A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In … (NCT05708950) | Clinical Trial Compass
CompletedPhase 1/2
A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)
United States40 participantsStarted 2023-03-03
Plain-language summary
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. The main questions this study aims to answer are:
1. What is the safety of KVA12123 when administered alone and in combination with pembrolizumab to advanced cancer patients?
2. What is an appropriate dose of KVA12123 to administer alone and in combination with pembrolizumab to advanced cancer patients in future clinical trials?
Participants in this trial will be asked to:
1. Visit the clinical site every 1 - 2 weeks.
2. Receive KVA12123 every 2 weeks alone or in combination with pembrolizumab every 6 weeks.
3. Provide blood samples to evaluate drug levels in blood, drug safety and to explore the effects of each drug on the immune system.
4. Undergo scans every 6 weeks to test the effect of treatment on cancer progression.
5. Undergo other study procedures to evaluate drug safety and participant safety including physical exams, heart function tests, etc.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Willing and able to provide informed consent.
. Be at least 18 years of age at the time of consent.
. Has histologically or cytologically confirmed, locally advanced or metastatic solid tumor that has progressed or was non-responsive to standard of care therapy and for which no available curative therapy exists.
. Has expected survival ≥16 weeks.
. Presence of measurable disease by iRECIST.
. Has an ECOG performance status score of 0 or 1.
. Has adequate organ function within 10 days prior to the start of study treatment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as completed — does that mean the results are available yet, and if so, what did they find about the safety and dosing of KVA12123, either alone or combined with pembrolizumab?
2Since this was a Phase 1/2 trial primarily focused on finding a safe dose and identifying side effects, what does that mean for how much we actually know about whether KVA12123 works for my specific cancer type?
3The trial covered a very wide range of cancer types, including mine — do you know whether any of the safety or early effectiveness signals from this study were stronger for my particular cancer, and how might that affect my options going forward?
4Pembrolizumab is already an approved immunotherapy — can you help me understand how adding an experimental drug like KVA12123 to it might change the risk profile compared to pembrolizumab alone, based on what this trial reported?
5Now that this trial is completed, are there any follow-on studies or next-phase trials building on these results that might be worth considering as a next step to discuss with you?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Adverse Events
Timeframe: Through study completion, an average of 1 year
2
AEs related to study drug
Timeframe: Through study completion, an average of 1 year
3
Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD)
Timeframe: Through study completion, an average of 1 year
. Has normal thyroid function or hypothyroid with stable supplementation.
Exclusion criteria
. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression.
. Concurrent cancer other than disease under study requiring systemic treatment. Participants with basal cell or squamous cell skin cancer treated with curative intent, carcinoma in-situ of the cervix or breast treated with curative intent, RAI stage 0 Chronic Lymphocytic Leukemia, monoclonal gammopathy of undetermined significance, superficial bladder cancer or very low and low risk prostate cancer (localized Gleason score ≤ 6) under active surveillance are eligible.
. Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg QD of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
. History of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or current pneumonitis/ILD.
. Prior treatment with VISTA-targeted therapy.
. Prior history of allogeneic, solid organ or stem cell transplant, or adoptive T-cell transplant.
. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, LAG-3, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE).