KQB168 + Pembrolizumab for Solid Tumor Cancers

Recruiting at 3 trial locations

Overseen By Kumquat Clinical Development

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Kumquat Biosciences Inc.

Disqualifiers: CNS tumors, Cardiac abnormalities, Lung diseases, others

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

Compensation: Varies

Number of Visits: 8

Duration: 8 weeks initial intensive phase, then every 3 weeks

84 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to learn if KQB168 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB168. The main questions it aims to answer are: * What is the safe dose of KQB168 by itself or in combination with pembrolizumab? * Does KQB168 alone or in combination with pembrolizumab decrease the size of the tumor? * What happens to KQB168 in the body? Participants will: * Take KQB168 daily, alone or in combination with pembrolizumab * Visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that

Are You a Good Fit for This Trial?

Adults with advanced solid tumors, including uterine tumors, that have worsened after immunotherapy can join. They should have a confirmed diagnosis, measurable disease by RECIST v1.1 standards, and good organ function. Those without curative treatment options are eligible.

Inclusion Criteria

There are no treatments that can cure my condition.

Measurable disease per RECIST v1.1

My organs are working well.

Exclusion Criteria

I have a history of lung diseases.

I have heart problems.

I have an active brain tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take KQB168 daily, alone or in combination with pembrolizumab

8 weeks initial intensive phase, then every 3 weeks

8 visits in the first 8 weeks, then once every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• KQB168
• Pembrolizumab

Trial Overview The trial is testing KQB168's effectiveness and safety in treating solid tumor cancers when taken alone or with Pembrolizumab. It aims to find the safe dose of KQB168, its impact on tumor size, and how it behaves in the body.

How Is the Trial Designed?

Group I: Monotherapy Dose Escalation Experimental Treatment 1 Intervention

Drug: KQB168 - Oral KQB168

Group II: Combo Therapy Dose Escalation Experimental Treatment 2 Interventions

Drug: KQB168 - Oral KQB168 Drug: pembrolizumab - Intravenous pembrolizumab

Who Is Running the Clinical Trial?

Kumquat Biosciences Inc.

Lead Sponsor

Trials

3

Recruited

350+