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

Start date
Feb 25, 2020
Status verified
Mar 2026
Primary completion
Dec 13, 2023
Completion
Mar 31, 2027

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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