Active — Not RecruitingPhase 1

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

Italy, United Kingdom210 participantsStarted 2020-02-25

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. ≥18 years of age inclusive, at the time of signing the informed consent.
✓. Capable of giving signed informed consent, which includes compliance with the requirements of this protocol.
✓. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. For patients with NHL, ECOG 2 will be allowed.
✓. Patients with histologically or cytologically confirmed advanced or metastatic malignancies (including histologically confirmed, unresectable Stage III or IV melanoma); see following details for each malignancy:
✓. Baseline lactate dehydrogenase levels are available.
✓. Disease progression is confirmed and they are eligible for second- or third-line treatment:
✓. No clinically significant tumour-related symptoms.
✓. Histological confirmation of mesothelioma (any subtype).

What they're measuring

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

Timeframe: From time of first drug administration to first documented progression, toxicity or death from any cause whichever occurs first, assessed at week 30

Trial details

NCT IDNCT04328844

SponsoriOnctura

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-13

View on ClinicalTrials.gov More Solid Tumor, Adult trials