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KVA12123 + Pembrolizumab for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Kineta Inc.

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

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 more

Awards & 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.

0 / 25Eligibility criteria met

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Who is running the clinical trial?

Merck Sharp & Dohme LLCIndustry Sponsor

4,031 Previous Clinical Trials

5,189,390 Total Patients Enrolled

Kineta Inc.Lead Sponsor

3 Previous Clinical Trials

80 Total Patients Enrolled

Thierry Guillaudeux, PhDStudy DirectorKineta Inc.

Media Library

KVA12123 Treatment (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05708950 — Phase 1 & 2

Stomach Cancer Research Study Groups: KVA12123 Monotherapy Dose Expansion, KVA12123 Monotherapy Dose Escalation, KVA12123 Plus Pembrolizumab Dose Escalation, KVA12123 Plus Pembrolizumab Dose Expansion

Stomach Cancer Clinical Trial 2023: KVA12123 Treatment Highlights & Side Effects. Trial Name: NCT05708950 — Phase 1 & 2

KVA12123 Treatment (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05708950 — Phase 1 & 2

~114 spots leftby Dec 2025

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