CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 49 enrolled
Drug / intervention
AK117drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04728334
NCT04728334Phase 1Completed
CompareCT.gov

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

Akeso·interventional·Posted Jan 28, 2021·Updated Mar 3, 2025

In Brief

A Phase 1 clinical trial evaluating AK117 for Neoplasms Malignant. Completed, enrolled 49 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeoplasms Malignant
CountriesChina
Collaborators--

Timeline

Phase 1CompletedFinished
202120222023202420252026
First PostedJan 28, 2021
Enrollment StartMar 23, 2021
Primary CompletionJan 25, 2022
Study CompletionMay 12, 2023
TodayJul 1, 2026
Enrollment to primary: 10 monthsPosted 5.4 years ago

Interventions

AK117drug

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