A Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of AK132 in Advanced Malignant Solid Tumor

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAkeso

About this trial

This is A Phase I Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of The anti-CLDN18.2 and CD47 Bispecific Antibody AK132 in Advanced Malignant Solid Tumor

Eligibility criteria

Qualifiers

The subjects voluntarily participated in the study with full informed consent and signed written informed consent form.

Males or females aged ≥ 18 to ≤ 75 years at the time of signing informed consent.

Histologically and/or cytologically confirmed locally advanced unresectable or metastatic malignant solid tumors.

The interval between the end of the last systemic anti-tumor treatment and the first dose should be at least 3 weeks.

Disqualifiers

There is active or untreated brain metastases,Meningeal metastases, spinal cord compression, or leptomeningeal disease.

Presence of clinically symptomatic pleural effusion, pericardial effusion, or ascites requiring frequent drainage (≥ 1/month).

Patients who, in the opinion of the investigator, have symptoms or signs suggestive of clinically unacceptable deterioration of the primary disease at the time of screening.

gastrointestinal perforation or gastrointestinal fistula within 6 months before the first dose.

Trial design

Treatments tested in this trial

  • AK132

Treatment groups

72 Participants
are divided into 1 treatment group

Sponsors and collaborators