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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 belowSelect...
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:Select...
I have had a bone marrow or organ transplant.
Select...
I had severe side effects from cancer treatment that stopped my therapy or have ongoing side effects.
Select...
I do not have uncontrolled brain metastases or cancer in the lining of my brain.
Select...
I have not received a live vaccine in the last 30 days.
Select...
I have an autoimmune disease treated with strong medication in the last 2 years.
Select...
I am on medication that weakens my immune system.
Select...
I have a history of serious lung conditions that needed steroids.
Select...
I have not had major surgery within the last 4 weeks.
Select...
I have a history of serious heart problems.
Select...
I do not have an active infection needing treatment, HIV, or hepatitis B/C.
Select...
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
Treatment Details
Side effects data
From 2021 Phase 2 trial • 53 Patients • NCT0330894257%
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
5%
Asthenia
5%
Nasal congestion
5%
Dysphonia
5%
Intestinal obstruction
5%
Pyrexia
5%
Pneumonitis
5%
Toxicity to various agents
5%
Lactic acidosis
5%
Hyponatraemia
5%
Hypomagnesaemia
5%
Dizziness
5%
Headache
5%
Lethargy
5%
Pain in extremity
5%
Tachycardia
5%
Hypotension
5%
Cardiac arrest
5%
Candida infection
5%
Hyperhidrosis
5%
Sinus tachycardia
5%
Fall
5%
Contusion
5%
Abdominal pain
5%
Gastrooesophageal reflux disease
5%
Pulmonary embolism
5%
Sepsis
5%
Diverticulitis
5%
Pericardial effusion
5%
Angina pectoris
5%
Cancer pain
5%
Neuroendocrine carcinoma of the skin
5%
Haematochezia
5%
Malaise
5%
Amylase increased
5%
Peripheral sensory neuropathy
5%
Syncope
5%
Hyperglycaemia
5%
Hepatic enzyme increased
5%
Lipase increased
5%
Respiratory failure
100%
80%
60%
40%
20%
0%
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
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.
Current trends and future directions in the genetic therapy of human neoplastic disease.Glufosfamide: can we improve the process of anticancer agent development?
Current trends and future directions in the genetic therapy of human neoplastic disease.Glufosfamide: can we improve the process of anticancer agent development?
Find a Location
Who is running the clinical trial?
iTeos TherapeuticsIndustry Sponsor
10 Previous Clinical Trials
2,355 Total Patients Enrolled
GlaxoSmithKlineLead Sponsor
4,813 Previous Clinical Trials
8,382,392 Total Patients Enrolled
5 Trials studying Tumors
1,919 Patients Enrolled for Tumors
23andMe, Inc.Industry Sponsor
9 Previous Clinical Trials
83,610 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a history of drug or alcohol abuse.I have had a bone marrow or organ transplant.I am fully active or restricted in physically strenuous activity but can do light work.I haven't had cancer treatment or experimental drugs in the last 4 weeks.I had severe side effects from cancer treatment that stopped my therapy or have ongoing side effects.I do not have uncontrolled brain metastases or cancer in the lining of my brain.I haven't had allergen desensitization therapy in the last 4 weeks.I haven't received blood products or colony-stimulating factors in the last 14 days.I have not received a live vaccine in the last 30 days.You have had an allergic reaction to any of the study treatments or their ingredients.I agree to use effective birth control if I can have children.I have had another cancer that got worse or needed treatment in the last 2 years.I have an autoimmune disease treated with strong medication in the last 2 years.I am on medication that weakens my immune system.I have had fluid build-up in my abdomen or chest that was not controlled in the last 6 months.My cancer is advanced, has come back, or has spread to other parts.My organ functions are within normal ranges according to recent tests.I have a history of serious lung conditions that needed steroids.I am at least 18 years old, or 20 if participating in certain Japan arms.I have not had major surgery within the last 4 weeks.I have a history of serious heart problems.I do not have an active infection needing treatment, HIV, or hepatitis B/C.My liver is not stable or I have cirrhosis, as assessed by my doctor.My cancer has worsened after standard treatment or standard treatment was not suitable for me.I can provide a fresh sample of my tumor for the study.You are expected to live for at least 3 months (12 weeks).
Research Study Groups:
This trial has the following groups:- Group 1: Participants receiving dostarlimab plus belrestotug (Arm E)
- Group 2: Participants receiving dostarlimab plus cobolimab (Arm G)
- Group 3: Participants receiving dostarlimab plus belrestotug plus GSK6097608 (Arm F)
- Group 4: Participants receiving dostarlimab monotherapy (Arm D)
- Group 5: Participants receiving GSK6097608 monotherapy (Arm A)
- Group 6: Participants receiving GSK6097608 plus dostarlimab (Arm B)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.