Safety, Pharmacokinetics (PK), and Efficacy of ONC 841 in Advanced Solid Tumors
ConditionAdvanced Solid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncoC4, Inc.
About this trial
This is a Phase I/II open label study of intravenous (IV) infusion of ONC-841 as a single agent or in combination in patients with advanced/metastatic solid tumors. The study will evaluate seven dose levels of ONC-841. The Phase 1 part is dose escalation with 7 dose levels of ONC-841 and the dose expansion in the last dose level. The Phase 2 part will test the combination of ONC-841 with SOC in GBM and in CRC.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Must have ECOG score ≤ 1. The body weight should be ≥40 kg.
A histological or cytological diagnosis of solid tumors and metastatic disease or locally advanced disease.
Must have measurable target lesion according to RECIST V1.1.
Adequate organ function as determined by laboratory tests.
Disqualifiers
Patients who have not recovered to NCI CTCAE grade ≤ 1 from an adverse event (AE) due to cancer therapeutics except the chemotherapy-associated peripheral neuropathy (motor or sensory) or alopecia. Patients with ongoing and adequately controlled endocrine immune-related AEs are considered stable and eligible for enrollment.
The washout period for cancer therapeutic drugs should be 5 half-life or 21 days for chemotherapy, whichever is shorter; or 28 days for monoclonal antibody therapy. Palliative radiotherapy for painful metastases or metastases in potentially sensitive locations (e.g., epidural space) ≥ 7 days prior to the first dose of study drug. Best supportive care, such as thyroxine, insulin, steroid replacement treatment, blood transfusion and therapy for non-cancer conditions are allowed.
Patients who are currently enrolled in any other clinical trial testing an investigational agent or device, or with concurrent anticancer treatment (except palliative bone-directed radiotherapy), immune therapy, or cytokine therapy or anticipated to require another antineoplastic therapy during the study.
Patients who are on chronic systemic steroid therapy at doses higher than 10 mg/day prednisone or equivalent within 7 days before first treatment.
Trial design
Design model
Single group
Treatments tested in this trial
ONC-841
DrugONC-841 (anti-SIGLEC10) is a humanized antibody that binds to human sialic acid-binding Ig-like lectin 10 and has a human immunoglobulin G4 (IgG4) Fc domain.
Treatment groups
72 Participants
are divided into 1 treatment groupGroup A: ONC-841Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Dose Limiting Toxicity (DLT)
The number of subjects who have Dose limiting toxicity (DLT) as defined by protocol DLT criteria during the first cycle of study drug, ONC-841, administration.
Time frame
28 Days2
Maximum Toxicity Dose (MTD)
Maximal tolerable dose (MTD), the study drug, ONC-841, dose level that has two out of six subjects who have DLT.
Time frame
28 DaysSecondary outcomes
1
Cmax of ONC-841
The highest Serum concentration of ONC-841 after IV infusion at cycle 1 and cycle 3 from different timepoints (within 60 minutes before dosing, 60 minutes post-dose, 6 hours post-dose, 24 hours post dose, day 8, 15 and 21 post-dose) after drug administration.
Time frame
84 days2
The serum half-life of ONC-841
To determine the drug concentration in serum samples that are taken in various timepoints (Cycle 1 and Cycle 3: within 60 minutes before dosing, 60 minutes post-dose, 6 hours post-dose, 24 hours post dose, day 8, 15 and 21 post-dose. Cycle 2 and Cycle 4-13: within 60 minutes before dosing and 60 minutes post-dose) during the treatment in order to calculate drug half life.
Time frame
84 daysSponsors and contacts
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Source ClinicalTrials.gov