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

Sponsor
iOnctura
Study ID
NCT04328844
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Myelofibrosis
  • NSCLC
  • Non-Hodgkin Lymphoma, Adult
  • Solid Tumor, Adult
  • Uveal Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IOA-244 — DRUG
    IOA-244 will be administered orally once daily (QD)
  • Avelumab Injection — DRUG
    Avelumab will be administered IV every 2 weeks
  • Pemetrexed — DRUG
    Pemetrexed will be administered IV every 3 weeks
  • Cisplatin — DRUG
    Cisplatin will be administered IV every 3 weeks
  • Ruxolitinib — DRUG
    Ruxolitinib will be administered orally twice a day (BD)

Study Details

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)

Key Dates

First listed
Mar 31, 2020
Start date
Feb 25, 2020
Status verified
Jul 2026
Primary completion
Dec 13, 2023
Completion
Mar 31, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: Cutaneous Melanoma
    IOA-244 in combination with avelumab
  • Experimental: Group 2: Uveal Melanoma
    IOA-244 as monotherapy
  • Experimental: Group 3: Myelofibrosis
    IOA-244 in combination with ruxolitinib
  • Experimental: Group 4: Mesothelioma
    IOA-244 in combination with pemetrexed/cisplatin/avelumab
  • Experimental: Group 5: NSCLC 1st line
    IOA-244 in combination with pemetrexed/cisplatin/avelumab
  • Experimental: Group 6: NSCLC 2nd/3rd line
    IOA-244 in combination with avelumab
  • Experimental: Group 7: NHL-FL and NHL-PTCL
    IOA-244 as monotherapy

Primary Outcome Measure

Numbers of participants with treatment-related adverse events as assessed by CTCAE v5.0 [ Time Frame: From time of first drug administration to first documented progression, toxicity or death from any cause whichever occurs first, assessed at week 30 ]

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