Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas
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.
Read the 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.
- Conditions
- Neoplastic Disease
- Being tested
- ABI-011
- Keywords
- Advanced Solid Tumors, solid tumor, lymphoma
- Medical subject headings
- Neoplasms, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI-011Drug
Also called IDN 5404 protein-bound particles for injectable suspension
ABI-011 is a novel, albumin-bound formulation of a potent thiocolchicine analog, IDN 5404, with a mean particle size of approximately 100 nm.
| Study group | Role | What they receive |
|---|---|---|
| ABI-011 | Experimental | IDN 5404 protein-bound particles for injectable suspension Receives: Drug: ABI-011 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine maximum tolerated dose (MTD) of ABI-011
Determine the maximum tolerated dose (MTD) for repeated dosing of ABI-011
Measured: 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
Evaluate safety and toxicity profile for repeated dosing of ABI-011. Number of subjects with adverse events (AEs), laboratory, electrocardiogram (ECG), echocardiogram, and ophthalmologic assessments, tumor pain and vital signs.
Measured: 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
Evaluate drug concentration time data by individual subject for repeated dosing of ABI-011.
Measured: 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
Evaluate drug concentration time data by individual subject for repeated dosing of ABI-011.
Measured: 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
Evaluate drug concentration time data by individual subject for repeated dosing of ABI-011.
Measured: 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)
Evaluate drug concentration time data by individual subject for repeated dosing of ABI-011.
Measured: Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)
Evaluate pharmacokinetics (PK) analysis; time to maximum concentration (tmax)
Evaluate drug concentration time data by individual subject for repeated dosing of ABI-011.
Measured: Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)
Evaluate pharmacokinetics (PK) analysis; area under the time-concentration curve (AUC)
Evaluate drug concentration time data by individual subject for repeated dosing of ABI-011.
Measured: Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)
Tumor response
Tumor response based on assessment of target and non-target lesions according to response evaluation criteria in solid tumors (RECIST) criteria.
Measured: Baseline and Every 8 weeks through Cycle 6, then every 12 weeks, approximately up to 2 years total
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2015 (estimated)
- Study start13 Nov 2017
- Primary completion23 Aug 2019
- Study completion23 Aug 2019
Why it stopped: Enrollment not initiated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplastic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NantBioScience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mira Kistler, MD, Principal investigator, Chan Soon-Shiong Institutes for Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02582827
- Sponsor's protocol ID
- QUILT-3.014
- Status last verified
- Sep 2018
- First submitted
- 14 Oct 2015
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Trial of ABI-011 Administered Weekly in Patients With Advanced Solid Tumors or Lymphomas
- ClinicalTrials.gov ID
- NCT02582827
- Acronym / sponsor ID
- QUILT-3.014
- Conditions
- Neoplastic Disease
- Keywords
- Advanced Solid Tumors, solid tumor, lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment not initiated
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NantBioScience, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 23 Aug 2019 (actual)
- Study completion
- 23 Aug 2019 (actual)
- First posted
- 21 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABI-011 | Experimental | Drug: ABI-011IDN 5404 protein-bound particles for injectable suspension |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (22 listed)
- 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.
Key exclusion criteria (38 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABI-011Also: IDN 5404 protein-bound particles for injectable suspensionABI-011 is a novel, albumin-bound formulation of a potent thiocolchicine analog, IDN 5404, with a mean particle size of approximately 100 nm. | Drug | ABI-011 |
Primary outcome
Determine maximum tolerated dose (MTD) of ABI-011
Time frame: During Cycle 1 and each 28-Day treatment cycle, End of Study, Follow-up, approximately up to 1 year
Determine the maximum tolerated dose (MTD) for repeated dosing of ABI-011
8 secondary outcomes
Evaluate safety and toxicity profile of ABI-011
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)
Evaluate pharmacokinetics (PK) analysis; time to maximum concentration (tmax)
Time frame: Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)
Evaluate pharmacokinetics (PK) analysis; area under the time-concentration curve (AUC)
Time frame: Cycle 1 (Days 1,2,3); Cycle 2 (Days 1, 2, 3); Cycle 3 (Days 1, 2, 3)
Tumor response
Time frame: Baseline and Every 8 weeks through Cycle 6, then every 12 weeks, approximately up to 2 years total
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mira Kistler, MD principal investigator
Chan Soon-Shiong Institutes for Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ABI-011 in people with Neoplastic Disease, run by NantBioScience, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine maximum tolerated dose (MTD) of ABI-011 (time frame: During Cycle 1 and each 28-Day treatment cycle, End of Study, Follow-up, approximately up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.