A Phase 1/2 Study of FS118 in Patients With Advanced Malignancies

Active:	No
Cancer Type:	Head and Neck Cancer Hematopoietic Malignancies	NCT ID:	NCT03440437
Trial Phases:	Phase I Phase II	Protocol IDs:	FS118-17101 (primary) NCI-2018-01062
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	invoX Pharma Limited
NCI Full Details:	http://clinicaltrials.gov/show/NCT03440437

Summary

This study will be conducted in adult participants diagnosed with advanced tumors to
characterize the safety, tolerability, pharmacokinetics (PK), and activity of FS118. This is
a Phase 1/2, multi-center, open-label, multiple-dose, first-in-human study, designed to
systematically assess safety and tolerability, to identify the maximum tolerated dose (MTD)
and/or recommended Phase 2 dose (RP2D) for FS118 in participants with advanced tumors and to
determine the efficacy of FS118 in participants with squamous cell carcinoma of the head and
neck (SCCHN) as monotherapy and in combination with paclitaxel. In addition to safety,
pharmacokinetics, pharmacodynamics, immunogenicity and efficacy will also be assessed.

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