The first patient with an advanced solid tumor has been dosed in part B of the phase 1/2 VISTA-101 trial (NCT05708950) of KVA12123 in combination pembrolizumab (Keytruda), according to Kineta, Inc.1
Part B of the study plans to assess NVA12123 in a combination and build on initial safety, tolerability, and pharmacokinetic data reported in part A of the trial, which evaluated KVA12123 as a monotherapy.
Initial data from the combination therapy arm, as well as additional monotherapy safety and efficacy findings, are expected to be reported in Q2 2024.
“Dosing the first patient in the combination arm with [pembrolizumab] and KVA12123 is a significant milestone for Kineta, and we are very pleased with the progress of our differentiated VISTA-blocking immunotherapy,” said Shawn Iadonato, PhD, chief executive officer of Kineta, in a press release.
KVA12123 is a VISTA-blocking immunotherapy which is currently being developed as a twice-weekly infusion. With unique epitope binding and an optimized IgG1 Fc region, KVA12123 has shown a strong monotherapy tumor growth inhibition in preclinical models and has not exhibited evidence of cytokine release syndrome in patients.
The safety, tolerability, pharmacokinetics, immunogenicity, and tumor response of KVA12123 as a monotherapy and combined with pembrolizumab are being evaluated in the open-label, multicenter, dose-escalation and dose-expansion phase 1/2 study for the treatment of patients with advanced solid tumors.2
The study consists of 4 parts. In phase 1, parts A and B will utilize a dose-escalation design to evaluate KVA12123 alone and with pembrolizumab and determine the recommended phase 2 dose for use in parts C and D. This portion of the trial has been initiated.
Then, the trial will transition into a phase 2 study with parts C and D which will focus on dose-expansion with an optimized dose determined in the first phase.
Patients aged 18 years and older with a histologically or cytologically confirmed, locally advanced or metastatic solid tumor that has progressed or was not responsive to standard of care therapy are eligible for enrollment in the trial. Patients must have an expected survival of ≥16 weeks, measurable disease, an ECOG performance status score of 0 or 1, adequate organ function, and normal thyroid function or hypothyroid with stable supplementation.
Type and frequency of adverse events and determining the maximum-tolerated dose are the primary end points of the study. Secondary end points include pharmacokinetics and investigator assessment of radiographic imaging according to iRECIST, including patients with progressive disease, stable disease, partial response, and complete response.
The trial is actively recruiting patients in Colorado, California, Florida, Michigan, Pennsylvania, and Tennessee, and has an estimated study completion date of December 31, 2024.2
KVA12123 may be an effective immunotherapy for a variety of cancer types, including non–small cell lung cancer, colorectal cancer, renal cell carcinoma, head and neck cancer, and ovarian cancer.
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About the Phase 1/2 VISTA-101 Trial
Trial Name: A Phase 1/2 Open-label Trial of KVA12123 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
ClinicalTrials.gov Identifier: NCT05708950
Sponsor: Kineta Inc.
Recruitment Contact: Thierry Guillaudeux, PhD, 888-530-2655, email@example.com
Completion Date: December 31, 2024
“We anticipate that the results from the combination arm will further build on the already encouraging initial safety, tolerability, and pharmacokinetic profile of KVA12123 observed in the monotherapy arm. We look forward to reporting initial clinical data for the combination treatment next year,” added Iadonato, in the press release.1
Kineta announces first patient dosed in phase 1/2 VISTA-101 clinical trial of KVA12123 in combination with KEYTRUDA® (pembrolizumab) in patients with advanced solid tumors. News release. Kineta, Inc. October 17, 2023. October 18, 2023. https://tinyurl.com/2p9rr5dk
A clinical trial of KVA12123 treatment alone and in combination with pembrolizumab on advanced solid tumors (VISTA-101). ClinicalTrials.gov. Updated July 13, 2023. Accessed October 17, 2023. https://tinyurl.com/2wd9u9b9