What side effects are associated with this type of intervention?

Common treatments for tumors that involve immune modulation or direct anti-tumor activity, such as immune checkpoint inhibitors (e.g., pembrolizumab, nivolumab), often have side effects including fatigue, rash, diarrhea, and pruritus. More severe adverse events can include pneumonitis, colitis, hepatitis, endocrinopathies, and other immune-related adverse events. These treatments can also cause infusion reactions and, in some cases, severe infections due to immune system modulation. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of tumors that involve immune modulation or direct anti-tumor activity. Notable examples include immune checkpoint inhibitors such as pembrolizumab and nivolumab, which target PD-1, and ipilimumab, which targets CTLA-4. These drugs have been approved for various cancers, including melanoma and non-small cell lung cancer. Combination therapies like nivolumab with ipilimumab have also been approved for renal cell carcinoma and melanoma. Additionally, CAR T-cell therapies such as axicabtagene ciloleucel have been approved for certain lymphomas, and tyrosine kinase inhibitors like cabozantinib have been approved for medullary thyroid cancer.

What other types of research exist?

<ol> <li>Dostarlimab: An immune checkpoint inhibitor that can be co-administered with other treatments for enhanced efficacy in solid tumors.</li> <li></li> </ol> Cabozantinib (XL184): A tyrosine kinase inhibitor with demonstrated activity in medullary thyroid cancer and other solid tumors. 3. Belantamab mafodotin: An antibody-drug conjugate targeting B-cell maturation antigen, effective in relapsed or refractory multiple myeloma. 4. Nivolumab and Ipilimumab: Immune checkpoint inhibitors used in combination for advanced renal cell carcinoma and melanoma. 5. Pembrolizumab: An anti-PD-1 antibody with broad applications in various cancers, including melanoma and renal cell carcinoma.

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Unknown

GSK3745417 for Cancer

Phase 1

Waitlist Available

Research Sponsored by GlaxoSmithKline

Eligibility Criteria Checklist

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

Must have

Participant must be more than or equal to (>=)18 years of age

Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1

Must not have

History of vasculitis at any time prior to study treatment

Current unstable liver or biliary disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Summary

This trial is testing a new drug, GSK3745417, alone and with another drug, dostarlimab, in patients whose solid tumors have not responded to other treatments or have returned. The goal is to find the best dose and see if these drugs can help shrink the tumors. Dostarlimab is recently approved for the treatment of various cancers, including certain types of endometrial cancer.

Who is the study for?

Adults with advanced solid tumors that have worsened or not responded to existing treatments can join this trial. They must be at least 18, have a confirmed diagnosis, measurable disease, good organ function, and an ECOG performance status of 0-1. Women who can bear children need to use effective contraception and cannot be pregnant or breastfeeding.

What is being tested?

The study is testing GSK3745417 alone (Part 1A) or combined with dostarlimab (Part 2A) in patients with stubborn solid tumors. It's in the first phase where they're figuring out safe doses and checking how well it works by gradually increasing the dose.

What are the potential side effects?

Possible side effects are not detailed but may include typical reactions to cancer therapies such as immune-related issues due to dostarlimab (an immunotherapy drug), infusion reactions, fatigue, digestive problems, skin changes, 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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I am 18 years old or older.

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I am fully active or can carry out light work.

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I can provide a new tissue sample for testing.

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My cancer is confirmed to be advanced through testing.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had vasculitis in the past.

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My liver condition is stable.

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I have a history of serious bleeding or blood clotting issues.

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I have had issues like severe gut inflammation or blockage in the last 6 months.

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I have fully recovered from any recent surgeries before starting the study treatment.

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I have had a bone marrow or organ transplant.

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I haven't used any cancer drugs or investigational devices in the last 28 days or within 5 half-lives of the drug.

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I have a history or risk of heart problems.

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I have been treated with a STING agonist before.

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I have had pneumonitis treated with steroids or have it now.

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I have a history of specific lung conditions or currently have lung inflammation.

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I do not have an active infection needing treatment, HIV, or hepatitis B/C.

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I have had fluid build-up causing symptoms that were not controlled in the last 6 months.

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My heart's electrical activity (QTcF) is within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation CohortExperimental Treatment2 Interventions

Group II: Part 1A: Participants receiving GSK3745417, Dose-escalation CohortExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

2020

Completed Phase 3

~1760

0 / 18Eligibility criteria met

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

Common treatments for tumors often involve immune modulation and direct anti-tumor activity. Immune checkpoint inhibitors, such as PD-1/PD-L1 and CTLA-4 inhibitors, enhance the immune system's ability to attack cancer cells by blocking proteins that suppress immune responses. Targeted therapies, like BRAF inhibitors, focus on specific genetic mutations within cancer cells to inhibit their growth and survival. These mechanisms are important for tumor patients as they provide more personalized and effective treatment options, potentially improving outcomes and reducing side effects compared to traditional chemotherapy.

Dual Targeting Autoimmunity and Cancer: From Biology to Medicine.

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Who is running the clinical trial?

GlaxoSmithKlineLead Sponsor

4,788 Previous Clinical Trials

8,176,710 Total Patients Enrolled

5 Trials studying Tumors

1,919 Patients Enrolled for Tumors

GSK Clinical TrialsStudy DirectorGlaxoSmithKline

3,601 Previous Clinical Trials

6,144,917 Total Patients Enrolled

1 Trials studying Tumors

12 Patients Enrolled for Tumors

Media Library

GSK3745417 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT03843359 — Phase 1

Tumors Research Study Groups: Part 2A: Participants receiving GSK3745417 + dostarlimab, Dose escalation Cohort, Part 1A: Participants receiving GSK3745417, Dose-escalation Cohort

Tumors Clinical Trial 2023: GSK3745417 Highlights & Side Effects. Trial Name: NCT03843359 — Phase 1

GSK3745417 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03843359 — Phase 1

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