Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02559674
Other study ID # CA-ALT-803-01-15
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2016
Est. completion date February 21, 2018

Study information

Verified date January 2020
Source Altor BioScience
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 8
Est. completion date February 21, 2018
Est. primary completion date February 21, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

Inclusion Criteria:

- 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

- 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

Exclusion Criteria:

- 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

- 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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Gemcitabine
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-paclitaxel
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-803
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.

Locations

Country Name City State
United States University of Hawaii Cancer Center Honolulu Hawaii

Sponsors (1)

Lead Sponsor Collaborator
Altor BioScience

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determination of MTD; Phase Ib Determine the maximum tolerated dose (MTD) level and designate the recommended dose level for phase II. 9 Months
Primary 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
Primary Overall Survival; Phase II Determine the 8.5 month overall survival of treated patients 8.5 Months
Secondary Objective response rate Evaluate objective response rate in treated patients. 72 Months
Secondary Duration of response Evaluate duration of response in treated patients. 72 Months
Secondary Time to progression Evaluate time to progression in treated patients. 72 Months
Secondary Progression-free survival Evaluate progression-free survival in treated patients. 72 Months
Secondary 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-?), Tumor necrosis factor-alpha (TNF-a) and Monocyte chemoattractant protein-1 (MCP-1) 36 Months
Secondary Determine the level of anti-ALT-803 antibodies in patient serum Determine the level of anti-ALT-803 antibodies in patient serum 36 Months
Secondary 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) 36 Months
Secondary 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 36 Months
Secondary 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 36 Months
See also
  Status Clinical Trial Phase
Recruiting NCT05028933 - IMC001 for Clinical Research on Advanced Digestive System Malignancies Phase 1
Not yet recruiting NCT03662035 - Apatinib Combined With S-1 in the Second-line Treatment of Advanced Pancreatic Cancer Phase 2
Recruiting NCT05085548 - ProAgio in Previously Treated Advanced Pancreatic Cancer and Other Solid Tumor Malignancies Phase 1
Recruiting NCT06111274 - A Phase 2 Study of ABSK021 in Patients With Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT04137536 - A Study of Armed, Activated T-Cells in Patients With Advanced Pancreatic Cancer Phase 1
Completed NCT04617067 - Paricalcitol Trial: Phase II, Open Label Clinical Trial of Paricalcitol in Combination With Gemcitabine/ Nab-Paclitaxel Therapy in Advanced Pancreatic Cancer Phase 2
Active, not recruiting NCT04469556 - Pancreatic Adenocarcinoma Signature Stratification for Treatment Phase 2
Recruiting NCT04104672 - A Study to Evaluate the Safety and Tolerability of AB680 in Participants With Gastrointestinal Malignancies Phase 1
Not yet recruiting NCT05100329 - A Study of Mitoxantrone Hydrochloride Liposome Injection in Patients With Advanced Pancreatic Cancer Phase 2
Completed NCT02101580 - Ph 1B Trial With ADI-PEG 20 Plus Nab-Paclitaxel and Gemcitabine in Subjects With Pancreatic Cancer Phase 1
Not yet recruiting NCT06329947 - A Phase II Study of Surufatinib Combined With Camrelizumab and mFOLFOX6 as Second-line Treatment for Advanced PRAD Phase 2
Recruiting NCT02135822 - Nab-paclitaxel Plus Gemcitabine in Chinese Patients With Advanced Pancreatic Cancer Phase 2
Recruiting NCT04803851 - Anlotinib Plus Anti-PD-1 Antibody AK105 for Advanced Pancreatic Cancer Phase 1/Phase 2
Completed NCT03415802 - Efficacy and Safety of Nab-Paclitaxel Plus S-1 in the First-line Treatment of Advanced Pancreatic Cancer Phase 2
Recruiting NCT05162118 - Clinical Study of VG161 in Combination With Nivolumab in Subjects With Advanced Pancreatic Cancer Phase 1/Phase 2
Recruiting NCT04643405 - APG-1387 Plus Chemotherapy in Advanced Pancreatic Adenocarcinoma Phase 1/Phase 2
Recruiting NCT03889795 - Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors Phase 1
Completed NCT01303172 - A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer Phase 2
Not yet recruiting NCT06422156 - SBRT Combined With Nimotuzumab and Mono-chemotherapy in Locally Advanced Pancreatic Cancer Phase 2
Recruiting NCT04931381 - Organoid-Guided Chemotherapy for Advanced Pancreatic Cancer Phase 3