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Monoclonal Antibodies

TSR-022 for Cancer

Phase 1
Recruiting
Research Sponsored by Tesaro, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has histologically or cytologically proven advanced or metastatic NSCLC, and only squamous or nonsquamous cell carcinoma.
Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum-based doublet chemotherapy regimen and an anti-PD-1 or anti-PD-L1 antibody.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights

Study Summary

This trial is testing a new drug to see if it can shrink tumors. The first part will see what dose is safe, and the second part will see if the drug actually works against cancer.

Who is the study for?
This trial is for adults with advanced solid tumors who've had no more than two prior therapies, including a platinum-based chemo and an anti-PD-(L)1 antibody. They must have measurable disease progression, adequate organ function, ECOG performance status of 0 or 1, and a life expectancy of at least three months. Women of childbearing potential need a negative pregnancy test.Check my eligibility
What is being tested?
The AMBER study tests TSR-022, an anti-TIM-3 antibody for treating tumors. It has two parts: dose escalation to find the safe dosage (Part 1), and dose expansion to assess antitumor activity in combination with other drugs like TSR-042 or docetaxel or as monotherapy (Part 2).See study design
What are the potential side effects?
Potential side effects may include immune-related reactions due to the immunotherapy nature of TSR-022 and other drugs being tested. These could involve inflammation in various organs, infusion reactions similar to allergic responses during drug administration, fatigue, blood disorders, and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is advanced or has spread, and it's either squamous or nonsquamous.
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I've had up to 2 treatments for my advanced cancer, including platinum chemotherapy and anti-PD-1/L1 therapy.
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My cancer has worsened after treatments including platinum chemotherapy and anti-PD-1 or PD-L1 therapy.
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I agree to provide a tissue sample from my cancer that was not treated with radiation.
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My advanced lung cancer can be measured by scans.
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I am 18 years old or older.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am expected to live at least 3 more months and can complete 4 cycles of a specific treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1 (a): Number of participants achieving dose limiting toxicity (DLTs)
Part 1 (b,c,d): Number of participants achieving dose limiting toxicity (DLTs)
Part 1 (e) and Part 2: Overall Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
+3 more
Secondary outcome measures
Part 1 (a, b, c, d, f, g, h): ORR by RECIST v 1.1
Part 1 (c, d, e, f, g ,h): Number of participants with ADA to TSR-042
Part 1 (c, d, e, f, g ,h): Serum concentration of TSR-042
+35 more

Trial Design

16Treatment groups
Experimental Treatment
Group I: Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042Experimental Treatment2 Interventions
Group II: Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapyExperimental Treatment1 Intervention
Group III: Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapyExperimental Treatment1 Intervention
Group IV: Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042Experimental Treatment2 Interventions
Group V: Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxelExperimental Treatment2 Interventions
Group VI: Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042Experimental Treatment2 Interventions
Group VII: Part 2: Cohort A Melanoma-TSR-022 with TSR-042Experimental Treatment2 Interventions
Group VIII: Part 2: Cohort A Melanoma-TSR-022 as monotherapyExperimental Treatment1 Intervention
Group IX: Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatinExperimental Treatment4 Interventions
Group X: Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatinExperimental Treatment4 Interventions
Group XI: Part 1f: TSR-022 in combination with TSR-042 and DocetaxelExperimental Treatment3 Interventions
Group XII: Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1)Experimental Treatment2 Interventions
Group XIII: Part 1d: TSR-022 in combination with TSR-042 and TSR-033Experimental Treatment3 Interventions
Group XIV: Part 1c: TSR-022 in combination with TSR-042Experimental Treatment2 Interventions
Group XV: Part 1b: TSR-022 in combination with nivolumabExperimental Treatment2 Interventions
Group XVI: Part 1a: TSR-022 monotherapyExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cisplatin
2013
Completed Phase 3
~1940
Pemetrexed
2014
Completed Phase 3
~5250
TSR-033
2017
Completed Phase 1
~120
Docetaxel
1995
Completed Phase 4
~5620
Carboplatin
2014
Completed Phase 3
~6670
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Tesaro, Inc.Lead Sponsor
56 Previous Clinical Trials
10,081 Total Patients Enrolled
GSK Clinical TrialsStudy DirectorGlaxoSmithKline
3,595 Previous Clinical Trials
6,143,455 Total Patients Enrolled
1 Trials studying Tumors
12 Patients Enrolled for Tumors

Media Library

TSR-022 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02817633 — Phase 1
Tumors Research Study Groups: Part 1f: TSR-022 in combination with TSR-042 and Docetaxel, Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatin, Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1), Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatin, Part 2: Cohort A Melanoma-TSR-022 as monotherapy, Part 2: Cohort A Melanoma-TSR-022 with TSR-042, Part 2:Cohort B Non-small cell lung cancer-TSR-022-monotherapy, Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042, Part 2:Cohort C Colorectal cancer-TSR-022 as monotherapy, Part 2:Cohort C Colorectal cancer-TSR-022 with TSR-042, Part 1a: TSR-022 monotherapy, Part 1b: TSR-022 in combination with nivolumab, Part 1c: TSR-022 in combination with TSR-042, Part 1d: TSR-022 in combination with TSR-042 and TSR-033, Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042, Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxel
Tumors Clinical Trial 2023: TSR-022 Highlights & Side Effects. Trial Name: NCT02817633 — Phase 1
TSR-022 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02817633 — Phase 1

Frequently Asked Questions

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

How many individuals are being enrolled in this clinical investigation?

"Affirmative. Information on clinicaltrials.gov conveys that this trial is actively seeking participants, with the first post dating back to July 8th 2016 and an update being posted in July 4th 2022. The research project will include 369 patients from 43 different locations around the world."

Answered by AI

To which conditions is TSR-022 commonly administered?

"TSR-022 is a typical remedy for metastatic bladder cancer. Additionally, this drug may be used to address small cell lung cancer (SCLC), advanced testicular cancer and other conditions requiring advanced directives."

Answered by AI

In which localities are the experimentations of this trial being conducted?

"Currently, this medical experiment is recruiting from 43 different sites across the nation. Tacoma, Fairfax and Boston are only a few of these participating locations; thus, patients should select their nearest clinic to lessen any transportation related issues."

Answered by AI

Are there any antecedent investigations concerning TSR-022?

"The TSR-022 drug trial was first launched in 1997 at the City of Hope Comprehensive Cancer Center. Since then, 2593 have been completed and 2046 are ongoing trials; many of these taking place within Tacoma, Washington."

Answered by AI

Has the FDA sanctioned TSR-022 for public consumption?

"As a Phase 1 trial, the data on TSR-022's safety and efficacy is limited resulting in it receiving an overall score of 1."

Answered by AI

Is enrollment for this clinical trial still open?

"According to its page on clinicaltrials.gov, this trial is actively recruiting volunteers. The study was initially posted in 2016 and adjusted as recently as July 4th 2022."

Answered by AI

Who else is applying?

What site did they apply to?
GSK Investigational Site
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)
2016. "A Study of TSR-022 in Participants With Advanced Solid Tumors (AMBER)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02817633.
All > Arizona > Kentucky
~33 spots leftby Dec 2024
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