AK104 in Combination With AK112 Plus Chemotherapy(SOX/XELOX) as First-line Treatment for Advanced G/GEJ Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorHarbin Medical University

About this trial

The goal of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and anti-tumor activities of cadonilimab in combination with Ivonescimab plus chemotherapy as first-line therapy in adult subjects with HER2 negative、advanced or metastatic gastric (G) or gastroesophageal junction (GEJ) cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Imaging examination confirmed unresectable locally advanced or metastatic gastric cancer (GC) or gastroesophageal binding cancer (GEJC), and histopathologically confirmed adenocarcinoma, with at least one measurable tumor lesion (spiral CT or MR scan ≥10mm, gonorrhea The short diameter of sling is ≥15mm, which meets the RECIST 1.1 standard); the lesion that has received radiotherapy is not selected as the target lesion, unless the radiotherapy lesion is the only measurable lesion and is clearly advanced according to imaging judgment, it can be considered as the target lesion;

Subjects have not received prior systemic therapy for locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of the gastroesophageal junction. For subjects who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the time between disease progression and last treatment should be at least 6 months;

HER2 is negative. HER2 negative is defined as: IHC 0/1+, or IHC 2+ and FISH/ISH negative (HER2: CEP17 ratio <2). FISH can be replaced by locally available and accepted ISH methods (such as DISH);

Disqualifiers

known as squamous carcinoma, undifferentiated cancer or other tissue types of gastric cancer, or adenocarcinoma mixed with other tissue types of gastric cancer;

HER2 positive stomach cancer patients: define IHC 3+, or IHC 2+ and FISH/ISH positive;

Previously received immune checkpoint inhibitors (such as anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies, etc.), immune checkpoint agonists (such as antibodies to ICOS, CD40, CD137, GITR, OX40 targets, etc.) , immune cell therapy and other treatment of any immune mechanism for tumors;

In the first 14 days of randomization, there is still uncontrollable pleural hydration and ascites after puncture drainage and other treatments. Imaging shows that a small number of or medium chest and ascites patients can be selected for the study;

Trial design

Design model

Single group

Treatments tested in this trial

  • Cadonilimab

    Biological/Vaccine

    Subjects will receive AK104 by intravenous administration

  • Ivonescimab

    Biological/Vaccine

    Subjects will receive AK112 by intravenous administration

  • XELOX

    Drug

    Subjects will receive AK104 and AK112 in combination with XELOX(oxaliplatin and capecitabine)

  • SOX

    Drug

    Subjects will receive AK104 and AK112 in combination withSOX(oxaliplatin and Tegafur)

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: AK104+AK112+SOX/XELOXExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Objective Response Rate,ORR

Defined as the proportion of patients who achieved complete response (CR) and partial response (PR) according to RECIST v1.1.

Time frame
6 months

Secondary outcomes

1

Progression free Survival

Defined as the time between signing the informed consent form to the disease progression (according to RECIST v1.1 criteria) or death due to any cause.

Time frame
1 year
2

Overall survival

Defined as the time between signing the informed consent form to death due to various causes.

Time frame
2 years
3

Disease Control Rate

Defined as the proportion of patients who achieved complete response (CR), partial response (PR), and stable disease (SD) according to RECIST v1.1.

Time frame
6 months
4

Duration of Response

Defined as the time from response(when CR or PR is first diagnosed) to disease progression or death due to any cause.

Time frame
6 months

Other outcomes

Sponsors and contacts

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