A Study of AK130 in Combination With AK112 for the Treatment of Advanced Pancreatic Cancer

Phase 2RecruitingNCT07114315

Akeso160 enrolled

Overview

This is an open-label, multi-center phase II clinical study consisting of two parts: Part I: To evaluate the safety and efficacy of AK130 combined with AK112 in advanced pancreatic cancer. Part II: To evaluate the safety and efficacy of AK112, either as monotherapy or in combination with AK130, in advanced pancreatic cancer.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

160

Conditions

Pancreatic Cancer

Interventions

AK112DRUG

Following a predefined dose and date.

AK130DRUG

Following a predefined dose and date.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Be able and willing to provide written informed consent. * Have a life expectancy of at least 3 months. * Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Subjects with histologically or cytologically confirmed advanced/metastatic pancreatic ductal adenocarcinoma (PDAC), who have progressed on ≤2 prior lines of systemic therapy. * According to RECIST v1.1, there is at least one measurable lesion. * Has adequate organ function. * All subjects of reproductive potential must agree to use an effective method of contraception, as determined by the Investigator, during and for 90 days after the last dose of study treatment. * Able to to comply with all requirements of study participation (including all study procedures). Exclusion Criteria: * Except for PDAC, the subjects had other malignant tumors within the 5 years prior to enrollment. * There is central nervous system (CNS) metastasis, spinal cord compression, or meningeal metastasis. * There are pleural effusion, pericardial effusion, or ascites with clinical symptoms or requiring repeated drainage. * Prior systemic therapy with either TGF-β inhibitors or anti-angiogenic agents. * There is a history of non infectious pneumonia that requires systemic glucocorticoid treatment. * History of severe bleeding tendency or coagulation dysfunction. * Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. * Pregnant or lactating female subject.

Locations (2)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

Tianjin Medical University Cancer Institute and Hospital

Tianjin, Tianjin Municipality, China

RECRUITING

Outcomes

Primary Outcomes

Number of subjects with adverse events (AEs)

AE refers to any untoward medical occurrence or deterioration of existing medical event after the subject signed the ICF, whether or not considered related to the study treatment.

Time frame: From the time of informed consent signed through 30 days after the last dose of study drug or starting new anti-cancer therapy.

Objective Response Rate (ORR)

ORR is defined as the proportion of subjects with BOR response of CR or PR (based on RECIST Version 1.1).

Time frame: Through study completion, an average of 2 years

Secondary Outcomes

Disease control rate (DCR)

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

Time frame: Through study completion, an average of 2 years

Duration of Response (DoR)

The time from first documented evidence of CR or PR until time of first documented disease progression.

Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Time to response (TTR)

Time between date of start of treatment until first documented response (CR or PR).

Time frame: From date of randomization until the date of first documented response, assessed up to 24 months.

Progression Free Survival (PFS)

PFS is defined as the interval between first dose and the earliest date of disease progression or death due to any cause.

Time frame: Through study completion, an average of 2 years.

Central Contacts

Wenting Li

CONTACT

+86 18116403289 wenting01.li@akesobio.com

Data from ClinicalTrials.gov

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