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A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers

NCT04328844 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 210

Last updated 2026-03-30

No results posted yet for this study

Summary

The objective of study IOA-244-101 is to determine whether IOA-244 is safe and tolerable in cancer patients (Part A). In addition, the study will assess whether IOA-244 can increase the anti-tumour immune response in patients both as monotherapy and in combination pemetrexed/cisplatin/avelumab (Part B Mesothelioma and NSCLC 1st line), in combination with avelumab (Part B Cutaneous Melanoma and NSCLC 2nd/3rd line) and ruxolitinib (Part B Primary Myelofibrosis)

Conditions

Interventions

DRUG

IOA-244

IOA-244 will be administered orally once daily (QD)

DRUG

Avelumab Injection

Avelumab will be administered IV every 2 weeks

DRUG

Pemetrexed

Pemetrexed will be administered IV every 3 weeks

DRUG

Cisplatin

Cisplatin will be administered IV every 3 weeks

DRUG

Ruxolitinib

Ruxolitinib will be administered orally twice a day (BD)

Sponsors & Collaborators

  • iOnctura

    lead INDUSTRY

Principal Investigators

  • Michael Lahn · iOnctura

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-25
Primary Completion
2023-12-13
Completion
2027-03-31

Countries

  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04328844 on ClinicalTrials.gov