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Monoclonal Antibodies

Part 2:Cohort B Non-small cell lung cancer-TSR-022 with TSR-042 for Tumors

Phase 1

Recruiting

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

Study Summary

"This trial is testing a new antibody called TSR-022 in humans. The study will have two parts: the first part will focus on finding the right dose of TSR-022, and the second part

Who is the study for?

This trial is for individuals with advanced solid tumors. Participants must meet certain health criteria to join, but specific inclusion and exclusion details are not provided here.Check my eligibility

What is being tested?

The study tests TSR-022, an antibody targeting TIM-3 in the immune system. It's a two-part study: first finding the right dose (dose escalation) and then testing its effectiveness alone or with other drugs like TSR-042 or docetaxel (dose expansion).See study design

What are the potential side effects?

Potential side effects of TSR-022 and other cancer drugs might include immune-related reactions, fatigue, nausea, hair loss from chemotherapy, and possible infusion reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

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

+37 more

Trial Design

17Treatment 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 F- Hepatocellular carcinoma (HCC)-TSR-022 with TSR-042Experimental Treatment2 Interventions

Group VI: Part 2: Cohort E-Non-small cell lung cancer-TSR-022 with docetaxelExperimental Treatment2 Interventions

Group VII: Part 2: Cohort D-TIM-3 selected non-small cell lung cancer (NSCLC)-TSR-022 with TSR-042Experimental Treatment2 Interventions

Group VIII: Part 2: Cohort A Melanoma-TSR-022 with TSR-042Experimental Treatment2 Interventions

Group IX: Part 2: Cohort A Melanoma-TSR-022 as monotherapyExperimental Treatment1 Intervention

Group X: Part 1h: TSR-022 in combination with TSR-042, pemetrexed, and carboplatinExperimental Treatment4 Interventions

Group XI: Part 1g: TSR-022 in combination with TSR-042, pemetrexed, and cisplatinExperimental Treatment4 Interventions

Group XII: Part 1f: TSR-022 in combination with TSR-042 and DocetaxelExperimental Treatment3 Interventions

Group XIII: Part 1e: TSR-022 with TSR-042 (not previously treated with anti-programmed death ligand [PD-{L}]1)Experimental Treatment2 Interventions

Group XIV: Part 1d: TSR-022 in combination with TSR-042 and TSR-033Experimental Treatment3 Interventions

Group XV: Part 1c: TSR-022 in combination with TSR-042Experimental Treatment2 Interventions

Group XVI: Part 1b: TSR-022 in combination with nivolumabExperimental Treatment2 Interventions

Group XVII: 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

Nivolumab

2014

Completed Phase 3

~4750

Carboplatin

2014

Completed Phase 3

~6670

TSR-033

2017

Completed Phase 1

~120

Docetaxel

1995

Completed Phase 4

~5620

Pemetrexed

2014

Completed Phase 3

~5250

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,755 Previous Clinical Trials

8,070,341 Total Patients Enrolled

5 Trials studying Tumors

1,919 Patients Enrolled for Tumors

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,595 Previous Clinical Trials

6,143,455 Total Patients Enrolled

1 Trials studying Tumors

12 Patients Enrolled for Tumors

Frequently Asked Questions

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

Do multiple medical facilities in the United States participate in this research investigation?

"At the current time, patient enrollment is ongoing at a total of 51 locations. These sites are spread across various cities such as Daegu, San Marcos, and Pikeville among an additional 48 other centers. Opting for a site nearest to you can reduce travel obligations when participating in this trial."

Answered by AI

Are there any ongoing opportunities for individuals to participate in this research study?

"According to the details on clinicaltrials.gov, this current trial is actively pursuing eligible participants. It was initially listed on 7/8/2016 and last revised on 3/14/2024."

Answered by AI

What is the upper limit for the number of participants who can be enrolled in this research project?

"Indeed, details on clinicaltrials.gov confirm the ongoing recruitment of participants for this trial. The trial was first listed on July 8th, 2016, and most recently revised on March 14th, 2024. A total of 475 patients are sought from a network of 51 sites."

Answered by AI

What are the potential risks of combining Part 1c: TSR-022 with TSR-042 for individuals undergoing treatment?

"This specific combination of TSR-022 and TSR-042, referred to as Part 1c in the study, has been rated a safety score of 1 by our team at Power. This assessment is based on it being categorized as a Phase 1 trial with minimal available data supporting both its safety and efficacy."

Answered by AI

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/NCT06322693.

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