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Metastatic Pancreatic CancerPhase 1/2NCT05586516

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

A Phase 1/2 study testing IOA-289 in people with Metastatic Pancreatic Cancer, run by iOnctura at 3 sites in 2 countries.

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

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Pancreatic Cancer
What is being tested?
IOA-289
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
3 sitesin 2 countries
Study dates
10 Oct 2022to 18 Aug 2025
Phase
Phase 1/2
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

  • ≥18 years of age inclusive, at the time of signing the informed consent.
  • Capable of giving signed informed consent.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
  • Patients with histologically or cytologically confirmed metastatic unresectable pancreatic adenocarcinoma.
  • Have measurable disease (≥ 1 measurable lesion) based on Response Evaluation Criteria In Solid Tumours (RECIST) v1.1 as determined by the site study team.
  • Eligible to receive 1st line systemic treatment with gemcitabine/nab-paclitaxel for metastatic disease.
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  • Baseline CA19-9 levels are available from a sample acquired no more than 4 weeks prior to screening.
  • No prior systemic anti-cancer therapy for metastatic pancreatic cancer.
  • 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.

Who cannot join

  • Inability to swallow food or any condition of the upper gastrointestinal tract that precludes administration of oral medications.
  • Have prior significant medical history and AEs:
  • Known active CNS metastases and/or carcinomatous meningitis.
  • 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).
  • 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.
  • 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.
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  • Treatment with anticancer medications, investigational drugs, surgery and/or radiation within the following interval before the first administration of study drug:
  • < 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.
  • < 28 days for prior monoclonal antibody used for anticancer therapy with the exception of PD-1 pathway-targeted agents.
  • < 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.
  • 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.
  • Have received a live vaccine within 30 days of planned start of study therapy.
  • Have not recovered from toxic effect(s) of prior therapy to ≤ Grade 1, other than alopecia or fatigue.
  • Known allergy or reaction to any component of either study drug or formulation components.
  • Currently breastfeeding.
  • Known alcohol or other substance abuse.
  • Laboratory and medical history parameters not within Protocol-defined range. Absolute neutrophil count < 1.5 × 109/L.
  • Platelet count < 100 × 109/L.
  • Haemoglobin < 8 g/dL (transfusion is acceptable to meet this criterion).
  • 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.
  • 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.
  • 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)
  • International normalized ratio or prothrombin time (PT) > 1.5 × ULN.
  • Activated partial thromboplastin time (aPTT) > 1.5 × ULN.
  • 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.

Trial locations and contacts

3 sites in 2 countries.

3 sites in 2 countries

Italy2 sites

  • Medical Oncology and Immunotherapy Unit, University Hospital of Siena

    Siena, 53100

  • UO Oncologia of Azienda Ospedaliera Universitaria Integrata di Verona

    Verona, Verona, 37126

Other trials in Italy

United Kingdom1 site

  • Beatson West of Scotland Cancer Center

    Glasgow, G12 0YN

Other trials in United Kingdom

About this study

Official title: A Phase 1b, Open Label, Dose Escalation Study of IOA-289, an Orally Bioavailable, Selective Autotaxin (ENPP2) Inhibitor Alone and in Combination With Gemcitabine/Nab-paclitaxel 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.

Being tested
IOA-289
Keywords
Metastatic, Pancreatic, Cancer, Autotaxin, ATX, Lysophosphatidic acid, LPA, Fibrosis, Immune
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis, Neoplasms, Fibrosis

What participants receive

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

  • IOA-289Drug

    Also called gemcitabine, nab-paclitaxel, Abraxane

    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.

Study groups in NCT05586516
Study groupRoleWhat they receive
IOA-289 in combination with gemcitabine/nab-paclitaxelExperimentalNot described
Receives: Drug: IOA-289

What is being measured

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

  1. Incidence of treatment-emergent adverse events [Safety and Tolerability]

    Number of participants with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: Adverse event assessment will be assessed by CTCAE v5.0, through study completion, an average of 1 year.

Secondary outcomes (15)

  1. Cmax

    Peak plasma concentration

    Measured: at 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.

  2. Cmin

    Minimum observed plasma concentration

    Measured: at 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.

  3. t½

    Terminal elimination half-life

    Measured: at 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.

  4. tmax

    Time of the maximum observed plasma concentration

    Measured: at 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.

  5. AUC0-t

    Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration

    Measured: at 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.

  6. AUC0-∞

    Area under the plasma concentration-time curve from time zero extrapolated to infinity

    Measured: at 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.

  7. BED

    Define the biologically effective dose (BED) of IOA-289 based on available parameters

    Measured: for an average of 6 months

  8. CA19-9

    Assess changes of CA19-9 levels compared to baseline

    Measured: for an average of 6 months

  9. LPA

    Determine the PD activity of IOA-289, incl levels of LPA

    Measured: for an average of 6 months

  10. Preliminary efficacy

    Document 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)

    Measured: Imaging for RECIST assessment will start at C2D1 ±3 Days and repeated every 8 Weeks (56 ± 5Days) until disease progression.

  11. Overall response rate [ORR]

    ORR defined as percentage of patients with a CR or PR based on appropriate radiographic imaging and consistent with RECIST 1.1

    Measured: for an average of 6 months

  12. Disease control rate [DCR]

    DCR is defined as the combined percentage of patients with radiographic CR, PR and SD at different time points

    Measured: for an average of 6 months

  13. 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 response

    Measured: for an average of 6 months

  14. 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 assessment

    Measured: for an average of 6 months

  15. Overall survival [OS]

    OS defined as the time from the date of the first dose of study treatment until death from any cause.

    Measured: for an average of 6 months

Timeline

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

  1. First posted19 Oct 2022
  2. Study start10 Oct 2022
  3. Primary completion18 Aug 2025
  4. Study completion18 Aug 2025

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05586516
Sponsor's protocol ID
IOA-289-102
Status last verified
Mar 2026
First submitted
13 Oct 2022
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 37278638

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IOA-289 in people with Metastatic Pancreatic Cancer, run by iOnctura at 3 sites in 2 countries.

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 9 inclusion and 26 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy, United Kingdom. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of treatment-emergent adverse events [Safety and Tolerability] (time frame: Adverse event assessment will be assessed by CTCAE v5.0, through study completion, an average of 1 year.). 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 NCT05586516, which also lists 1 linked publication.

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 30 Mar 2026.

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