NCT02559674

Brief Summary

This is a Phase Ib/II, open-label, multi-center, competitive enrollment and dose escalation study of ALT-803 in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer in conjunction with gemcitabine and nab-paclitaxel.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 23, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 24, 2015

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2018

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

September 23, 2015

Last Update Submit

January 24, 2020

Conditions

Advanced Pancreatic Cancer

Keywords

PancreasPancreaticCancerAdvanced Pancreatic CancerImmunotherapyImmunotherapeuticInterleukin-15GemcitabineNab-paclitaxelSolid TumorMetastatic DiseaseCombination Immunotherapy

Outcome Measures

Primary Outcomes (3)

  • Determination of MTD; Phase Ib

    Determine the maximum tolerated dose (MTD) level and designate the recommended dose level for phase II.

    9 Months

  • Safety Profile (Number and severity of treatment related AEs); Phase Ib and II

    Number and severity of treatment related adverse events (AEs) that occur or worsen after the first dose of study treatment

    48 Months

  • Overall Survival; Phase II

    Determine the 8.5 month overall survival of treated patients

    8.5 Months

Secondary Outcomes (9)

  • Objective response rate

    72 Months

  • Duration of response

    72 Months

  • Time to progression

    72 Months

  • Progression-free survival

    72 Months

  • Biomarkers; Phase Ib

    36 Months

  • +4 more secondary outcomes

Study Arms (1)

Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxel

EXPERIMENTAL
Biological: GemcitabineBiological: Nab-paclitaxelBiological: ALT-803

Interventions

GemcitabineBIOLOGICAL

Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of gemcitabine given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.

Also known as: Gemzar
Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxel
Nab-paclitaxelBIOLOGICAL

Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of nab-paclitaxel given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.

Also known as: Abraxane
Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxel
ALT-803BIOLOGICAL

Subcutaneous Injection; Patients will receive two 4-week cycles consisting of ALT-803 given on Day 2, 9, 16, 30, 37, and 44. Eligible patients may receive up to 10 additional treatment cycles.

Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically or cytologically confirmed diagnosis of pancreatic cancer.
  • For dose escalation phase (Phase Ib) distant metastatic disease or unresectable disease and not a candidate for down staging to resection.
  • For expansion phase (Phase II) distant metastatic disease only.
  • For dose escalation phase (Phase Ib) 0 or 1 prior lines of chemotherapy for advanced pancreatic cancer. Prior gemcitabine is allowed, however prior nab-paclitaxel is not allowed.
  • For expansion phase (Phase II) no prior therapy for pancreatic cancer is allowed except for adjuvant therapy as long as it was completed ≥ 6 months prior to study treatment start
  • Have at least one untreated and progressing tumor lesion that can be accurately measured according to Response Evaluation Criteria in Solid Tumor
  • Prior radiation is allowed if the index lesion(s) remains outside of the treatment field or has progressed since prior treatment. Radiation therapy must have been completed at least 4 weeks prior to the baseline scan
  • Resolved acute effects of any prior therapy to baseline or Grade ≤1
  • The Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1 or 2
  • Life expectancy ≥12 weeks
  • Glomerular Filtration Rate (GFR) \> 40mL (milliliter)/min; Creatinine ≤ 1.5 x ULN (Upper limit of Normal)
  • Platelets ≥100,000/uL (microliter)
  • Hemoglobin ≥ 9g/dL
  • Absolute Lymphocytes ≥800/uL
  • Absolute neutrophil count/absolute granulocyte count ≥1500/uL
  • +6 more criteria

You may not qualify if:

  • No women who are pregnant or nursing
  • No known hypersensitivity to gemcitabine or nab-paclitaxel
  • No concurrent herbal or unconventional therapy
  • No prior therapy with IL-15 or IL-15 analog
  • No ongoing toxicity from prior anti-cancer treatment that may interfere with study treatment. All toxicities attributed to prior anti-cancer therapy other than alopecia and fatigue must resolve to grade 1 or baseline before administration of the study treatment.
  • No positive Hep C serology or active Hep B infection
  • No congestive heart failure \< 6 months
  • No unstable angina pectoris \< 6 months
  • No myocardial infarction \< 6 months
  • No history of ventricular arrhythmias or severe cardiac dysfunction
  • No history of uncontrollable supraventricular arrhythmias
  • No New York Heart Association Class \> II congestive heart failure
  • No marked baseline prolongation of QT/QTc interval
  • No known autoimmune disease requiring active treatment. Subjects with a condition requiring systemic treatment with either corticosteroids (\>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of enrollment. Inhaled or topical steroids, and adrenal replacement steroid doses ≤ 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease
  • No known prior organ allograft or allogeneic transplantation
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

MeSH Terms

Conditions

NeoplasmsNeoplasm Metastasis

Interventions

Gemcitabine130-nm albumin-bound paclitaxelAlbumin-Bound PaclitaxelALT-803

Condition Hierarchy (Ancestors)

Neoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Hing C. Wong, Ph.D.

    Altor BioScience

    STUDY CHAIR

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

September 23, 2015

First Posted

September 24, 2015

Study Start

July 1, 2016

Primary Completion

February 21, 2018

Study Completion

February 21, 2018

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)