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?

This trial tests a new drug, KQB168, alone or with pembrolizumab (an immunotherapy), to determine if they can shrink advanced solid tumors in adults. Researchers aim to find a safe dose and understand how KQB168 behaves in the body. The trial seeks individuals whose solid tumors have spread or cannot be surgically removed and have not responded to other treatments. Participants will take KQB168 daily and visit the clinic frequently, especially during the first two months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, and participants will be among the first to receive this new drug.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found pembrolizumab to be generally well-tolerated. The FDA has approved it for treating certain types of cancers, indicating its safety for those conditions. However, individual experiences may vary.

For KQB168, less information is available. This treatment remains in early testing stages, with its safety under study. Early trials like this one help researchers understand how the treatment interacts with the body and what side effects might occur. Since KQB168 is in a Phase 1 trial, researchers are still collecting and refining safety information.

Participants in this study will help determine if KQB168 alone, or with pembrolizumab, is safe and effective for treating solid tumors. Researchers will closely monitor safety throughout the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for solid tumor cancers, which often rely on chemotherapy or radiation, KQB168 is an oral medication that works differently by targeting specific pathways within cancer cells. Researchers are excited about KQB168 because it offers a novel mechanism of action that could potentially enhance the effectiveness of existing therapies like pembrolizumab. Additionally, the combination of KQB168 with pembrolizumab, an established immunotherapy, may improve patient outcomes by boosting the immune system's ability to fight cancer more effectively. This innovative approach could provide a more targeted and less invasive treatment option for patients.

What evidence suggests that this trial's treatments could be effective for solid tumor cancers?

Research has shown that pembrolizumab effectively treats several types of cancer by enhancing the immune system's ability to attack cancer cells. In this trial, KQB168 is being tested as a new treatment to determine if it can shrink tumors in individuals with advanced solid tumor cancers. Although data on KQB168 remains limited, scientists remain hopeful because it targets specific processes that aid cancer cell growth. This trial includes a treatment arm combining KQB168 with pembrolizumab to assess whether it can further boost the immune response. Early findings appear promising, but further research is necessary to confirm its effectiveness. ^{1 2 4 5 6}

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06994806

A Study to Investigate the Safety and Efficacy of KQB168 ... 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 ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06994806?term=KQB168%20&rank=1

A Study to Investigate the Safety and Efficacy of KQB168 ... 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 ...

3. trial.medpath.com trial.medpath.com/clinical-trial/590560d090b32fef/nct06994806-kqb168-pembrolizumab-advanced-solid-malignancies

A Study to Investigate the Safety and Efficacy of KQB168 as ... 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.

4. yalemedicine.org yalemedicine.org/clinical-trials/a-study-to-investigate-the-safety-and-efficacy-of-kqb168-as-monotherapy-and-in-combination-in-partic

A Phase 1, Open-label, Multicenter, Dose Escalation Study ... 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 ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT06994806

A Study to Investigate the Safety and Efficacy of KQB168 ... A Study to Investigate the Safety and Efficacy of KQB168 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies. P1. Kumquat ...

6. cancer.gov cancer.gov/clinicaltrials/NCI-2025-04317

A Study to Investigate the Safety and Efficacy of KQB168 ... 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.