Safety, PK and Efficacy of ONC‑392 in Monotherapy and in Combination of Anti‑PD‑1 in Advanced Solid Tumors and NSCLC

Trial status:Recruitment Complete
Trial ID:
ONC-392-001
NCT ID:
NCT04140526
EudraCT ID:
N/A
EU Trial (CTIS) Number:
N/A
Sponsor:
The sponsor of a clinical trial is the company, institution or individual that takes responsibility for initiating, managing, and/or financing a clinical investigation. BioNTech collaborates with other pharmaceutical companies or institutions (collaborators) to develop certain new medicines. In particular cases BioNTech's collaborators are leading specific clinical trials and are acting as sponsors accordingly.
OncoC4, Inc.
Collaborator:
National Cancer Institute (NCI)
Recruitment Complete

Trial Details

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.

Medical Condition
Lung Cancer
Solid Tumors
Skin Cancer
Head and Neck Cancer
Kidney Cancer
Colorectal Cancer
Sarcoma
Prostate Cancer
Ovarian Cancer
Breast Cancer
Pancreatic Cancer
Oncology
Esophageal Cancer
Stomach Cancer
Cervical Cancer
Salivary Gland Cancer
Bladder Cancer
Study Drug
ONC-392
See more
Pembrolizumab
Docetaxel
Phase
Phase 1/Phase 2
Type
Interventional
Estimated Enrolment
733
Estimated Trial Date
Sep 2020 - Jun 2026

Trial Participant Requirements

Age
18+ years
Sex
Female & Male
Healthy Volunteers
No
Inclusion and Exclusion Criteria
Inclusion criteria
  1. . 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.
    1. 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.

        Please note: tumor types of primary interest in this study are malignant melanoma, renal cell carcinoma, hepatocellular carcinoma, non-small cell lung cancer, head and neck carcinoma, gastric carcinoma, ovarian carcinoma, colorectal cancer, any type of sarcoma.

    2. 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.
    3. 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.
    4. In Part D, patients with recurrent and/or metastatic adenoid cystic carcinoma with disease progression within 12 months are eligible.
    5. Patients must have RECIST V1.1 Measurable disease:
  2. Patient is male or female and \>18 years of age on day of signing informed consent.
  3. Patient must have a performance status of 0 or 1 on the ECOG Performance Scale
  4. Patient must have adequate organ function as indicated by the following laboratory values:

      Hematological: Absolute neutrophil count (ANC) ≥1,500 /mcL; Plateletsa ≥100,000 / mcL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L- without qualifications; Renal: Serum creatinine ≤1.5 X upper limit of normal (ULN); Hepatic: Serum total bilirubin ≤1.5 X ULN; OR Direct bilirubin ≤ ULN for patients with total bilirubin levels \>1.5 ULN; AST (SGOT) and ALT (SGPT) ≤2.5 X ULN, OR ≤5 X ULN for patients with active liver metastases Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN

  5. Patient has voluntarily agreed to participate by giving written informed consent.
  6. Female patient of childbearing potential has a negative urine or serum pregnancy test.
  7. Female and Male patients must agree to use adequate methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy.
Exclusion criteria

    A patient meeting any of the following criteria is not eligible to participate in this study:

  1. 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.
  2. Patients who are currently enrolled in a clinical trial of an investigational agent or device.
  3. Patients who are on chronic systemic steroid therapy at doses \>10 mg/day
  4. Patients who have active symptomatic brain metastasis or leptomeningeal metastasis.
  5. 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.
  6. 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.
  7. Patients with known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  8. Patients who are pregnant or breastfeeding.
  9. For the Part B and Part C Arm D to G, the patients that are deemed to be not suitable for Pembrolizumab.

Trial Locations

Location
Status
Location
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30322
180.9 miles (289.4 km) away from your location
Status
Location
Tennessee Oncology Chattanooga Memorial Plaza
Chattanooga, Tennessee, United States, 37404
209.4 miles (335.0 km) away from your location
Status
Location
Tennessee Oncology - Nashville
Nashville, Tennessee, United States, 37203
265.0 miles (424.0 km) away from your location
Status
Location
Prisma Health
Greenville, South Carolina, United States, 29605
310.6 miles (497.0 km) away from your location
Status
Location
University of Florida Health Cancer Center
Gainesville, Florida, United States, 32610
327.4 miles (523.8 km) away from your location
Status
Location
Ocala Oncology Florida Cancer Affiliates
Ocala, Florida, United States, 34474
354.3 miles (566.9 km) away from your location
Status
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