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Open-label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors

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Trial Profile

Open-label, Multicenter, Dose Escalation Phase Ia/Ib Study With Expansion Phase to Evaluate Safety, Pharmacokinetics and Activity of RO5509554, Administered as an Intravenous Infusion as Monotherapy and in Combination With Paclitaxel in Patients With Advanced Solid Tumors

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 07 Nov 2021

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At a glance

  • Drugs Emactuzumab (Primary) ; Paclitaxel
  • Indications Advanced breast cancer; Giant cell tumour of tendon sheath; Malignant melanoma; Ovarian cancer; Soft tissue sarcoma; Solid tumours
  • Focus Adverse reactions
  • Sponsors Roche

    • Most Recent Events

    • 05 Nov 2020 Results (n=63) assessing long-term clinical benefit and safety of emactuzumab on the largest dTGCT patient cohort published in the European Journal of Cancer
    • 23 Jun 2020 Results from NCT01494688 and NCT02323191 evaluating PK/PD mediated dose optimization of emactuzumab, published in the Clinical Pharmacology and Therapeutics
    • 22 May 2019 Results assessing safety, tolerability and PK and to determine the maximum tolerated dose (MTD) and/or OBD published in the Annals of Oncology
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