Trials / Unknown

UnknownNCT05708950

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

Status: Unknown
Phase: Phase 1 / Phase 2
Study type: Interventional
Enrollment: 314 (estimated)

Sponsor: Kineta Inc. · Industry
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

This is a first-in-human (FIH), Phase 1/2, open-label, multicenter, dose escalation, and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, and tumor response of the investigational drug KVA12123 alone and in combination with pembrolizumab in adults with relapsed or refractory advanced solid tumors. The study will be conducted in 4 parts: Parts A and B will focus on dose escalation (single-agent and in combination), and Parts C and D will focus on dose expansion (single-agent and in combination). Parts A (single-agent KVA12123) and B (KVA12123 + pembrolizumab) will comprise up to 10 dose escalation cohorts (6 for Part A and 4 for Part B) and treat 1-6 participants in each cohort to characterize the safety, tolerability, pharmacodynamics (PD), pharmacokinetics (PK) and preliminary tumor responses of study interventions. The objective of Parts A and B will be to determine a recommended Phase 2 dose (RP2D) for Parts C and D. Parts C (single-agent KVA12123) and D (KVA12123 + pembrolizumab) will comprise up to 7 disease-specific dose expansion cohorts (2 for Part C and 5 for Part D), which will commence at the RP2D to further characterize the safety, tolerability, PD, PK, and preliminary tumor response of KVA12123 alone and in combination with pembrolizumab.

Conditions

Interventions

Type	Name	Description
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.

Timeline

Start date: 2023-03-03
Primary completion: 2024-06-30
Completion: 2024-12-31
First posted: 2023-02-01
Last updated: 2023-07-13

Locations

6 sites across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT05708950. Inclusion in this directory is not an endorsement.