A Clinical Trial of KVA12123 Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)
A Phase 1/2 Open-label Trial of KVA12123 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
2 other identifiers
interventional
314
1 country
6
Brief 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?
- 3.Visit the clinical site every 1 - 2 weeks.
- 4.Receive KVA12123 every 2 weeks alone or in combination with pembrolizumab every 6 weeks.
- 5.Provide blood samples to evaluate drug levels in blood, drug safety and to explore the effects of each drug on the immune system.
- 6.Undergo scans every 6 weeks to test the effect of treatment on cancer progression.
- 7.Undergo other study procedures to evaluate drug safety and participant safety including physical exams, heart function tests, etc.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 cancer
Started Mar 2023
Shorter than P25 for phase_1 cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 1, 2023
CompletedStudy Start
First participant enrolled
March 3, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedJuly 13, 2023
July 1, 2023
1.3 years
December 9, 2022
July 11, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Adverse Events
Type and frequency of adverse events as assessed by CTCAE v4.0.
Through study completion, an average of 1 year
AEs related to study drug
Type and frequency of treatment related adverse events as assessed by CTCAE v4.0.
Through study completion, an average of 1 year
Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD)
Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of KVA12123 when administered alone and in combination with pembrolizumab in participants with advanced solid tumors (milligrams or milligrams/kilogram).
Through study completion, an average of 1 year
Secondary Outcomes (16)
Pharmacokinetic (PK) profile of KVA12123 (Cmax)
Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Cmin)
Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (tmax)
Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (AUC)
Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (t1/2)
Through study completion, an average of 1 year
- +11 more secondary outcomes
Study Arms (4)
KVA12123 Monotherapy Dose Escalation
EXPERIMENTALPart A will consist of dose escalation with KVA12123 administered as a single agent in participants with advanced solid tumors.
KVA12123 Plus Pembrolizumab Dose Escalation
EXPERIMENTALPart B will consist of dose escalation with KVA12123 administered in combination with a fixed dose of pembrolizumab.
KVA12123 Monotherapy Dose Expansion
EXPERIMENTALPart C will consist of dose expansion with KVA12123 administered as a single agent at the RP2D in participants with advanced solid tumors.
KVA12123 Plus Pembrolizumab Dose Expansion
EXPERIMENTALPart D will consist of dose expansion with KVA12123 administered at the RP2D in combination with a fixed dose of pembrolizumab.
Interventions
Ascending KVA12123 doses given as monotherapy by intravenous administration every 2 weeks of each 6-week cycle.
Ascending KVA12123 doses given by intravenous administration every 2 weeks of each 6-week cycle in combination with a fixed dose of pembrolizumab administered once every 6 week cycle.
KVA12123 administered at the RP2D by intravenous administration every 2 weeks of each 6 week cycle.
KVA12123 administered at the RP2D by intravenous administration every 2 weeks in combination with a fixed dose of pembrolizumab administered once every 6 week cycle.
Eligibility Criteria
You may qualify if:
- 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.
- Has normal thyroid function or hypothyroid with stable supplementation.
- Has consented to the collection of archival tissue prior to study treatment initiation.
- Participants with prior exposure to systemic anticancer therapy including investigational agents following a 4-week washout period are eligible. Participants with prior small molecule targeted therapy or other short half-life drugs are eligible following a 2-week washout period.
- Participants having prior curative radiation therapy completed 2 weeks prior to study drug administration or prior palliative radiation therapy to non-CNS disease completed at least 1 week prior to study drug administration are eligible.
- HIV-infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease.
- Participants with a history of HBV infection having durable HBsAg loss and undetectable serum HBV DNA no longer requiring treatment are eligible.
- Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening and participants have completed curative antiviral therapy.
- Post-menopausal women and surgically sterile men and women are permitted.
- +10 more criteria
You may not qualify if:
- 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).
- Active known or suspected autoimmune disease that has required systemic treatment within the past year. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Prior systemic anticancer therapy, including investigational agents, within 4 weeks of treatment. Participants with prior small molecule targeted therapy or other short half-life drugs are eligible following a 2-week washout period.
- Has received prior radiation therapy within 2 weeks of start of study treatment or has a history of radiation pneumonitis.
- Has received radiation therapy to the lung that is \>30 Gy within 6 months of the first dose of study treatment.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- Any requirement for daily supplemental oxygen.
- Any condition requiring systemic treatment with corticosteroids (\>10 mg QD prednisone equivalents) or other immunosuppressive medications within 14 days before the first dose of study drug.
- +16 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kineta Inc.lead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (6)
UCLA Health (Santa Monica Cancer Care)
Santa Monica, California, 90404, United States
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218, United States
Sarah Cannon Research Institute at Florida Cancer Specialists
Sarasota, Florida, 34232, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Thierry Guillaudeux, PhD
Kineta Inc.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 9, 2022
First Posted
February 1, 2023
Study Start
March 3, 2023
Primary Completion
June 30, 2024
Study Completion
December 31, 2024
Last Updated
July 13, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share