KVA12123 + Pembrolizumab for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the safety and effectiveness of a new cancer treatment, KVA12123, both alone and with pembrolizumab, in individuals with advanced solid tumors. Researchers aim to determine if KVA12123 is safe to use by itself or with pembrolizumab and to establish the appropriate dose for future studies. Ideal participants are those with advanced solid tumors that have not responded to standard treatments. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I have to stop taking my current medications to join the trial?
The trial requires a 'washout period' (time without taking certain medications) for participants who have had prior systemic anticancer therapy. This means you may need to stop taking some medications for 2 to 4 weeks before starting the trial, depending on the type of medication.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that KVA12123 is generally well-tolerated when used alone. Early results indicate it is safe at doses of 3, 10, and 30 mg for patients with advanced solid tumors, with most patients not experiencing severe side effects.
When combined with pembrolizumab, KVA12123 also shows positive safety results. Initial studies suggest this combination is well-tolerated. However, as this is an early-stage trial, researchers continue to monitor for any possible side effects to determine the safest and most effective dose.
Overall, both KVA12123 alone and with pembrolizumab appear safe. Trial participants will be monitored carefully to ensure their safety.12345Why are researchers excited about this trial's treatments?
KVA12123 is unique because it offers a new approach for treating advanced solid tumors. Unlike current standards of care that often rely on chemotherapy or radiation, KVA12123 targets cancer cells with a novel mechanism thought to enhance the immune response. When combined with pembrolizumab, a well-known checkpoint inhibitor, it potentially boosts the immune system's ability to fight cancer more effectively. Researchers are excited because this combination could significantly improve outcomes by leveraging both drugs' strengths to attack tumors more aggressively and precisely.
What evidence suggests that this trial's treatments could be effective for advanced solid tumors?
Research shows that KVA12123, a type of antibody, has produced promising results against tumors in early tests. In this trial, some participants will receive KVA12123 as a monotherapy, which performed well in animal studies. Other participants will receive KVA12123 combined with pembrolizumab, a well-known cancer drug, which yielded even better results in animal studies. Initial studies in humans indicate that KVA12123 is generally safe and does not cause severe side effects at the doses tested. When used with pembrolizumab, early signs suggest it could effectively target and treat advanced solid tumors. While more research is needed, these early findings encourage its potential use in cancer treatment.23567
Who Is on the Research Team?
Thierry Guillaudeux, PhD
Principal Investigator
Kineta Inc.
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive KVA12123 alone or in combination with pembrolizumab to determine the recommended Phase 2 dose
Dose Expansion
Participants receive KVA12123 at the recommended Phase 2 dose alone or in combination with pembrolizumab to further evaluate safety and efficacy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- KVA12123 Treatment
- Pembrolizumab
Trial Overview
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.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Part D will consist of dose expansion with KVA12123 administered at the RP2D in combination with a fixed dose of pembrolizumab.
Part B will consist of dose escalation with KVA12123 administered in combination with a fixed dose of pembrolizumab.
Part C will consist of dose expansion with KVA12123 administered as a single agent at the RP2D in participants with advanced solid tumors.
Part A will consist of dose escalation with KVA12123 administered as a single agent in participants with advanced solid tumors.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Kineta Inc.
Lead Sponsor
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
Citations
1.
aacrjournals.org
aacrjournals.org/cancerres/article/85/8_Supplement_2/CT041/761759/Abstract-CT041-Initial-results-from-a-first-inInitial results from a first in human phase 1 study of KVA12123 ...
A first in human phase 1 study of KVA12123, an anti-VISTA antibody, alone and in combination with pembrolizumab in patients with advanced solid tumors.
NCT05708950 | A Clinical Trial of KVA12123 Treatment ...
The goal of this clinical trial is to test the safety and efficacy of KVA12123 alone or combined with pembrolizumab in patients with advanced solid tumors.
3.
targetedonc.com
targetedonc.com/view/kva12123-appears-well-tolerated-in-advanced-solid-tumors-across-3-dosesKVA12123 Appears Well-Tolerated in Advanced Solid ...
Across the first 3 cleared monotherapy cohorts, KVA12123 was well-tolerated with no dose-limiting toxicities observed.
A highly potent anti-VISTA antibody KVA12123 - PMC
KVA12123 treatment mediated strong single-agent antitumor activity in several syngeneic tumor models and showed enhanced efficacy in ...
Kineta Updates KVA12123 Clinical Results from Ongoing ...
KVA12123 cleared all six monotherapy dose levels and the second of four cohorts in combination with pembrolizumab. KVA12123 was well tolerated ...
625 A phase 1/2 clinical trial of antiVISTA – KVA12123 ...
625 A phase 1/2 clinical trial of antiVISTA – KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors.
KVA12123 Showcases Early Tolerability in Advanced Solid ...
KVA12123 demonstrated early signals of on-target activity and tolerability at all dose levels examined to date in patients with advanced solid tumors.
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