475 Participants Needed

TSR-022 for Advanced Cancer

Recruiting at 50 trial locations
UG
EG
Overseen ByEU GSK Clinical Trials Call Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing TSR-022, a new medicine that helps the immune system fight cancer by blocking a protein called TIM-3. TIM-3 has gained prominence as a potential candidate for cancer immunotherapy, where it has been shown that blocking TIM-3 with other treatments enhances the body's ability to fight tumors and suppress their growth. It targets patients with tumors, especially those who may not respond to standard treatments. The goal is to see if this medicine can help the immune system better attack cancer cells.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, participants must not be on systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of the study treatment. It's best to discuss your current medications with the study team to ensure they align with the trial requirements.

What safety data exists for TSR-022 (Cobolimab) in humans?

The research articles do not provide specific safety data for TSR-022 (Cobolimab) in humans, but they discuss its potential in enhancing anti-tumor immunity and its role in cancer immunotherapy.12345

How is the drug TSR-022 (Cobolimab) unique compared to other treatments for advanced cancer?

TSR-022 (Cobolimab) is unique because it targets TIM-3, a protein that can suppress the immune system's ability to fight cancer, making it a novel approach in cancer immunotherapy. This mechanism of action is different from other treatments that may target different pathways or proteins involved in cancer progression.678910

Who Is on the Research Team?

GC

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Negative human immunodeficiency virus (HIV) test at screening
Participant has measurable disease as per RECIST v1.1.
Documented hepatitis C virus (HCV) antibody testing conducted at screening. If HCV antibody is positive, then hepatitis C virus ribonucleic acid (HCV ribonucleic acid (RNA) must be negative.
See 13 more

Exclusion Criteria

I finished palliative radiotherapy less than a week ago.
Participant is pregnant or breastfeeding or expecting to conceive children within the projected duration of the study, starting with the Screening Visit through 150 days after the last dose of study treatment.
Participant must not have a known hypersensitivity to TSR-042 and TSR-022 components or excipients.
See 19 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Part 1 of the study involves dose escalation to determine the recommended Phase 2 dose (RP2D) of TSR-022

Up to 42 days

Dose Expansion

Part 2 of the study evaluates the antitumor activity of TSR-022 in combination with TSR-042 or docetaxel and as monotherapy

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 2 years

What Are the Treatments Tested in This Trial?

Interventions

  • TSR-022
Trial Overview 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).
How Is the Trial Designed?
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

Find a Clinic Near You

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials
4,834
Recruited
8,389,000+
Headquarters
London, UK
Known For
Vaccines & Medicines
Top Products
**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)
Dame Emma Walmsley profile image

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron profile image

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

Published Research Related to This Trial

M6903 is a fully human anti-TIM-3 antibody that effectively blocks TIM-3's interaction with its ligands, leading to enhanced T cell activation, which is crucial for improving anti-tumor immunity.
The combination of M6903 with bintrafusp alfa showed superior anti-tumor efficacy in preclinical models compared to either treatment alone, suggesting a promising avenue for cancer therapy.
Identification and characterization of M6903, an antagonistic anti-TIM-3 monoclonal antibody.Zhang, D., Jiang, F., Zaynagetdinov, R., et al.[2021]
Novel monoclonal antibodies targeting TIM-3 and TIM-4 significantly enhance the effectiveness of cancer vaccines against established B16 murine melanomas, suggesting a new approach to improve cancer immunotherapy.
The combination of anti-TIM-3 and anti-TIM-4 mAbs not only boosts vaccine-induced antitumor responses but also reveals distinct mechanisms of action, with TIM-3 blockade enhancing natural killer cell activity and TIM-4 primarily activating CD8(+) T cells.
Combined blockade of TIM-3 and TIM-4 augments cancer vaccine efficacy against established melanomas.Baghdadi, M., Nagao, H., Yoshiyama, H., et al.[2016]
The blockade of immune checkpoint receptors, like Tim-3 and PD-1, shows promise in reducing tumor progression and enhancing T-cell responses in cancer treatment, particularly in preclinical models.
Tim-3 is expressed by various immune cells and leukemic stem cells, indicating its potential as a target for improving therapies in cancers that currently resist treatment, such as microsatellite-stable colorectal cancer.
Tim-3 finds its place in the cancer immunotherapy landscape.Acharya, N., Sabatos-Peyton, C., Anderson, AC.[2021]

Citations

Identification and characterization of M6903, an antagonistic anti-TIM-3 monoclonal antibody. [2021]
Combined blockade of TIM-3 and TIM-4 augments cancer vaccine efficacy against established melanomas. [2016]
Tim-3 finds its place in the cancer immunotherapy landscape. [2021]
Tim-3, a negative regulator of anti-tumor immunity. [2022]
Tim-3 and its role in regulating anti-tumor immunity. [2022]
Radioimmunoscintigraphy of intracranial glioma xenograft with a technetium-99m-labeled mouse monoclonal antibody specifically recognizing type III mutant epidermal growth factor receptor. [2019]
A new format of single chain tri-specific antibody with diminished molecular size efficiently induces ovarian tumor cell killing. [2006]
Phase I Study of MK-4166, an Anti-human Glucocorticoid-Induced TNF Receptor Antibody, Alone or with Pembrolizumab in Advanced Solid Tumors. [2022]
Development of a fully human anti-GITR antibody with potent antitumor activity using H2L2 mice. [2022]
Therapeutic effect of ansamitocin targeted to tumor by a bispecific monoclonal antibody. [2019]
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