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A Study to Assess an ATX Inhibitor (IOA-289) in Patients with Metastatic Pancreatic Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1/PHASE2

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

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

NCT05586516•iOnctura

View on ClinicalTrials.gov

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. Blood and tumour samples for PK and PD will be collected and assessments for determination of any clinical efficacy will be completed.

Eligibility

Age

18 - No limit years

Sex

ALL

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.
+16 more criteria

Locations (3)

UO Oncologia of Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Verona, Italy

Medical Oncology and Immunotherapy Unit, University Hospital of Siena

Siena, Italy

Beatson West of Scotland Cancer Center

Glasgow, United Kingdom

Key Dates

Start Date

October 10, 2022

Primary Completion Date

December 1, 2025

Completion Date

March 1, 2026

Last Updated

March 20, 2025

Enrollment

ESTIMATED participants

Conditions

Metastatic Pancreatic Cancer

Interventions

IOA-289

DRUG

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

NCT07409272

Pancreatic CancerMetastatic Pancreatic Cancer+1 more

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RECRUITINGPHASE2

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

NCT05065801

Metastatic Pancreatic Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Effectiveness and Safety of Setidegrasib, Given With Either mFOLFIRINOX or NALIRIFOX Chemotherapies, in People With Pancreatic Cancer

Efficacy of Gembrax Followed by Folfirinox Versus Folfirinox Alone in First Metastatic Line Pancreatic Cancer Patients

Nab-Paclitaxel + Cisplatin + Gemcitabine + TTF in pt. w/ Metastatic PAC

Nal-IRI/5-FU/LV Chemotherapy Combined With PD-L1 Inhibitor and Multi-target Anti-angiogenic Small Molecule±SBRT as Second-line Therapy in Metastatic Pancreatic Cancer Patients

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

Irinotecan Hydrochloride Liposome Injection (II)in Combination With Oxaliplatin, 5-FU/LV Versus AG for First-line Treatment of Metastatic Pancreatic Cancer