Not Yet RecruitingPhase 1/2

A Study of Anti-PD-1 and LAG-3 Bispecific Antibody(AK129) Combined With Chemotherapy With or Without Cadonilimab in the First-line Treatment of Unresectable Locally Advanced or Metastatic G/ GEJ Adenocarcinoma

China294 participantsStarted 2024-09-10

Plain-language summary

Phase Ib/II clinical study of AK129 combined with chemotherapy with or without cadonilimab in first-line treatment of advanced HER2 negative gastric cancer or gastroesophageal junction adenocarcinoma

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The subject must sign the written informed consent form(ICF) voluntarily.
. Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.
. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (GEJ).
. Inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
. Participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
. According to RECIST v1.1 criteria, subjects had at least one measurable tumor target.

Exclusion criteria

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence and severity of adverse events(AE)

Timeframe: Up to approximately 2 years

Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR)

Timeframe: Up to approximately 2 years

Incidence of dose-limiting toxicity(DLT)

Timeframe: Up to approximately 2 years

Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension

Timeframe: Up to approximately 2 years

Objective Solution Rate (ORR) based on RECIST v1.1

Timeframe: Up to approximately 2 years

Trial details

NCT IDNCT06586294

SponsorAkeso

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Xiao Xu, MD, PhD

+86 (0760) 8987 3999 clinicaltrials@akesobio.com

View on ClinicalTrials.gov More Gastric Adenocarcinoma trials

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. The subject must sign the written informed consent form(ICF) voluntarily.
. Aged ≥ 18 to ≤ 75 years,male and female at the time of signing the ICF.
. Histologically confirmed adenocarcinoma of the gastric or gastroesophageal junction (GEJ).
. Inoperable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
. Participants had not previously received systemic therapy for locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma.
. According to RECIST v1.1 criteria, subjects had at least one measurable tumor target.

Exclusion criteria

What they're measuring

Incidence and severity of adverse events(AE)

Timeframe: Up to approximately 2 years

Incidence of serious adverse events(SAE) and suspected unexpected serious adverse reactions(SUSAR)

Timeframe: Up to approximately 2 years

Incidence of dose-limiting toxicity(DLT)

Timeframe: Up to approximately 2 years

Clinically significant changes in safety/laboratory evaluation parameters and AEs that led to treatment termination or suspension

Timeframe: Up to approximately 2 years

Objective Solution Rate (ORR) based on RECIST v1.1

Timeframe: Up to approximately 2 years