Phase 1 Oesophageal Cancer Trial, Recruiting (NCT06248411)

Phase 1 Oesophageal Cancer Trial, Recruiting NCT06248411 Sponsor: Kyowa Kirin Co., Ltd. Condition: Oesophageal Cancer

Printed from Voxsanity (voxsanity.com.au) — NCT06248411 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Oesophageal Cancer

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:

You must be 18 years of age or older at the time of signing the consent form
You must have given written agreement (informed consent) to take part in the study
Your cancer must not have responded to standard treatments, or standard treatments are not available, or you cannot tolerate them, or you have chosen not to receive them
Your cancer must be measurable using standard imaging methods (a system called RECIST version 1.1)
A certain amount of time must have passed since your last cancer treatment before you can enrol (confirm with trial site for exact timeframes)
You must agree to have a small tissue sample (biopsy) taken from your tumour before treatment begins, or be able to provide a previously collected stored sample if a new biopsy is not possible
Your general health and ability to carry out daily activities must be rated as good or mostly good (scored 0 or 1 on a standard scale called ECOG)
Your blood, liver, kidney, heart, and lung functions must meet certain minimum levels shown in baseline tests (confirm with trial site for exact values)

Additional requirements depending on which part of the trial you may join:

Part 1a: You must have been diagnosed with an advanced or metastatic solid tumour (any type)
Parts 1b, 2a, 2b: You must have been diagnosed with advanced or metastatic oesophageal cancer, or advanced or metastatic head and neck cancer starting in the mouth, throat, voice box, nasal cavity, or sinuses; your cancer must specifically be a type called squamous cell carcinoma; and you must agree to have a tumour biopsy taken after treatment begins

Who may not be able to join:

People who have untreated or symptomatic cancer that has spread to the brain or the lining around the brain and spinal cord
People who have, or have had within the last 5 years, more than one type of cancer at the same time
People who are currently taking steroids or other medicines that suppress the immune system on an ongoing basis
People who have previously had a severe allergic reaction (Grade 3 or higher) to an antibody-based medicine or to ingredients in the study drug
People who still have significant side effects (above Grade 1) from previous cancer treatments that have not yet recovered
People who have active lung inflammation (interstitial lung disease) or a history of this condition
People who have an infection that requires treatment with medicines taken throughout the body (systemic treatment)
People who have a fever of 38.0°C (100.4°F) or higher at the time of enrolment
People who test positive for Hepatitis B, Hepatitis C, or HIV in baseline blood tests

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 28 July 2026

Phase 1: approximately ~10% 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: +81-3-5205-7200

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06248411

Sponsor: Kyowa Kirin Co., Ltd.

Phase: Phase 1

Status: Recruiting

Condition: Oesophageal Cancer

Trial contact: +81-3-5205-7200

More information: https://clinicaltrials.gov/study/NCT06248411

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You must be 18 years of age or older at the time of signing the consent form
You must have given written agreement (informed consent) to take part in the study
Your cancer must not have responded to standard treatments, or standard treatments are not available, or you cannot tolerate them, or you have chosen not to receive them
Your cancer must be measurable using standard imaging methods (a system called RECIST version 1.1)
A certain amount of time must have passed since your last cancer treatment before you can enrol (confirm with trial site for exact timeframes)
You must agree to have a small tissue sample (biopsy) taken from your tumour before treatment begins, or be able to provide a previously collected stored sample if a new biopsy is not possible
Your general health and ability to carry out daily activities must be rated as good or mostly good (scored 0 or 1 on a standard scale called ECOG)
Your blood, liver, kidney, heart, and lung functions must meet certain minimum levels shown in baseline tests (confirm with trial site for exact values)

Additional requirements depending on which part of the trial you may join:

Part 1a: You must have been diagnosed with an advanced or metastatic solid tumour (any type)
Parts 1b, 2a, 2b: You must have been diagnosed with advanced or metastatic oesophageal cancer, or advanced or metastatic head and neck cancer starting in the mouth, throat, voice box, nasal cavity, or sinuses; your cancer must specifically be a type called squamous cell carcinoma; and you must agree to have a tumour biopsy taken after treatment begins

Who may not be able to join:

People who have untreated or symptomatic cancer that has spread to the brain or the lining around the brain and spinal cord
People who have, or have had within the last 5 years, more than one type of cancer at the same time
People who are currently taking steroids or other medicines that suppress the immune system on an ongoing basis
People who have previously had a severe allergic reaction (Grade 3 or higher) to an antibody-based medicine or to ingredients in the study drug
People who still have significant side effects (above Grade 1) from previous cancer treatments that have not yet recovered
People who have active lung inflammation (interstitial lung disease) or a history of this condition
People who have an infection that requires treatment with medicines taken throughout the body (systemic treatment)
People who have a fever of 38.0°C (100.4°F) or higher at the time of enrolment
People who test positive for Hepatitis B, Hepatitis C, or HIV in baseline blood tests

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 28 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 1

Sponsor

Kyowa Kirin Co., Ltd.

Registry

ClinicalTrials.gov

Start date

1 November 2023

Est. completion

31 October 2029

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Dose-limiting toxicity (Only in Part 1a); Adverse Events; Changes in Laboratory Testing Values (Red blood cell count); Changes in Laboratory Testing Values (Hemoglobin concentration); Changes in Laboratory Testing Values (Hematocrit); Changes in Laboratory Testing Values (Reticulocyte); Changes in Laboratory Testing Values (Mean corpuscular volume); Changes in Laboratory Testing Values (Mean corpuscular hemoglobin); Changes in Laboratory Testing Values (Mean corpuscular hemoglobin concentration); Changes in Laboratory Testing Values (White blood cell count); Changes in Laboratory Testing Value...

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: 28 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