Recruiting nowPhase 1
What this trial is trying to do
The researchers are testing AUR107 for the first time in people with relapsed advanced cancers to find out how the drug behaves in the body, what biological effects it has, and what dose may be suitable. The trial is also assessing whether treatment causes dose-limiting toxicities, meaning side effects severe enough to prevent increasing the dose.
The aim is to establish a tolerable and biologically active dose for later studies, rather than to compare AUR107 with an existing treatment or demonstrate longer survival or delayed cancer growth. Any benefit to patients is not yet being tested reliably in this small, early-phase trial.
Worth knowing: This is an open-label, non-randomised, first-in-human Phase 1 trial focused mainly on safety, with no comparison group.
Written from the trial's own registry entry to explain what the researchers are testing and why. Nothing here is a result — this trial has not reported one — and it is not a view on whether the treatment works or on whether it would suit you.
| Registry number | NCT05865002 |
|---|---|
| Recruitment | Recruiting now |
| Phase | Phase 1 |
| Design | open label |
| Taking part | 50 people (planned) |
| Who can join | aged 18 Years and over |
| Run by | Aurigene Discovery Technologies Limited |
| Started | |
| Main results expected | |
| Record last updated |
What is being tested
- Drug AUR107
What it is measuring
First cycle Dose Limiting Toxicities (DLT)
This is the trial's main question — the one it is designed and sized to answer. Anything else it reports is a secondary finding, and secondary findings are far more likely to be chance.
Phase 1. Tests safety and dose in a small group. Some people do benefit, but that is not what the trial is designed to find out.
How the researchers describe it
An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.
Written by the trial’s sponsor, quoted from its ClinicalTrials.gov record.
What this trial is looking for
- Any genotype
- Metastatic
- Already treated
Read automatically from the criteria below, to make the list searchable. It is a summary of what the text mentions, not a decision about whether you qualify — and where the two disagree, the criteria are right and this is wrong.
Who the trial is looking for
Inclusion Criteria
1. Males and females ≥ 18 years of age.
2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1.
3. Acceptable bone marrow and organ function at screening as described below:
1. ANC ≥ 1500/μL (without WBC growth factor support)
2. Platelet count ≥ 100,000/μL without transfusion support
3. Hemoglobin ≥ 9 g/dL (Transfusion is allowed to achieve this Hb)
4. Total Bilirubin ≤ 1.5 x ULN; (Patients with known Gilbert's syndrome are allowed with a Total Bilirubin ≤ 2.5 x ULN)
5. AST (SGOT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
6. ALT (SGPT) ≤ 3 x ULN (≤ 5 × ULN if known liver metastases)
7. Creatinine clearance (CrCl) ≥ 60 mL/min (either measured or estimated by the Cockcroft-Gault formula).
4. Ability to swallow and retain oral medications.
5. Histopathological diagnosis of a solid tumor. Note: The solid tumors must be in Stage IV at screening.
6. Evidence of measurable disease per RECIST, v1.1 for solid tumors.
7. Standard curative measures do not exist, and the patient must have exhausted all effective therapies available locally.
Notes
7a. At a minimum, solid tumor patients must have received at least two lines of systemic therapies in the metastatic incurable settings (these two lines must be in the metastatic setting and not in the earlier stage of cancer).
7b.
This is an extract. Whether you qualify is decided by the trial team against the full criteria, not by reading this page. Read the full eligibility criteria
Where it is running
Running at 37 sites. Listed in: India.
Individual hospitals, and whether each is currently open, are listed on the registry record. Sites open and close throughout a trial.
Worth asking your oncology team
Being listed here is not a recommendation, and no one page can tell you whether a trial is right for you. These are the questions it raises.
- Is this trial open at a hospital I could realistically travel to?
- Given my stage, my previous treatment and my tumour's molecular profile, would I be eligible?
- What would I be giving up by joining — is the comparison arm the treatment I would otherwise be having?
- What is already known about the safety of what is being tested?
- This trial recruits across several cancer types rather than being designed around bowel cancer. Is there evidence it does anything in mine?
The source
Registry record NCT05865002, registered by Aurigene Discovery Technologies Limited on ClinicalTrials.gov, a public database run by the US National Library of Medicine. The details on this page come from that record and are only ever as current as the sponsor has kept it.
This is a listing of a registered clinical trial, reproduced for information. It is not a recommendation, this site has no connection to the trial or its sponsor, and being listed here says nothing about whether the treatment works. Talk to your own oncology team before pursuing any trial.
This article summarises published research for general information. It is not medical advice, and it is not a substitute for a conversation with your own oncology team, who know your case. Do not start, stop, or change any treatment or supplement on the basis of what you read here.