PEAR-TREE 2

Trial Info

Status: Open

Specialty: Renal

Date Opened: 08/07/2024

Planned Close Date: 31/12/2025

Sponsor: Ourotech Limited (trading as Pear Bio)

Principal Investigator: Dr Omi Parikh

Study Title: Prospective Evaluation of AI R&D tool for patient stratification - Trial for Renal immuno-oncology model Experimental Evaluation (PEAR-TREE)

Trial Description

Kidney cancer is a large unmet need in the UK, with 13,000 new patients diagnosed annually, a 52% survival rate, and nearly 5,000 patients dying each year. Pear Bio have developed a diagnostic test that may help oncologists decide on the appropriate course of treatment for patients with cancer. The diagnostic test uses a small tumour sample taken from the patient, alongside a blood sample. Samples are placed in a 3D hydrogel to create microtumours, which act as a proxy for the patient to test treatment options in a laboratory without exposing the actual patient to those treatments. Various approved treatment options are tested in parallel microtumours at Pear Bio's central laboratory. A report is generated on which treatments work best on a given patient's tumour sample, so their oncologist can prescribe an effective treatment.

As Pear Bio's technology is still in early development for kidney cancers, this study will serve to validate the technology. Tumour and blood samples are taken from patients before they start a new line of treatment and used to optimise Pear Bio's technology to test therapies used in the UK or the USA to treat kidney cancer. The main aim of the study is to compare outcomes in patients treated with standard of care drugs and the response we see in the Pear Bio system. This study will enable future studies that are used to guide treatment decisions between multiple approved treatment options on a personalised basis.

Inclusion Criteria

1. Able to give written informed consent prior to admission to this study.

2. Female or male aged ≥ 18 years.

3. Evidence of advanced RCC with intention to receive systemic therapy, defined as:

a. Clinical suspicion of advanced RCC with intention to undergo a clinically-mandated biopsy and subsequent systemic therapy OR

b. Histological evidence of advanced RCC with intention to undergo subsequent systemic therapy and willing to undergo additional research biopsy.

4. At least one lesion evaluable under RECIST 1.1 criteria.

5. Willing to donate at least two additional core biopsy samples prior to starting subsequent systemic therapy.

6. Willing to undergo venous sampling for 40mL of blood.

Exclusion Criteria

1. Early stage kidney cancer.

2. Patients who do not have kidney cancer.

3. Patients with RCC that do not intend to receive systemic therapy.

4. Patients who have already commenced systemic therapy with no plans of changing the systemic therapy after the collection of the core needle biopsy.

5. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator’s opinion, gives reasonable suspicion of a disease or condition that may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.

6. Previous diagnosis of other cancer. Previously treated cancer may be acceptable in some circumstances (e.g. surgery for an unrelated cancer > 5 years ago) after discussion with the Sponsor.

7. No lesions are amenable to biopsy.

Contacts

Research Nurse: Jessica Westney (x3921) Jessica.Westney@lthtr.nhs.uk

Administrators: Zahir Shah & Nathan Fish (x8475)

Link to EDGE

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