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A Study of AK109 Combined With AK104 in Patients With Advanced Solid Tumors

NCT05142423 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2025-03-12

No results posted yet for this study

Summary

This is a multi-center, open label, phase Ib/II clinical study of AK109 and AK104 to evaluate the safety, tolerability, effectiveness, pharmacokinetic characteristics in advanced solid tumors .

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

AK109+AK104

It includes dose escalation and dose expansion stage. 6-12 patients will be enrolled in dose escalation stage for safety and efficacy. Then select specific dose of AK104 and AK109. Expand for the further safety and efficacy study.

Sponsors & Collaborators

Principal Investigators

  • Nong Xu, MD · The First Affiliated Hospital of Medicine College, Zhejiang University

  • Jianming Xu, MD · The Chinese PLA General Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2021-11-03
Primary Completion
2027-04-30
Completion
2027-04-30

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 NCT05142423 on ClinicalTrials.gov