Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Sol… (NCT04140526) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
United States733 participantsStarted 2020-09-16
Plain-language summary
This is a First-in-Human Phase IA/IB/II open label dose escalation study of intravenous (IV) administration of ONC-392, a humanized anti-CTLA4 IgG1 monoclonal antibody, as single agent and in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancers.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. . Patients must have a histological or cytological diagnosis of NSCLC or any other type of carcinoma or sarcomas, progressive metastatic disease, or progressive locally advanced disease not amenable to local therapy.
✓. In the Part A Phase I dose escalation study of ONC-392 monotherapy, patients with advanced/metastatic solid tumors of any histology are eligible for participation.
✓. In Part B dose finding of the ONC-392 plus pembrolizumab combination, patients with advanced/metastatic solid tumors of any histology that Pembrolizumab has been approval as standard of care are eligible for participation.
✓. In Part C, patients with pancreatic cancer, triple negative breast cancer, non small cell lung cancer, melanoma, Head and Neck cancer, ovarian cancer, and other solid tumors are eligible.
✓. In Part D, patients with recurrent and/or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible.
✓. Patients must have RECIST V1.1 Measurable disease:
✓. Patient is male or female and \>18 years of age on day of signing informed consent.
✓. Patient must have a performance status of 0 or 1 on the ECOG Performance Scale
Exclusion criteria
✕. Patients who have not recovered to CTCAE ≤ 1 from the AE due to cancer therapeutics. The washout period for cancer therapeutic drugs (such as chemotherapy, radioactive, or targeted therapy) is 21 days, and for antibody drug 28 days.
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What they're measuring
1
Dose limiting toxicity (DLT) in monotherapy
Timeframe: 21 days
2
Maximal tolerable dose (MTD) in monotherapy
Timeframe: 21 days
3
Recommended Phase II Dose (RP2D)
Timeframe: 21 days
4
Rate of treatment related adverse events (TRAE) according to CTCAE v5.0
. Patients who are currently enrolled in a clinical trial of an investigational agent or device.
✕. Patients who are on chronic systemic steroid therapy at doses \>10 mg/day
✕. Patients who have active symptomatic brain metastasis or leptomeningeal metastasis.
✕. Patients who have an active infection requiring systemic IV therapy within 14 days of prior to administration of ONC-392 or combined ONC-392 and Pembrolizumab.
✕. Patients who have a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.
✕. Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.