Clinical Trials Logo

Clinical Trial Summary

This is a dose escalation, MTD expansion (Phase 1b) and cohort expansions (Phase 2) study to assess the safety and tolerability of a combination of NAP with durvalumab in subjects with selected advanced or metastatic solid tumors.


Clinical Trial Description

This Phase 1b, open-label, multicenter (n=3-5), prospective, dose-finding and MTD cohort expansion study, recruits patients with previously treated solid tumors known with high likelihood of 5T4 antigen expression on tumor cells. Patients in the dose-escalation part are treated with the combination of NAP and durvalumab using a fixed dose of durvalumab and the 3+3 design for NAP dose escalations. The (Maximum Tolerated Dose (MTD) of NAP for the combination treatment will be established based on Dose Limiting Toxicities (DLTs) occurring during the first cycle of the treatment. A second dose escalation part is performed at the second highest safe dose in the dose escalation phase, pre-treated with obinutuzumab (anti-CD20), for elimination of anti-drug antibodies (ADAs) to NAP. In this part, the safety of the NAP-durvalumab combination are assessed with obinutuzumab given prior to the initiation of that regimen. MTD expansion part, in which approximately 10-15 patients are treated at the confirmed MTD of NAP. Ten additional patients are enrolled at the previous dose level to assess whether a lower dose may achieves a better risk-benefit balance. This cohort recruits patients with the same tumor types as in the escalation part, as well as 5T4-positive colorectal cancer (CRC) and gastro-esophageal cancer (GE). Measurable disease is required. This expansion cohort will help assess the biologic activity of the combination and to gain some preliminary insights on its potential antitumor activity. Additional group of approximately 10 patients ("Obi (-7)" group) will be enrolled to test an abbreviated regimen of obinutuzumab pre-treatment. A single infusion of 1000 mg obinutuzumab will be administered on day (-7) prior to initiation of Cycle 1 of the combination of NAP and durvalumab. NAP and durvalumab will be given in the same dose and regimen as in this MTD expansion cohort. The following solid tumors known to have > 80% probability of 5T4 expression and thus may be included in both the dose escalation phase and the MTD expansion: breast cancer, epithelial ovarian cancer, cervical and endometrial cancer, pancreatic cancer, renal and urothelial cancer, head and neck, mesothelioma, melanoma, hepatic carcinoma, prostate cancer, and Non-Small Cell Lung Cancer (NSCLC). Prior PD-1 or PD-L1 therapy is acceptable. ;


Study Design


Related Conditions & MeSH terms

  • Bladder Cancer
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Cervical Squamous Cell Carcinoma
  • Colorectal Cancer Metastatic
  • Endometrial Cancer
  • Endometrial Neoplasms
  • ER+ Breast Cancer
  • GastroEsophageal Cancer
  • Head and Neck Squamous Cell Carcinoma
  • Hepatocellular Carcinoma
  • HER2-negative Breast Cancer
  • Melanoma
  • Mesothelioma
  • NSCL2 Gene Mutation
  • NSCLC
  • Ovarian Cancer
  • Pancreatic Adenocarcinoma
  • Prostate Cancer
  • Renal Cell Carcinoma
  • Squamous Cell Carcinoma of Head and Neck
  • Triple Negative Breast Cancer
  • Triple Negative Breast Neoplasms
  • Urothelial Cancer

NCT number NCT03983954
Study type Interventional
Source NeoTX Therapeutics Ltd.
Contact
Status Active, not recruiting
Phase Phase 1
Start date October 10, 2019
Completion date October 1, 2026

See also
  Status Clinical Trial Phase
Recruiting NCT05540392 - An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues Phase 1/Phase 2
Recruiting NCT05613023 - A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT Phase 3
Recruiting NCT05156424 - A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer Phase 1/Phase 2
Completed NCT03177759 - Living With Prostate Cancer (LPC)
Completed NCT01331083 - A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer Phase 2
Recruiting NCT05540782 - A Study of Cognitive Health in Survivors of Prostate Cancer
Active, not recruiting NCT04742361 - Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer Phase 3
Completed NCT04400656 - PROState Pathway Embedded Comparative Trial
Completed NCT02282644 - Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry N/A
Recruiting NCT06037954 - A Study of Mental Health Care in People With Cancer N/A
Recruiting NCT06305832 - Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer Phase 2
Recruiting NCT05761093 - Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
Completed NCT04838626 - Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection Phase 2/Phase 3
Recruiting NCT03101176 - Multiparametric Ultrasound Imaging in Prostate Cancer N/A
Completed NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer N/A
Completed NCT00341939 - Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
Completed NCT01497925 - Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer Phase 1
Recruiting NCT03679819 - Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
Completed NCT03554317 - COMbination of Bipolar Androgen Therapy and Nivolumab Phase 2
Completed NCT03271502 - Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy N/A