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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be at least 18 years of age at the time of consent
Has consented to the collection of archival tissue prior to study treatment initiation
Must not have
History of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or current pneumonitis/ILD
Any condition requiring systemic treatment with corticosteroids or other immunosuppressive medications within 14 days before the first dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug to see if it's safe and effective in treating advanced solid tumors. Participants will visit the site regularly and receive treatments, with tests to check safety and cancer progression.
Who is the study for?
Adults with advanced solid tumors that have worsened or didn't respond to standard treatments can join this trial. They must be in relatively good health, able to follow the study plan, and not pregnant. People with certain infections like HIV or hepatitis B/C can join if their condition is under control. Those who've had recent cancer treatments or major surgeries, active lung disease, severe allergies, or are on high-dose steroids cannot participate.
What is being tested?
The trial tests KVA12123 alone and combined with Pembrolizumab for safety and proper dosage against various advanced cancers. Participants will receive KVA12123 every two weeks and Pembrolizumab every six weeks while undergoing regular scans, blood tests, physical exams, and heart function tests to monitor treatment effects.
What are the potential side effects?
Potential side effects include reactions at the injection site, fatigue, changes in blood counts leading to increased infection risk or bleeding problems. There may also be immune-related issues affecting organs like the lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies) among others.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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I have agreed to provide samples of my previous biopsy or surgery for the study.
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I am fully active or can carry out light work.
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My thyroid function is normal or I have stable hypothyroidism with treatment.
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I stopped taking targeted therapy or similar drugs 2 weeks ago.
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My advanced cancer did not respond to standard treatments and cannot be cured.
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I am HIV positive, on ART, and my HIV is well-controlled.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had lung inflammation that needed steroids or have it now.
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I haven't taken steroids or immunosuppressants in the last 14 days.
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I have brain metastases or spinal cord issues that haven't been treated.
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I have had a transplant or adoptive T-cell therapy in the past.
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I have previously been treated with VISTA-targeted therapy.
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I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.
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I need daily supplemental oxygen.
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I am HIV-positive and have had Kaposi sarcoma or Multicentric Castleman Disease.
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I do not have another cancer needing treatment besides the one being studied.
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I have been diagnosed with active or latent tuberculosis.
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I stopped a cancer treatment due to a severe side effect.
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I have an autoimmune disease treated in the last year.
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I had radiation therapy less than 2 weeks ago or have had lung inflammation from radiation.
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I have serious or uncontrolled heart problems.
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I have chronic hepatitis B or C.
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I am currently being treated for an infection.
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Side effects from my previous cancer treatments have not fully improved.
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I have not had a blood or platelet transfusion in the last 2 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AEs related to study drug
Adverse Events
Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD)
Secondary study objectives
Concentration of anti-KVA12123 antibodies in serum
Number of participants with complete response following treatment with KVA12123
Number of participants with complete response following treatment with KVA12123 plus pembrolizumab
+13 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Group I: KVA12123 Plus Pembrolizumab Dose ExpansionExperimental Treatment1 Intervention
Part D will consist of dose expansion with KVA12123 administered at the RP2D in combination with a fixed dose of pembrolizumab.
Group II: KVA12123 Plus Pembrolizumab Dose EscalationExperimental Treatment1 Intervention
Part B will consist of dose escalation with KVA12123 administered in combination with a fixed dose of pembrolizumab.
Group III: KVA12123 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Part C will consist of dose expansion with KVA12123 administered as a single agent at the RP2D in participants with advanced solid tumors.
Group IV: KVA12123 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Part A will consist of dose escalation with KVA12123 administered as a single agent in participants with advanced solid tumors.
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Who is running the clinical trial?
Merck Sharp & Dohme LLCIndustry Sponsor
4,004 Previous Clinical Trials
5,184,891 Total Patients Enrolled
Kineta Inc.Lead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled
Thierry Guillaudeux, PhDStudy DirectorKineta Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung inflammation that needed steroids or have it now.You are allergic to any of the ingredients in the KVA12123 drug.I have brain metastases or spinal cord issues that haven't been treated.I finished curative radiation 2 weeks ago or palliative radiation for non-brain issues 1 week ago.I haven't taken steroids or immunosuppressants in the last 14 days.I have had a transplant or adoptive T-cell therapy in the past.I have previously been treated with VISTA-targeted therapy.I have an immune system disorder or have been on high-dose steroids or other immune-weakening medicines recently.I haven't had cancer treatment or been in a cancer study in the last 4 weeks.I need daily supplemental oxygen.I am HIV-positive and have had Kaposi sarcoma or Multicentric Castleman Disease.You are pregnant, as confirmed by a urine test within 72 hours of starting the study drug.I am 18 years old or older.My organs are functioning well enough for treatment.I do not have another cancer needing treatment besides the one being studied.I have not had a live vaccine in the last 30 days.I have fully recovered from any major surgery I've had.I have agreed to provide samples of my previous biopsy or surgery for the study.I am a post-menopausal woman or I am surgically sterile.I have another cancer that is getting worse or was treated in the last 3 years.I have been diagnosed with active or latent tuberculosis.I am fully active or can carry out light work.My thyroid function is normal or I have stable hypothyroidism with treatment.I stopped a cancer treatment due to a severe side effect.I have an autoimmune disease treated in the last year.I had radiation therapy less than 2 weeks ago or have had lung inflammation from radiation.I've had lung radiation therapy of more than 30 Gy in the last 6 months.I have serious or uncontrolled heart problems.I have chronic hepatitis B or C.I am currently being treated for an infection.Side effects from my previous cancer treatments have not fully improved.I have not had a blood or platelet transfusion in the last 2 weeks.I stopped taking targeted therapy or similar drugs 2 weeks ago.My advanced cancer did not respond to standard treatments and cannot be cured.You are expected to live for at least 16 weeks.You have a disease that can be measured using a specific method called iRECIST.I have had cancer treatment before, but it's been over 4 weeks since my last dose.I am HIV positive, on ART, and my HIV is well-controlled.I had hepatitis B but no longer need treatment as my tests are clear.I had hepatitis C but it's now undetectable and I've completed treatment.
Research Study Groups:
This trial has the following groups:- Group 1: KVA12123 Monotherapy Dose Expansion
- Group 2: KVA12123 Monotherapy Dose Escalation
- Group 3: KVA12123 Plus Pembrolizumab Dose Escalation
- Group 4: KVA12123 Plus Pembrolizumab Dose Expansion
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.
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