What side effects are associated with this type of intervention?

Common treatments for tumors, including chemotherapy, immunotherapy, and targeted therapy, have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infections due to bone marrow suppression. Immunotherapy, such as anti-PD-1 or anti-PD-L1 therapies, can lead to immune-related adverse events like pneumonitis, colitis, hepatitis, and endocrinopathies. Targeted therapies, which inhibit specific molecules involved in tumor growth, can cause side effects such as diarrhea, liver toxicity, skin rashes, and hypertension. These side effects vary in severity and frequency depending on the specific drugs and patient factors.

What prior FDA approvals exist?

Several investigational drugs have received FDA approval for the treatment of tumors, often focusing on novel mechanisms of action. For instance, temozolomide, an oral alkylating agent, is approved for glioblastoma and has shown efficacy in extending survival. Ipilimumab and pembrolizumab, immune checkpoint inhibitors targeting CTLA-4 and PD-1 respectively, are approved for advanced melanoma and have demonstrated significant improvements in survival rates. Additionally, ONC201, an investigational compound targeting mitochondrial metabolism and stress response pathways, is under active investigation for H3 K27M-mutant gliomas. These approvals and ongoing studies reflect the FDA's commitment to advancing cancer treatment through innovative therapeutic approaches.

What other types of research exist?

Promising novel alternatives to GSK4381562 for tumor patients include: 1) Alectinib for ALK-positive non-small cell lung cancer, especially for CNS responses. 2) Crizotinib and Entrectinib for ROS1-positive non-small cell lung cancer. 3) Lorlatinib for advanced ROS1-positive non-small cell lung cancer. 4) Repotrectinib for advanced ROS1 fusion-positive non-small cell lung cancer. 5) Pembrolizumab combined with chemotherapy for metastatic non-squamous non-small cell lung cancer. 6) Cabozantinib for medullary thyroid cancer. These alternatives have shown promising results in clinical trials and may be considered for treatment in 2024.

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GSK4381562 for 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

Female participant is not pregnant or breastfeeding

Histological or cytological documentation of loco-regionally recurrent solid tumors or metastatic solid tumors of specific types

Must not have

Toxicity from previous anticancer treatment including immune-mediated toxicity and myocarditis

Known additional malignancy that progressed or required active treatment within the last 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 27 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests a new drug called GSK4381562 in patients with recurring or spreading tumors who have no other treatment options. It will see how the drug is processed by the body, its safety, and any immune responses it might cause.

Who is the study for?

This trial is for adults with certain advanced solid tumors, like lung, breast, or colorectal cancer, that have worsened after standard treatments or when such treatments aren't suitable. Participants must not be pregnant or breastfeeding and should use effective contraception. They need to have a life expectancy of at least 12 weeks and good organ function.

What is being tested?

The study tests GSK4381562's safety and effects in humans for the first time. It will also look at how the body processes it (pharmacokinetics) and if it triggers immune responses (immunogenicity). Dostarlimab and GSK4428859A are other interventions under investigation.

What are the potential side effects?

As this is a first-time study, specific side effects of GSK4381562 are unknown but may include typical reactions to cancer immunotherapies such as fatigue, flu-like symptoms, allergic reactions, skin rash or inflammation in organs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am not pregnant or breastfeeding.

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My cancer has returned or spread and is of a specific type.

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My current cancer treatment is not working.

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I am fully active or can carry out light work.

Exclusion Criteria

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

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I have experienced side effects from previous cancer treatments.

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I have another cancer that has worsened or needed treatment in the last 2 years.

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My side effects from previous treatments have mostly gone away.

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I have had a bone marrow or organ transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 27 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 27 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 27 months for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Number of Participants With Withdrawals due to AEs

Overall Response Rate (ORR)

Side effects data

From 2021 Phase 2 trial • 53 Patients • NCT03308942

57%

Nausea

52%

Decreased appetite

48%

Constipation

48%

Anaemia

43%

Fatigue

38%

Dyspnoea

24%

Platelet count decreased

24%

Stomatitis

24%

Vomiting

24%

Oedema peripheral

19%

Insomnia

19%

Arthralgia

19%

Pruritus

19%

Blood alkaline phosphatase increased

14%

Chills

14%

Cough

14%

Pain

14%

Neutrophil count decreased

14%

Back pain

14%

Muscular weakness

14%

Diarrhoea

14%

Upper respiratory tract infection

14%

Dysgeusia

14%

Weight decreased

14%

Pneumonia

10%

Wheezing

10%

Urinary tract infection

10%

Aspartate aminotransferase increased

10%

Blood creatinine increased

10%

Alanine aminotransferase increased

10%

Lymphocyte count decreased

10%

Anxiety

10%

Depression

10%

Rash maculo-papular

10%

Erythema

10%

Atrial fibrillation

10%

Overdose

10%

Haemorrhoidal haemorrhage

10%

Pleural effusion

10%

Oropharyngeal pain

10%

Productive cough

10%

Non-cardiac chest pain

10%

Chest pain

10%

Dehydration

10%

Hypokalaemia

10%

Hypophosphataemia

10%

Pain of skin

10%

Haemorrhoids

10%

Gait disturbance

10%

Neuropathy peripheral

10%

Hypothyroidism

10%

Vision blurred

10%

Proctalgia

Asthenia

Nasal congestion

Intestinal obstruction

Pyrexia

Dysphonia

Pneumonitis

Toxicity to various agents

Lactic acidosis

Hyponatraemia

Hypomagnesaemia

Dizziness

Headache

Lethargy

Pain in extremity

Tachycardia

Hypotension

Cardiac arrest

Candida infection

Hyperhidrosis

Sinus tachycardia

Fall

Contusion

Abdominal pain

Gastrooesophageal reflux disease

Pulmonary embolism

Sepsis

Diverticulitis

Pericardial effusion

Angina pectoris

Cancer pain

Neuroendocrine carcinoma of the skin

Haematochezia

Malaise

Amylase increased

Peripheral sensory neuropathy

Syncope

Hyperglycaemia

Hepatic enzyme increased

Lipase increased

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Stage 1 (Cohort 2): Niraparib + Pembrolizumab

Stage 2 (Cohort 1A): Niraparib + TSR-042 (Dostarlimab)

Stage 2 (Cohort 2A): Niraparib + TSR-042 (Dostarlimab)

Stage 1 (Cohort 1): Niraparib + Pembrolizumab

Stage 1 (Cohort 3): Niraparib

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

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

Trial Design

9Treatment groups

Experimental Treatment

Group I: Participants receiving dostarlimab plus belrestotug plus nelistotug (Arm F)Experimental Treatment3 Interventions

Group II: Participants receiving dostarlimab plus belrestotug plus GSK4381562 (Arm E)Experimental Treatment3 Interventions

Group III: Participants receiving dostarlimab plus belrestotug (Arm D)Experimental Treatment2 Interventions

Group IV: Participants receiving GSK5764227 plus dostarlimab (Arm I)Experimental Treatment2 Interventions

Group V: Participants receiving GSK4381562 plus dostarlimab plus belrestotug (Arm C)Experimental Treatment3 Interventions

Group VI: Participants receiving GSK4381562 plus dostarlimab (Arm B)Experimental Treatment2 Interventions

Group VII: Participants receiving GSK4381562 monotherapy (Arm A)Experimental Treatment1 Intervention

Group VIII: China Cohort: Participants receiving dostarlimab plus belrestotug (Arm H)Experimental Treatment2 Interventions

Group IX: China Cohort: Participants receiving dostarlimab (Arm G)Experimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dostarlimab

FDA approved

0 / 8Eligibility 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 include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but can also affect healthy cells, leading to side effects. Targeted therapy, such as tyrosine kinase inhibitors, specifically targets molecular abnormalities in cancer cells, thereby minimizing damage to normal cells. Immunotherapy, including immune checkpoint inhibitors, enhances the body's immune response against cancer cells. Understanding these mechanisms is crucial for patients as it helps them comprehend how treatments work, potential side effects, and the rationale behind choosing a specific therapy, which can improve their engagement and adherence to treatment plans.