$0.00
Shopping Cart
Facebook-f Instagram
DONATE
Donate

Clinical Trial Record

Return to Clinical Trials

A Study to Assess an ATX Inhibitor (IOA-289) in Patients with Metastatic Pancreatic Cancer

2022-10-10

2025-12-01

2026-03-01

24

Study Overview

A Study to Assess an ATX Inhibitor (IOA-289) in Patients with Metastatic Pancreatic Cancer

The objective of study IOA-289-102 is to evaluate the safety and tolerability of escalating doses of IOA-289 in patients with metastatic pancreatic cancer in combination with standard chemotherapy consisting of gemcitabine and nab-paclitaxel. Blood and tumour samples for PK and PD will be collected and assessments for determination of any clinical efficacy will be completed.

N/A

  • Metastatic Pancreatic Cancer
  • DRUG: IOA-289
  • IOA-289-102

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2022-10-13  

N/A  

2025-03-17  

2022-10-17  

N/A  

2025-03-20  

2022-10-19  

N/A  

2025-03  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: IOA-289 in combination with gemcitabine/nab-paclitaxel

DRUG: IOA-289

  • IOA-289 will be administered orally twice daily (BID), starting from C0D1. Gemcitabine and nab-paclitaxel will be administrated by IV infusion, weekly for 3 weeks of a 4 week cycle starting at C1D1.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Incidence of treatment-emergent adverse events [Safety and Tolerability]Number of participants with treatment-related adverse events as assessed by CTCAE v5.0Adverse event assessment will be assessed by CTCAE v5.0, through study completion, an average of 1 year.
Secondary Outcome MeasuresMeasure DescriptionTime Frame
CmaxPeak plasma concentrationat Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.
CminMinimum observed plasma concentrationat Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.
t½Terminal elimination half-lifeat Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.
tmaxTime of the maximum observed plasma concentrationat Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.
AUC0-tArea under the plasma concentration-time curve from time zero to the time of the last quantifiable concentrationat Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.
AUC0-∞Area under the plasma concentration-time curve from time zero extrapolated to infinityat Cycle 0 Day 1 (pre-dose and 1/2/3-4/6-8hrs post-dose), and predose for Cycle 0 Day 7, Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15 and from Cycle 2 onwards Day 1 and End of Treatment. Cycle 0 is 7 days and Cycle 1 and onwards is 28 days.
BEDDefine the biologically effective dose (BED) of IOA-289 based on available parametersfor an average of 6 months
CA19-9Assess changes of CA19-9 levels compared to baselinefor an average of 6 months
LPADetermine the PD activity of IOA-289, incl levels of LPAfor an average of 6 months
Preliminary efficacyDocument preliminary signs of clinical efficacy of IOA-289 when given in combination with gemcitabine/nab-paclitaxel (e.g. overall response rate [ORR], duration of response [DOR], disease control rate (DCR), progression-free survival [PFS], and overall survival [OS] using RECIST v1.1)Imaging for RECIST assessment will start at C2D1 ±3 Days and repeated every 8 Weeks (56 ± 5Days) until disease progression.
Overall response rate [ORR]ORR defined as percentage of patients with a CR or PR based on appropriate radiographic imaging and consistent with RECIST 1.1for an average of 6 months
Disease control rate [DCR]DCR is defined as the combined percentage of patients with radiographic CR, PR and SD at different time pointsfor an average of 6 months
Duration of response [DOR]DOR defined as time from first documented evidence of CR or PR until disease progression or death from any cause among patients who achieve objective responsefor an average of 6 months
Progression free survival [PFS]PFS defined as the time from the date of the first dose of study treatment until the earliest date of disease progression as determined by radiographic disease assessmentfor an average of 6 months
Overall survival [OS]OS defined as the time from the date of the first dose of study treatment until death from any cause.for an average of 6 months

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    Inclusion Criteria:
    1. ≥18 years of age inclusive, at the time of signing the informed consent. 2. Capable of giving signed informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 4. Patients with histologically or cytologically confirmed metastatic unresectable pancreatic adenocarcinoma. 5. Have measurable disease (≥ 1 measurable lesion) based on Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 as determined by the site study team. 6. Eligible to receive 1st line systemic treatment with gemcitabine/nab-paclitaxel for metastatic disease. 7. Baseline CA19-9 levels are available from a sample acquired no more than 4 weeks prior to screening. 8. No prior systemic anti-cancer therapy for metastatic pancreatic cancer. 9. Male subjects with female partners of childbearing potential, and female subjects of child-bearing potential who had a negative serum pregnancy test at screening, must agree to use a highly effective form of contraception (with at least 99% certainty) or avoid intercourse during and upon completion of the study and for at least 3 months after the last dose of study drug.
    Exclusion Criteria:
    1. Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications. 2. Have prior significant medical history and AEs:
    1. Known active CNS metastases and/or carcinomatous meningitis. 2. History or presence of an abnormal ECG that, in the Investigator's opinion, is clinically meaningful. Screening QTc interval > 480 milliseconds is excluded (corrected by Fridericia). 3. Known additional malignancy that is progressing or requires active treatment. Patients with active malignancy requiring concurrent intervention or previous malignancies (for example non-melanoma skin cancers, and in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma or breast) unless a complete remission was achieved at least 2 years prior to study entry and no additional therapy is required during the study period. 4. Any serious or uncontrolled medical disorder or active infection that, in the opinion of the Investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the patient to receive protocol therapy. 3. Treatment with anticancer medications, investigational drugs, surgery and/or radiation within the following interval before the first administration of study drug:
    1. < 14 days for chemotherapy, targeted small-molecule therapy, surgical resection of lesions or radiation therapy (prior palliative radiotherapy must have been completed at least 14 days prior to study drug administration). A 1-week washout is permitted for palliative radiation to non-CNS disease with Sponsor approval.
    Note: The use of denosumab against osteoporosis is permitted. 2. < 28 days for prior monoclonal antibody used for anticancer therapy with the exception of PD-1 pathway-targeted agents. 3. < 28 days or 5 half-lives (whichever is longer) before the first dose for all other investigational study drugs or devices. For investigational agents with long half-lives (e.g., > 5 days), enrolment before the fifth half-life requires Medical Monitor approval. 4. Receiving an immune-suppressive based treatment for any reason (including chronic use of systemic corticosteroid at doses > 10 mg/day prednisone equivalent) within 14 days prior to the first dose of study treatment (see the exception for CNS lesions described in 2a). Use of inhaled or topical steroids or brief corticosteroid use for radiographic procedures or systemic corticosteroids ≤ 10 mg is permitted. 5. Have received a live vaccine within 30 days of planned start of study therapy. 6. Have not recovered from toxic effect(s) of prior therapy to ≤ Grade 1, other than alopecia or fatigue. 7. Known allergy or reaction to any component of either study drug or formulation components. 8. Currently breastfeeding. 9. Known alcohol or other substance abuse. 10. Laboratory and medical history parameters not within Protocol-defined range. Absolute neutrophil count < 1.5 × 109/L.
    1. Platelet count < 100 × 109/L. 2. Haemoglobin < 8 g/dL (transfusion is acceptable to meet this criterion). 3. Serum creatinine ≥ 1.5 × institutional ULN or measured or calculated creatinine clearance (glomerular filtration rate can also be used in place of creatinine or CrCl) < 50 mL/min for patients with creatinine levels > 1.5 × institutional ULN. 4. Aspartate aminotransferase, ALT, and alkaline phosphatase (ALP) ≥ 2.5 × ULN. Note: Patients with 1) bone metastases and 2) no hepatic parenchymal metastases on screening radiographic examinations may enrol if the ALP is < 5 × ULN. Patients with 1) bone metastases and 2) hepatic parenchymal metastases on screening radiographic examinations may enrol if the ALP is < 5 × ULN only with Medical Monitor approval. 5. Total bilirubin ≥ 1.5 × ULN are excluded unless direct bilirubin is ≤ ULN. If there is no institutional ULN, then direct bilirubin must be < 40% of total bilirubin to be eligible (except patients with Gilbert syndrome - see Note below) 6. International normalized ratio or prothrombin time (PT) > 1.5 × ULN. 7. Activated partial thromboplastin time (aPTT) > 1.5 × ULN. 8. Evidence of acute infection of hepatitis B virus (HBV), hepatitis C virus (HCV) and HIV. Patients who are on stable antiviral therapy and/or asymptomatic are eligible for the study.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Khasabova IA, Khasabov SG, Johns M, Juliette J, Zheng A, Morgan H, Flippen A, Allen K, Golovko MY, Golovko SA, Zhang W, Marti J, Cain D, Seybold VS, Simone DA. Exosome-associated lysophosphatidic acid signaling contributes to cancer pain. Pain. 2023 Dec 1;164(12):2684-2695. doi: 10.1097/j.pain.0000000000002967. Epub 2023 Jun 6.
NPCF Pop up

Make-A-Will Month

Snag 6508be92
Learn More
Donate Now Online
Other Ways to Donate