All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

Each subject will receive a single dose of AK132 every 2-week cycle (Q2W).

IV infusion, specified dose on specified days.

AK132

Zhifang Yao, M.D.

Yu Lin, M.D.

Ruihua Xu, M.D.

Guoxin Li, M.D.

Jingqi Chen, M.D.

Tao Zhang, M.D.

Tienan Yi, M.D.

Yongchang Zhang, M.D.

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

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

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

incidence and severity of DLT, adverse events (AE), serious adverse events (SAE)

Maximum tolerated dose (MTD), Recommended dose for phase II trial

The PK parameters include serum concentrations of AK132 at different timepoints after AK132 administration.

The immunogenicity of AK132 will be assessed by summarizing the number and percentage of subjects who develop detectable antidrug antibodies (ADAs).

ORR is the proportion of subjects with CR or PR based on RECIST v1.1

Duration of response is defined as the duration from the first documentation of objective response to the first documented disease progression (based on RECIST Version 1.1) or death due to any cause, whichever occurs first.

DCR is defined as the proportion of subjects with CR, PR, or SD (based on RECIST Version 1.1).

Time to response (TTR) is defined as the time from the start of the treatment to the first objective tumor response observed for patients who achieved CR or PR (based on RECIST Version 1.1).

PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first (based on RECIST Version 1.1).

OS defined as the time from the first dose to death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of AK132 in Advanced Malignant Solid Tumor	NCT06166472	Advanced Malign...	AK132	18 Years - 75 Years	Akeso
A Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Preliminary Antineoplastic Activity of AK132 in Advanced Malignant Solid Tumor	NCT06166472	Advanced Malign...	AK132	18 Years - 75 Years	Akeso

Spots Global Cancer Trial Database for ak132

Every month we try and update this database with for ak132 cancer trials from around the world to help patients and their families find trials that might be right for them.
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Spots Global Cancer Trial Database for ak132

Every month we try and update this database with for ak132 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ak132 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.