KVA12123 + Pembrolizumab for Cancer

Recruiting at 5 trial locations

Overseen By Shawn Iadonato, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Kineta Inc.

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS metastases, Cardiovascular disease, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

314 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Thierry Guillaudeux, PhD

Principal Investigator

Kineta Inc.

Eligibility Criteria

Adults with advanced solid tumors that have worsened or didn't respond to standard treatments can join this trial. They must be in relatively good health, able to follow the study plan, and not pregnant. People with certain infections like HIV or hepatitis B/C can join if their condition is under control. Those who've had recent cancer treatments or major surgeries, active lung disease, severe allergies, or are on high-dose steroids cannot participate.

Inclusion Criteria

I finished curative radiation 2 weeks ago or palliative radiation for non-brain issues 1 week ago.

I am 18 years old or older.

My organs are functioning well enough for treatment.

Exclusion Criteria

I have had lung inflammation that needed steroids or have it now.

Inability to comply with study procedures

You are allergic to any of the ingredients in the KVA12123 drug.

Treatment Details

Interventions

• KVA12123 Treatment
• Pembrolizumab

Trial Overview The trial tests KVA12123 alone and combined with Pembrolizumab for safety and proper dosage against various advanced cancers. Participants will receive KVA12123 every two weeks and Pembrolizumab every six weeks while undergoing regular scans, blood tests, physical exams, and heart function tests to monitor treatment effects.

Participant Groups

Group I: KVA12123 Plus Pembrolizumab Dose Expansion Experimental Treatment 1 Intervention

Part D will consist of dose expansion with KVA12123 administered at the RP2D in combination with a fixed dose of pembrolizumab.

Group II: KVA12123 Plus Pembrolizumab Dose Escalation Experimental Treatment 1 Intervention

Part B will consist of dose escalation with KVA12123 administered in combination with a fixed dose of pembrolizumab.

Group III: KVA12123 Monotherapy Dose Expansion Experimental Treatment 1 Intervention

Part C will consist of dose expansion with KVA12123 administered as a single agent at the RP2D in participants with advanced solid tumors.

Group IV: KVA12123 Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Part A will consist of dose escalation with KVA12123 administered as a single agent in participants with advanced solid tumors.

Who Is Running the Clinical Trial?

Kineta Inc.

Lead Sponsor

Trials

4

Recruited

390+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University