Phase 2 Stomach Cancer Trial, Recruiting NCT07483554 Sponsor: Innovent Biologics (Suzhou) Co. Ltd. Condition: Stomach Cancer
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Phase 2 Stomach Cancer Trial, Recruiting

NCT07483554
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are willing to sign a consent form and are able to attend the required visits and follow the study procedures
  • People who have at least one tumour that can be measured using standard imaging criteria (called RECIST v1.1)
  • People aged 18 or older (any gender)
  • People whose general physical functioning is rated at a good to mildly limited level on a standard scale used by doctors (ECOG score of 0 or 1)
  • People whose doctors expect them to survive for at least 12 weeks
  • People whose blood counts and organ function (such as liver and kidneys) are at adequate levels
  • People who are able to use effective contraception throughout treatment and for 6 months after treatment ends — this applies to women who could become pregnant, and to men whose partners could become pregnant
  • People whose tumour tissue has tested positive for a protein called CLDN18.2, confirmed by a central laboratory

Who may not be able to join:

  • People who are currently taking part in another interventional clinical trial (trials where a treatment is being tested), unless it is an observational study or a survival follow-up phase only
  • People who have taken a strong CYP3A4 inhibitor (a type of medication that affects how other drugs are processed by the body) within 2 weeks or 5 half-lives before starting the trial drug, whichever is the longer period (confirm with trial site)
  • People who have received anti-cancer treatment within 4 weeks or 5 half-lives of that treatment before starting the trial drug, whichever is the shorter period
  • People who have received radiotherapy aimed at treating or relieving symptoms within 2 weeks before starting the trial drug
  • People who have had a biliary stent placed (a small tube inserted into the bile duct) within 7 days before starting the trial drug
  • People who are planning to receive other anti-cancer treatments while on the trial drug
  • People who have received a live vaccine within 4 weeks before starting the trial drug, or who plan to receive a live vaccine during the study
  • People who have had major surgery within 4 weeks before starting the trial drug, or who have wounds, ulcers, or fractures that have not healed, or who plan to have major surgery during the study
  • People who have not yet recovered from side effects of previous treatments to a mild or resolved level before starting the trial drug
  • People who have had a hole or abnormal opening (perforation or fistula) in their digestive tract within the past 6 months that was not fully resolved by surgery
  • People who have a blockage at the stomach outlet (pyloric obstruction) or who experience repeated vomiting that does not go away
  • People who have had a stent placed in the digestive tract or airway (confirm with trial site)
  • People who have brain or spinal cord metastases that are currently causing symptoms
  • People who have bone metastases that put them at risk of spinal cord compression or paralysis
  • People who have lung disease affecting the tissue between the air sacs (interstitial lung disease) that requires steroid treatment, or a history of such conditions, severe lung function problems, or uncontrolled lung diseases such as pulmonary fibrosis or severe radiation-related lung damage
  • People who have other serious medical conditions that are not well controlled (confirm with trial site)
  • People who have a history of another primary cancer (a separate, unrelated cancer)
  • People with a known history of immune system deficiency
  • People who have previously received an organ transplant or a stem cell transplant from another person
  • People who have previously been treated with a type of cancer drug called a topoisomerase inhibitor-based antibody-drug conjugate
  • People who have a known allergy to the study drug or its ingredients (as applicable to the treatment being received in the trial)
  • People for whom the study drug is medically contraindicated (meaning their doctor has determined the drug should not be used for them)
  • People who have previously had to permanently stop taking the relevant study drug due to side effects
  • People who are pregnant or breastfeeding
  • People whom the trial doctors consider unsuitable for the study for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: +86 512 6956 6088

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Registry
ClinicalTrials.gov
Start date
20 April 2026
Est. completion
31 March 2028

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Objective Response Rate (ORR) evaluated according to RECIST v1.1; Incidence of Adverse Events (AE); Incidence of treatment-emergent adverse Events (TEAE); Incidence of adverse events of Special Interest (AESI); Incidence of serious adverse events (SAE); Number of participants with abnormal laboratory tests results; Number of subjects with clinically significant changes in physical examination results; Number of subjects with clinically significant changes in vital signs

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov