A PHASE 1/2 STUDY OF ONCOBAX®-AK ADMINISTERED IN COMBINATION WITH IMMUNOTHERAPY TO PATIENTS WITH ADVANCED SOLID TUMORS

Trial details

Who runs it

Everimmune

Trial code

EU 2024-516711-24-00

Record updated

2025. július 10.

Original description

Phase 1: Characterize the safety profile and tolerability of repeated doses of Oncobax®-AK, administered in combination with PD-L1-based chemo-immunotherapy in metastatic RCC patients deficient in Akkermansia Phase 2: Characterize the efficacy of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients and deficient in AkkermansiaRead full original descriptionShow less

Phase 1: Characterize the safety profile and tolerability of repeated doses of Oncobax®-AK, administered in combination with PD-L1-based chemo-immunotherapy in metastatic RCC patients deficient in Akkermansia Phase 2: Characterize the efficacy of repeated doses of Oncobax®-AK administered in combination with PD-L1-based immunotherapy in metastatic NSCLC or RCC patients and deficient in Akkermansia

Inclusion: Histologically or cytologically confirmed Stage IV NSCLC (for Phase 2 only) or clear cell RCC; Hemoglobin ≥90 g/L; Neutrophil count ≥1.0 x 10^9/L; Platelet count ≥75 x 10^9/L; Lymphocyte count > 0.5 x 10e^9/L; Albumin >30 g/L; A wash-out period of 5 half-lives or more since the last dose administered of any investigational medicinal products or chemotherapy received previously; For patients of child-bearing potential, commitment to use a birth control method with a failure rate of less than 1% per year, during the entire treatment period AND for at least 4 months after the last dose of ICI (for NSCLC patients, for Phase 2 only) OR at least 5 months after the last dose of nivolumab (for RCC patients); Signed informed consent form; Patient eligible for SOC PD-L1 based immunotherapy or chemo-immunotherapy (for NSCLC, for Phase 2 only) and ipilimumab + nivolumab (for RCC)); NSCLC cohort-specific criterion (for Phase 2 only): best tumor response (by iRECIST) as stable disease (SD) between 12 and 18 weeks after initiation of first line PD-L1-based immunotherapy or chemo-immunotherapy; RCC cohort-specific criterion: intermediate- or poor-risk newly diagnosed RCC patients (clear cell histology); Negative stool polymerase chain reaction (PCR) test for Akkermansia (A. muciniphila and A. massiliensis) as defined in paragraph 11.2.7.2. of the protocol; NSCLC cohort-specific criterion (for Phase 2 only): PD-L1 expression data ≥ 1%; At least one measurable (target) lesion per iRECIST; Eastern Cooperative Oncology Group (ECOG) performance status = 0-1; Age >18 years.

Exclusion: Immunosuppressive therapy (>10 mg prednisone/day equivalent) within 4 weeks of signed informed consent; Radiotherapy (>30 Gy) to the lung(s) within 6 months of signed informed consent; Active inflammatory bowel disease and/or any medical condition that alters the integrity of the intestinal barrier; Auto-immune diseases requiring systemic therapy; Known allergy to Oncobax®-AK excipients; Active infection. A 4-week delay must have elapsed between the resolution of any systemic infection and the initiation of Oncobax®-AK administration; Alanine aminotransferase (ALT) >5 times the upper limit of normal range (ULN); Calculated creatinine clearance <40 mL/min; Symptomatic brain metastases. Patients with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period; Pregnancy or breast-feeding; Other co-morbidities that, in the opinion of the Investigator, may place the patient at a higher risk of treatment-related AEs; Inability to comply with protocol-specific assessments; Patient is subject to any of the following procedures: ward of court, trusteeship, supervision order, applied mandate of future protection; Vaccination with a live attenuated virus, other than influenza, within 6 months of signed informed consent.

EU CTIS 2024-516711-24-00