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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: 17 Apr 2025

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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

  • 14 Apr 2025 According to SynOx Therapeutics media release, the United States Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to emactuzumab for the treatment of TGCT patients that are not amenable to or who would not benefit from surgery supported by data from Phase 1/2 clinical studies demonstrating rapid, robust tumour reduction and durable response combined with a manageable safety profile.
  • 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

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