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A Phase 1 Dose Escalation and Expansion Study of AK117

NCT04728334 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2025-03-03

No results posted yet for this study

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.

Conditions

  • Neoplasms Malignant

Interventions

DRUG

AK117

An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal

Sponsors & Collaborators

Principal Investigators

  • Jiong Wu, MD · Fudan University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2022-01-25
Completion
2023-05-12

Countries

  • China

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04728334 on ClinicalTrials.gov