RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-03-03
Study Completion:2024-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05708950

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Thierry Guillaudeux, PhD
CONTACT
888-530-2655
tguillaudeux@kineta.us
Shawn Iadonato, PhD
CONTACT
888-530-2655
siadonato@kineta.us

Principal Investigator

Thierry Guillaudeux, PhD
STUDY_DIRECTOR
Kineta Inc.

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Kineta Inc.

  • Thierry Guillaudeux, PhD, STUDY_DIRECTOR, Kineta Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-03
Study Completion Date2024-12-31

Study Record Updates

Study Start Date2023-03-03
Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • 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