Phase 1 Oesophageal Cancer Trial, Recruiting NCT05865002 Sponsor: Aurigene Discovery Technologies Limited Condition: Oesophageal Cancer
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Phase 1 Oesophageal Cancer Trial, Recruiting

NCT05865002
Recruiting Phase 1

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 are 18 years of age or older
  • You are generally able to carry out daily activities with little or no limitation (your doctor can confirm this based on your activity level)
  • Your blood counts, liver function, and kidney function meet certain minimum levels as measured by blood tests at screening (confirm with trial site)
  • You are able to swallow and keep down oral (by mouth) medications
  • You have been diagnosed with a solid tumor cancer (not blood cancers) that is at Stage 4
  • Your cancer can be measured on scans using standard methods
  • There are no standard treatments left that can cure your cancer, and you have already tried all effective treatments available to you
  • You have received at least two different treatment regimens specifically for your cancer after it spread (metastatic stage), not earlier treatments

Who may not be able to join:

  • You have received cancer treatment (such as chemotherapy, biological therapy, or immune-modifying drugs) within the past 28 days or longer before starting the trial
  • You still have significant side effects from previous cancer treatments that have not mostly resolved (hair loss and nail changes are exceptions)
  • You have had major radiation therapy within the last 21 days before starting the trial
  • You have taken part in another experimental drug trial within the past 28 days or longer before starting
  • You are taking certain medications that strongly affect how the body processes drugs (confirm specific medications with trial site)
  • You have brain or spinal cord spread of your cancer that is currently causing symptoms, has not been treated, or was treated within the last 6 months (those treated more than 6 months ago with no current symptoms may be eligible)
  • You have had major surgery requiring general anesthesia within the last 28 days before starting the trial
  • You have leukemia, myelodysplastic syndrome, multiple myeloma, or lymphoma
  • You currently have an active infection that requires treatment with medication taken throughout the body (preventive antibiotics are allowed)
  • You are known to be HIV positive or have an AIDS-related illness
  • You have active or chronic hepatitis B or hepatitis C infection
  • You are expected to need any other cancer treatment while on this trial
  • You have had certain serious heart or blood vessel problems — such as heart failure, a heart attack, stroke, or blood clot in the lungs — within the past 3 months
  • You have a heart rhythm problem that currently requires treatment, or had one treated in the past 3 months
  • Your heart shows a specific electrical reading (QTc interval) that is too high on an ECG test at screening (confirm with trial site)
  • You have other serious uncontrolled illnesses, such as uncontrolled high blood pressure, active stomach ulcers, significant bleeding problems, or major kidney, liver, lung, hormonal, or psychiatric conditions that could affect your safety or the trial results
  • You currently have or are suspected to have a COVID-19 infection, or have a fever and symptoms suggesting COVID-19 with recent contact with a confirmed COVID-19 case
  • You are pregnant (a pregnancy test will be required for women who could become pregnant)
  • You are breastfeeding, or you are a woman who could become pregnant and are not willing or able to use reliable contraception during the trial

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

Principal Investigator: Akhil Kumar, Aurigene Oncology Limited

Phone: +91 8104730078

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 1
Sponsor
Aurigene Discovery Technologies Limited
Registry
ClinicalTrials.gov
Start date
5 September 2023
Est. completion
1 January 2027

Where this trial is recruiting

🇮🇳 India

Primary endpoints

First cycle Dose Limiting Toxicities (DLT); Safety of AUR107 as measured by the number of participants with treatment-related adverse events (AE) graded according to NCI CTCAE version 5.0; Optimal Biological Dose; Pharmacokinetics: Maximum concentration (Cmax); Pharmacokinetics: Time to Maximum concentration (Tmax); Pharmacokinetics: Area under the curve (AUC); Pharmacokinetics: Mean Residence Time (MRT); Pharmacokinetics: Terminal elimination half-life; Maximum concentration (Cmax) administered under fasting/fed condition; Time to Maximum concentration (Tmax) administered under fasting/fed co...

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