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PD-1 Inhibitor

TBio-4101 + Pembrolizumab for Advanced Solid Cancers (STARLING Trial)

Phase 1

Recruiting

Research Sponsored by Turnstone Biologics, Corp.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Advanced or metastatic breast carcinoma, colorectal adenocarcinoma, uveal melanoma, cutaneous melanoma, non-small cell lung cancer, or head and neck squamous cell carcinoma that has failed or is refractory to standard of care therapy

Have at least one target lesion that can be used for response assessments and have at least 1 tumor amenable for tissue harvest for TIL manufacturing

Must not have

Prior cell therapy or organ transplant

LVEF ≤ 45%

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 25 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will investigate a potential new cancer treatment using cells from the patient's own tumor.

Who is the study for?

This trial is for adults with certain advanced cancers (like breast, colorectal, melanoma, lung cancer) that haven't responded to standard treatments. They must have a lesion measurable for response assessment and a tumor suitable for TIL production. Good organ function and an ECOG status of 0 or 1 are required. Those with heart issues, other active cancers in the last 3 years, immune deficiencies, severe infections like HIV/HBV/HCV/CMV/WNV/HTLV I/II/syphilis or brain metastases aren't eligible.

What is being tested?

The study tests TBio-4101 (a personalized T-cell therapy made from the patient's own tumor cells) combined with Pembrolizumab (an immunotherapy drug). It aims to see if this combo can help patients whose solid tumors didn't improve after standard care.

What are the potential side effects?

Possible side effects include reactions related to the immune system attacking normal organs (autoimmunity), infusion-related reactions from Pembrolizumab, fatigue, flu-like symptoms due to IL-2 in TIL culture process and potential complications from harvesting tumor tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not responded to standard treatments.

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I have a tumor that can be measured and sampled for treatment.

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I am fully active or can carry out light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a cell therapy or organ transplant before.

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My heart's pumping ability is reduced.

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My lung function tests show reduced capacity.

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I have another cancer that is getting worse or was treated in the last 3 years.

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I have an immune system disorder or am on long-term steroids or other immune-weakening medicines.

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I am currently infected with a virus such as HIV, hepatitis B or C, syphilis, West Nile virus, HTLV I/II, or CMV.

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I do not have serious heart conditions and am cleared by a cardiologist if over 60.

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I am on a blood thinner that cannot be stopped or changed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 25 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~25 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 25 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety and tolerability

Secondary study objectives

Estimated Disease Control Rate (DCR)

Estimated Duration of Response (DoR)

Proportion of patients with a response (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Uveal MelanomaExperimental Treatment2 Interventions

Patients with advanced, metastatic uveal melanoma.

Group II: Non-Small Cell Lung CancerExperimental Treatment2 Interventions

Patients with non-small cell lung cancer who have experienced disease progression following platinum containing chemotherapy and/or PD-1 or PD-L1 inhibitor.

Group III: Head and Neck Squamous Cell CarcinomaExperimental Treatment2 Interventions

* Patients with head and neck squamous cell carcinoma who have received no prior therapy for metastatic disease * Patients with head and neck squamous cell carcinoma who are PD-1/PD-L1 inhibitor naïve at the time of TIL harvest and will be treated with TBio-4101 at the time of progression, inadequate response or intolerance to the PD-1/PD-L1 inhibitor-based standard of care regimen given on study.

Group IV: Cutaneous MelanomaExperimental Treatment2 Interventions

Patients with cutaneous melanoma who have experienced disease progression following a PD-1 or PD-L1 inhibitor.

Group V: Colorectal carcinomaExperimental Treatment2 Interventions

Patients with advanced, metastatic colorectal adenocarcinoma who have failed or are intolerant to at least one line of therapy that included either irinotecan or oxaliplatin.

Group VI: Breast CancerExperimental Treatment2 Interventions

Patients with locally advanced or metastatic breast cancer that has failed or is intolerant to standard of care therapies. Includes, HER2+, HER 2-, TNBC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 11Eligibility criteria met