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

NCT05708950 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 314

Last updated 2023-07-13

No results posted yet for this study

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.

Conditions

Interventions

DRUG

KVA12123 - Dose Escalation

Ascending KVA12123 doses given as monotherapy by intravenous administration every 2 weeks of each 6-week cycle.

DRUG

KVA12123 Plus Pembrolizumab - Dose Escalation

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.

DRUG

KVA12123 - Dose Expansion

KVA12123 administered at the RP2D by intravenous administration every 2 weeks of each 6 week cycle.

DRUG

KVA12123 Plus Pembrolizumab - Dose Expansion

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.

Sponsors & Collaborators

Principal Investigators

  • Thierry Guillaudeux, PhD · Kineta Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-03
Primary Completion
2024-06-30
Completion
2024-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05708950 on ClinicalTrials.gov