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About
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)
Enrollment
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Inclusion and exclusion criteria
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:
For Patients with cutaneous and mucosal melanoma:
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.
For Patients with metastatic ocular/uveal melanoma:
Patients must have metastatic histologically or cytologically confirmed uveal melanoma.
For Patients with advanced or metastatic mesothelioma:
Part B: Considered for first-line treatment with pemetrexed/cisplatin and avelumab.
For Patients with Indolent Non-Hodgkin Lymphoma, type Follicular Lymphoma (FL):
For Patients with Non-Hodgkin Lymphoma, type Peripheral T cell lymphoma (PTCL):
Diagnosis of one of the following histologic subtypes of PTCL, pathologically-confirmed, as defined by the World Health Organization (other rare PTCL may be enrolled upon discussion with the medical monitor of this study):
Received at least 2 cycles of one prior regimen administered with curative intent and one of the following:
For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin.
Measurable disease as defined by IWG for PTCL, i.e., at least 1 measurable disease lesion > 1.5 cm in at least one dimension by 18FDG-PET-CT, MRI, or diagnostic CT.
Patients with prior exposure to a PI3K inhibitor (e.g., idelalisib/GS-1101, duvelisib) or a Bruton's tyrosine kinase (BTK) inhibitor are eligible if they discontinued either inhibitors in the last 4 weeks prior entering study treatment.
For Patients with Non-Small Cell Lung Cancer (NSCLC) 1st line:
For Patients with Non-Small Cell Lung Cancer (NSCLC) 2nd or 3rd line:
Histological confirmed Stage IIIb/IV or recurrent NSCLC who have experienced disease progression.
Considered for 2nd line or 3rd line treatment either after radiographic progression or on stable disease:
For Patients with Primary Myelofibrosis (PMF):
Presence of measurable disease per RECIST v.1.1, or mRECIST (for cohort with pleural mesothelioma patients), as determined by the site study team. Tumour lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
For NHL (FL and PTCL) patients: Have measurable disease as defined by the Lugano Classification, including at least one lymph node or tumour mass greater than or equal to 1.5 cm.
For PMF patients: Have measurable disease as defined by IWG-MRT criteria.
For patients with prior systemic therapies (Groups 1, 2, 6, and 7) disease progression must be reported after available therapies for advanced or metastatic disease that are known to confer clinical benefit, been intolerant to treatment, or refused standard treatment. Within 6 months and prior to entering the study, a patient who has completed an adjuvant, neo-adjuvant, or chemo-radiation regimens would be considered of having received 1 prior systemic regimen and would not require an additional systemic regimen for advanced or metastatic disease.
Willingness to undergo a pre-treatment and on-treatment tumour biopsy to obtain the specimen (for NHL and PMF: see respective requirements).
Note: If a patient has signed the informed consent and is scheduled to have a tumour biopsy for the purposes of this study, and it is subsequently determined that tumour tissue cannot safely be obtained, the patient may still enrol in the study, and the patient may be replaced, if enrolled in Part A, after discussion between the Sponsor and Investigator. The patient will be replaced if enrolled in Part B. However, all patients will be part of the final safety PK, PD (except for the examinations related to the pre- and post-dosing biopsy) and efficacy evaluation.
Willingness to avoid pregnancy or fathering children based on the criteria below:
Primary purpose
Allocation
Interventional model
Masking
210 participants in 7 patient groups
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Central trial contact
Michael Lahn, MD
Data sourced from clinicaltrials.gov
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