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Advanced Pancreatic CancerPhase 1NCT02559674

QUILT-2.001: ALT-803 in Patients With Advanced Pancreatic Cancer in Conjunction With Gemcitabine and Nab-Paclitaxel

A Phase 1 study testing Gemcitabine, Nab-paclitaxel and ALT-803 in people with Advanced Pancreatic Cancer, run by Altor BioScience at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Pancreatic Cancer
What is being tested?
Gemcitabine, Nab-paclitaxel and ALT-803
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jul 2016to 21 Feb 2018
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

  • 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
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  • 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
  • Total bilirubin ≤ 2.0 X ULN, or ≤ 3.0 X ULN (for patients with Gilbert's Syndrome)
  • aspartate aminotransferase, alanine aminotransferase ≤ 2.5 X ULN, or ≤ 5.0 X ULN (if liver metastasis present)
  • Normal clinical assessment of pulmonary function
  • Negative serum pregnancy test if female and of childbearing potential
  • Subjects, both females and males, with reproductive potential must agree to use effective contraceptive measures for the duration of the study
  • Must provide informed consent and HIPPA authorization and agree to comply with all protocol-specified procedures and follow-up evaluations

Who cannot join

  • 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
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  • 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
  • No known HIV-positive or AIDS unless patient is on a stable highly active antiretroviral therapy (HAART) regimen, have CD4 (cluster of differentiation 4) counts >350, with no detectable viral load on quantitative polymerase chain reaction test
  • No untreated central nervous system metastases, or if treated must be neurologically stable for at least 2 weeks prior to enrollment
  • No corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
  • No psychiatric illness/social situation that would limit compliance
  • No other illness that in the opinion of the investigator would exclude the subject from participating in the study
  • No active systemic infection requiring parenteral antibiotic therapy
  • No anti-cancer treatment including surgery, radiotherapy, chemotherapy, other immunotherapy, or investigational therapy within 14 days before treatment start
  • No disease requiring systemic immunosuppressive therapy
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 3 years after surgical treatment.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

Other trials in United States

About this study

Official title: Phase Ib/II Study of ALT-803 in Combination With Gemcitabine and Nab-paclitaxel in Patients With Advanced Pancreatic Cancer

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.

Read the detailed description

The purpose of this study is to evaluate the safety and tolerability of escalating doses, to identify the Maximum Tolerated Dose (MTD) and designate a dose level for Phase II study (RP2D) of ALT-803 administered in combination with gemcitabine and nab-paclitaxel in patients with advanced pancreatic cancer.

To access the anti-tumor activity of ALT-803 administered in combination with gemcitabine and nab-paclitaxel as measured by objective response rate, overall survival, progression-free survival, time to progression, and duration of response in patients with advanced pancreatic cancer.

To Characterize the pharmacokinetic, immunogenicity, and serum cytokine profile of ALT-803 in combination with gemcitabine and nab-paclitaxel in treated patients. To correlate circulating cell free DNA and circulating tumor DNA with clinical outcomes of the study in treated patients.

Being tested
Gemcitabine, Nab-paclitaxel, ALT-803
Keywords
Pancreas, Pancreatic, Cancer, Advanced Pancreatic Cancer, Immunotherapy, Immunotherapeutic, Interleukin-15, Gemcitabine, Nab-paclitaxel, Solid Tumor, Metastatic Disease, Combination Immunotherapy
Medical subject headings
Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GemcitabineBiological

    Also called Gemzar

    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.

  • Nab-paclitaxelBiological

    Also called Abraxane

    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.

  • 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.

Study groups in NCT02559674
Study groupRoleWhat they receive
Phase Ib/II ALT-803 w/ gemcitabine and nab-paclitaxelExperimentalNot described
Receives: Biological: Gemcitabine; Biological: Nab-paclitaxel; Biological: ALT-803

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Determination of MTD; Phase Ib

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

    Measured: 9 Months

  2. 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

    Measured: 48 Months

  3. Overall Survival; Phase II

    Determine the 8.5 month overall survival of treated patients

    Measured: 8.5 Months

Secondary outcomes (9)

  1. Objective response rate

    Evaluate objective response rate in treated patients.

    Measured: 72 Months

  2. Duration of response

    Evaluate duration of response in treated patients.

    Measured: 72 Months

  3. Time to progression

    Evaluate time to progression in treated patients.

    Measured: 72 Months

  4. Progression-free survival

    Evaluate progression-free survival in treated patients.

    Measured: 72 Months

  5. Biomarkers; Phase Ib

    Measure the serum levels of the following including but not limited to Interleukin-2 (IL-2), Interleukin-4 (IL-4), Interleukin-6 (IL-6), Interleukin-10 (IL-10), Interferon-gamma (IFN-ɣ), Tumor necrosis factor-alpha (TNF-α) and Monocyte chemoattractant protein-1 (MCP-1)

    Measured: 36 Months

  6. Determine the level of anti-ALT-803 antibodies in patient serum

    Determine the level of anti-ALT-803 antibodies in patient serum

    Measured: 36 Months

  7. Area under the plasma concentration-time curve from time zero to infinity (AUC); Phase Ib

    Area under the plasma concentration-time curve from time zero to infinity (AUC)

    Measured: 36 Months

  8. Correlation between the level of circulating cell free DNA in patient plasma and response to study treatment

    Correlation between the level of circulating cell free DNA in patient plasma and response to study treatment

    Measured: 36 Months

  9. Correlation between the level of tumor DNA in patient plasma and response to study treatment

    Correlation between the level of tumor DNA in patient plasma and response to study treatment

    Measured: 36 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2015 (estimated)
  2. Study startJul 2016
  3. Primary completion21 Feb 2018
  4. Study completion21 Feb 2018

Resources

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
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02559674
Sponsor's protocol ID
CA-ALT-803-01-15
Status last verified
Jan 2020
First submitted
23 Sep 2015
Last updated
27 Jan 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Gemcitabine, Nab-paclitaxel and ALT-803 in people with Advanced Pancreatic Cancer, run by Altor BioScience 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 21 inclusion and 24 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: finished, as of the sponsor's last update on 27 Jan 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Determination of MTD; Phase Ib (time frame: 9 Months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02559674.

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 27 Jan 2020.

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