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A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

Trial Profile

A Phase 1/2, Open-Label, Dose-Escalation, Safety and Tolerability Study of NC318 in Subjects With Advanced or Metastatic Solid Tumors

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Jul 2020

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At a glance

  • Drugs NC-318 (Primary)
  • Indications Advanced breast cancer; Breast cancer; Colorectal cancer; Endometrial cancer; Head and neck cancer; Malignant melanoma; Merkel cell carcinoma; Non-small cell lung cancer; Ovarian cancer; Solid tumours; Squamous cell cancer
  • Focus Adverse reactions; Biomarker; First in man
  • Sponsors NextCure
  • Most Recent Events

    • 13 Jul 2020 According to a NextCure media release, company expects to enroll up to 100 patients with NSCLC, ovarian cancer, head and neck cancer and triple-negative breast cancer.
    • 13 Jul 2020 According to a NextCure media release, company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts. One confirmed partial response has been observed in HNSCC and this indication has been advanced to the stage 2 portion of the Simon 2-stage trial. The company is continuing to assess Siglec-15 (S15) biomarker data as a basis for patient selection.
    • 13 Jul 2020 According to a NextCure media release, the company reported that they do not intend to expand trial in non-small cell lung cancer (NSCLC) and ovarian cancer cohorts in the phase II portion of the Simon 2-stage trial. The analysis of biomarker data for these cohorts has been delayed and is not yet complete.
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