A Clinical Trial of KVA12123 Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)

Description

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.

Conditions

Cancer, Solid Tumor, Melanoma, Carcinoma, Sarcoma, Lung Cancer, Prostate Cancer, Breast Cancer, Colo-rectal Cancer, Uterine Cancer, Pancreatic Cancer, Gastric Cancer, Esophageal Cancer, Thyroid Cancer, Ovarian Cancer, Kidney Cancer, Head and Neck Cancer

Study Overview

Study Details

Study overview

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.

A Phase 1/2 Open-label Trial of KVA12123 Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors

A Clinical Trial of KVA12123 Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)

Condition
Cancer
Intervention / Treatment

-

Contacts and Locations

Santa Monica

UCLA Health (Santa Monica Cancer Care), Santa Monica, California, United States, 90404

Denver

Sarah Cannon Research Institute at HealthONE, Denver, Colorado, United States, 80218

Sarasota

Sarah Cannon Research Institute at Florida Cancer Specialists, Sarasota, Florida, United States, 34232

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

Philadelphia

Thomas Jefferson University, Philadelphia, Pennsylvania, United States, 19107

Nashville

Sarah Cannon Research Institute at Tennessee Oncology, Nashville, Tennessee, United States, 37203

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

    Ages Eligible for Study

    18 Years to

    Sexes Eligible for Study

    ALL

    Accepts Healthy Volunteers

    No

    Collaborators and Investigators

    Kineta Inc.,

    Thierry Guillaudeux, PhD, STUDY_DIRECTOR, Kineta Inc.

    Study Record Dates

    2024-12-31