What side effects are associated with this type of intervention?

Immune checkpoint inhibitors, such as anti-PD-1, anti-PD-L1, and anti-CTLA-4 antibodies, which are similar to the anti-TIM-3 antibody TSR-022, can cause a range of immune-related adverse events (irAEs). These side effects include dermatologic issues like rash and pruritus, gastrointestinal problems such as diarrhea and colitis, hepatic complications like hepatitis, endocrine disorders including thyroid dysfunction and adrenal insufficiency, and less commonly, neurological effects such as neuropathy and encephalitis. Management typically involves immunosuppressive treatments like corticosteroids.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of tumors, targeting proteins such as PD-1, PD-L1, and CTLA-4. Notable drugs include pembrolizumab (Keytruda) and nivolumab (Opdivo), which target PD-1, and have been approved for melanoma, non-small cell lung cancer, and other cancers. Ipilimumab (Yervoy), targeting CTLA-4, is another significant approval for melanoma. These therapies work by enhancing the immune system's ability to fight cancer, similar to the mechanism being studied with the anti-TIM-3 antibody TSR-022.

What other types of research exist?

Promising novel alternatives to TSR-022 for tumor patients in 2024 include: 1) BR102, a bifunctional fusion protein targeting PD-L1 and TGF-β, which has shown efficacy and safety in preclinical studies. 2) Pembrolizumab, an anti-PD-1 antibody, which has demonstrated significant antitumor activity in various cancers. 3) Avelumab, another anti-PD-L1 antibody, which has shown durable tumor regression in Merkel cell carcinoma. 4) Lutetium Lu 177 vipivotide tetraxetan, a radioligand therapy, which has shown clinical efficacy in prostate cancer. These alternatives offer different mechanisms of action and have shown promise in clinical trials.

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Monoclonal Antibodies

TSR-022 for Advanced Cancer

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

No Placebo-Only Group

Summary

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.

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.

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).

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

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

Primary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

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

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

~3120

Carboplatin

2014

Completed Phase 3

~6120

Nivolumab

2015

Completed Phase 3

~4010

TSR-033

2017

Completed Phase 1

~120

Docetaxel

1995

Completed Phase 4

~6550

Pemetrexed

2014

Completed Phase 3

~5550

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Immunotherapies, such as the anti-TIM-3 antibody TSR-022, work by enhancing the immune system's ability to fight tumors. TSR-022 targets TIM-3, a protein that inhibits T-cell activity, thereby boosting the immune response against cancer cells. Similar treatments include PD-1/PD-L1 inhibitors and CTLA-4 inhibitors, which also aim to remove the brakes on the immune system, allowing it to attack tumors more effectively. These mechanisms are important for tumor patients as they offer more targeted and potentially more effective treatment options by leveraging the body's own immune system to combat cancer.

Immunotherapy of heterogenous sarcomas: questions and strategies.