What side effects are associated with this type of intervention?

Common treatments for tumors, particularly those involving immune checkpoint inhibitors like dostarlimab, often have side effects such as fatigue, rash, diarrhea, and immune-related adverse events like colitis, pneumonitis, and hepatitis. Targeted therapies, such as those involving belrestotug, may cause side effects including nausea, vomiting, fatigue, and specific organ toxicities depending on the target pathway. It is crucial for patients to be closely monitored for these side effects to manage them effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of tumors that target similar pathways to those being studied in the GSK6097608 trial. Immune checkpoint inhibitors like pembrolizumab (Keytruda) and nivolumab (Opdivo) target the PD-1 pathway and have been approved for various cancers, including melanoma, non-small cell lung cancer, and renal cell carcinoma. Tyrosine kinase inhibitors such as cabozantinib (Cabometyx) and lenvatinib (Lenvima) have been approved for the treatment of medullary thyroid cancer and other solid tumors. These drugs work by inhibiting specific pathways that promote tumor growth and survival.

What other types of research exist?

Promising novel alternatives to GSK6097608 for tumor patients include LY2090314, a GSK-3 inhibitor effective in neuroblastoma, and SR18662, a small molecule that inhibits colorectal cancer growth. Additionally, SK228, which reverses the epithelial-to-mesenchymal transition in breast cancer, shows potential as a chemotherapeutic agent.

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GSK6097608 + Dostarlimab for Advanced Cancers

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

Eastern cooperative oncology group (ECOG) performance status (PS) 0 to 1

Female participants of childbearing potential must agree to use a highly effective form of contraception

Must not have

Prior allogenic or autologous bone marrow transplantation or other solid organ transplantation

Toxicity from previous anticancer treatment, including; greater than or equal to (>=) Grade 3 immune-mediated toxicity considered related to prior immunotherapy and that led to treatment discontinuation; or toxicity related to prior treatment that has not resolved; or history of myocarditis of any grade during a previous treatment with immunotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests new drugs alone or in combination to treat people with advanced solid tumors. The drugs either attack cancer cells directly or help the immune system fight cancer. The study includes Japanese and Chinese participants.

Who is the study for?

Adults with advanced solid tumors who've tried standard treatments without success or can't tolerate them. They must be in good physical condition, have proper organ function, and for certain arms of the trial, provide fresh tumor biopsies. Women able to have children must use effective birth control. Exclusions include uncontrolled brain metastases, recent cancers besides the one being treated, active autoimmune diseases requiring treatment within 2 years, liver disease, infections like HIV/HBV/HCV, heart risks including QT prolongation on ECG.

What is being tested?

The study tests GSK6097608 alone and combined with dostarlimab against various solid tumors. Dostarlimab is also tested alone and with belrestotug or cobolimab in specific participant groups from Japan and China. The goal is to assess safety and effectiveness while monitoring how the body processes these drugs (pharmacokinetics) and their impact on the body (pharmacodynamics).

What are the potential side effects?

Potential side effects may include reactions at injection sites; symptoms related to immune system activation such as inflammation in different organs; fatigue; changes in blood counts affecting immunity or clotting; digestive issues like nausea or diarrhea; potential risk of infection due to immune modulation.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I agree to use effective birth control if I can have children.

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My cancer is advanced, has come back, or has spread to other parts.

Exclusion Criteria

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

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I have had a bone marrow or organ transplant.

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I had severe side effects from cancer treatment that stopped my therapy or have ongoing side effects.

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I do not have uncontrolled brain metastases or cancer in the lining of my brain.

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I have not received a live vaccine in the last 30 days.

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I have an autoimmune disease treated with strong medication in the last 2 years.

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I am on medication that weakens my immune system.

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I have a history of serious lung conditions that needed steroids.

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I have not had major surgery within the last 4 weeks.

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I have a history of serious heart problems.

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

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My liver is not stable or I have cirrhosis, as assessed by my doctor.

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

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

No Placebo-Only Group

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

Trial Design

6Treatment groups

Experimental Treatment

Group I: Participants receiving dostarlimab plus cobolimab (Arm G)Experimental Treatment2 Interventions

Participants will be administered an IV infusion of cobolimab followed by dostarlimab

Group II: Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)Experimental Treatment3 Interventions

Participants will be administered an IV infusion of dostarlimab followed by belrestotug followed by GSK6097608 every 3 weeks.

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

Participants will be administered IV infusions of dostarlimab followed by belrestotug, every 3 weeks.

Group IV: Participants receiving dostarlimab monotherapy (Arm D)Experimental Treatment1 Intervention

Participants will be administered an IV infusion of dostarlimab monotherapy (1 cohort will receive dostarlimab every 3 weeks and 1 cohort will receive dostarlimab every 6 weeks).

Group V: Participants receiving GSK6097608 plus dostarlimab (Arm B)Experimental Treatment2 Interventions

Participants will be administered IV infusion of GSK6097608 every 3 weeks in escalating doses followed by dostarlimab.

Group VI: Participants receiving GSK6097608 monotherapy (Arm A)Experimental Treatment1 Intervention

Participants will be administered an intravenous (IV) infusion of GSK6097608 every 3 weeks as monotherapy in escalating doses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cobolimab

2016

Completed Phase 3

~1590

GSK6097608

2019

Completed Phase 2

~180

Dostarlimab

2019

Completed Phase 3

~1940

0 / 14Eligibility 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 involves drugs designed to specifically target molecular abnormalities in cancer cells, thereby minimizing damage to normal cells. Immunotherapy, such as immune checkpoint inhibitors, enhances the body's immune system to recognize and attack cancer cells. Understanding these mechanisms is crucial for patients as it helps in making informed decisions about their treatment options, potential side effects, and the likelihood of treatment success. For investigational treatments like GSK6097608, which may involve novel mechanisms, this knowledge can provide insights into how new therapies might offer benefits over existing options.

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