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A phase 2 basket trial of Leronlimab for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications

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Trial Profile

A phase 2 basket trial of Leronlimab for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Nov 2021

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At a glance

  • Drugs Leronlimab (Primary)
  • Indications Advanced breast cancer; Bladder cancer; Carcinoma; Colon cancer; Gastric cancer; Glioblastoma; Head and neck cancer; Lung cancer; Malignant melanoma; Multiple myeloma; Ovarian cancer; Pancreatic cancer; Solid tumours; Testicular cancer; Triple negative breast cancer; Uterine cancer
  • Focus Therapeutic Use

Most Recent Events

  • 08 Nov 2021 According to a CytoDyn media release, the company has submitted to the U.S. Food and Drug Administration (FDA) an application for Breakthrough Therapy designation (BTD) for leronlimab as a potential treatment for mTNBC. This BTD application is based on the pooled data analysis reported by the company on November 3, 2021.
  • 03 Nov 2021 Pooled data from the Compassionate Use Study (NCT04313075, N =16), the Phase 1b/2 Study ( NCT03838367, N =10), and the Basket Study (N =2) from patients with CCR5+ Metastatic Triple-Negative Breast Cancer who had failed at least two lines of previous therapy are presented in a CytoDyn media release.
  • 01 Jul 2021 According to a CytoDyn media release, triple-negative breast cancer dose escalation portion is completed with the main trial beginning in July.

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