← Back to Search

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
Demonstrate adequate organ function
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 25 months
Awards & highlights

STARLING Trial 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.Check my eligibility
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.See study design
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.

STARLING Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer has not responded to standard treatments.
Select...
My organs are functioning well.
Select...
I have a tumor that can be measured and sampled for treatment.
Select...
I am fully active or can carry out light work.

STARLING Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety and tolerability
Secondary outcome measures
Estimated Disease Control Rate (DCR)
Estimated Duration of Response (DoR)
Proportion of patients with a response (ORR)

STARLING 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 2
~2010

Find a Location

Who is running the clinical trial?

Turnstone Biologics, Corp.Lead Sponsor
6 Previous Clinical Trials
91 Total Patients Enrolled
Ines Verdon, MDStudy DirectorTurnstone Biologics, Corp.
1 Previous Clinical Trials
27 Total Patients Enrolled

Media Library

Pembrolizumab (PD-1 Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05576077 — Phase 1
Breast Cancer Research Study Groups: Head and Neck Squamous Cell Carcinoma, Non-Small Cell Lung Cancer, Breast Cancer, Colorectal carcinoma, Uveal Melanoma, Cutaneous Melanoma
Breast Cancer Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT05576077 — Phase 1
Pembrolizumab (PD-1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05576077 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does Uveal Melanoma pose any health risks to those affected by it?

"Due to the lack of research around Uveal Melanoma, our team at Power has allocated a score of 1. This is because this trial is still in its early stage with limited data regarding safety and efficacy."

Answered by AI

Does this research include elderly participants over the age of eighty-five?

"This clinical trial is open to individuals between 18 and 70 years of age. For minors, there are 123 trials whilst 2494 studies have been designed for elderly patients."

Answered by AI

How many individuals are being recruited to participate in this trial?

"Affirmative. Clinicaltrials.gov indicates the commencement of recruitment for this medical trial on January 17th, 2023 and its most recent update was on the 27th of that same month. This study is looking to recruit 30 patients split between two locations."

Answered by AI

Are there vacancies left within this clinical experiment?

"This clinical trial, initially posted on January 17th 2023 and last modified roughly ten days later, is currently searching for participants. Patient recruitment information can be found at the aforesaid website."

Answered by AI

Who fulfills the criteria for participating in this experiment?

"This trial seeks thirty individuals between the ages 18 and 70 who are suffering from breast cancer. Additional prerequisite criteria include: a metastatic or advanced form of colorectal adenocarcinoma, uveal melanoma that is resistant to standard treatment paths, availability for response assessment in at least one target lesion, an ECOG performance status of 0 or 1, as well as adequate organ function. There may be additional inclusion parameters not mentioned here."

Answered by AI
~23 spots leftby Dec 2024