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Trial Summary

This is a first-in-human, Phase 1, multicenter, open label, single arm, integrated 3-part dose escalation and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK117 administered intravenously to adult subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas.

Acronym:

AK117-101

ACTRN/NCT /ethics:

NCT04349969

Scientific title:

Phase 1, Dose Escalation and Dose Expansion Study of AK117, a CD47-targeting Antibody

Sponsor / Cooperative group:

Akeso

Trial & Patient Characteristics

Cancer TypeAll cancers
Trial TypeTreatment
PhasePhase I
Age Range18 years and older
SexBoth
Tumour Stream -
Cancer StageLocally Recurrent or Locally Advanced, Metastatic or Widespread
Anticipated Start Date2020-04-20
Anticipated End Date2023-09-01

Participating Hospitals

HospitalAshford Cancer Centre Research
Clinical Trial CoordinatorSue Yeend
Emailsyeend@adelaidecancercentre.com.au
Phone08 8292 2240
Principal InvestigatorDr Anna Mislang
Recruitment StatusRecruiting