Spots Global Cancer Trial Database for A Phase 1 Dose Escalation and Expansion Study of AK117
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Trial Identification
Brief Title: A Phase 1 Dose Escalation and Expansion Study of AK117
Official Title: A Multicenter, Phase 1, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK117 in Subjects With Advanced Solid Tumors or Lymphomas
Study ID: NCT04728334
Conditions
Interventions
Study Description
Brief Summary: This is a multicenter, open label, single arm, Phase 1，dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacodynamics, PK, immunogenicity, and preliminary antitumor activity of AK117 administered intravenously to adult subjects with relapsed/refractory advanced or metastatic solid tumors or lymphomas.
Detailed Description: The study comprises a dose escalation phase and a dose expansion phase. The phases will be conducted sequentially. Approximately 162 subjects will be enrolled in this study.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
FuDan University Shanghai Cancer Center, Shanghai, Shanghai, China
Contact Details
Name: Jiong Wu, MD
Affiliation: Fudan University
Role: PRINCIPAL_INVESTIGATOR
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