120 Participants Needed

Q702 + Pembrolizumab for Advanced Solid Cancers

Recruiting at 11 trial locations
QC
Overseen ByQurient Clinical Trial Information
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of two treatments: Q702 (an experimental treatment) and pembrolizumab (an immunotherapy drug) for certain advanced cancers, including esophageal, gastric, liver (hepatocellular), and cervical cancers. The goal is to determine the safety and effectiveness of this combination for patients whose cancer has not responded to previous treatments. The trial consists of two parts: one to identify the best dose of Q702 and another to evaluate the combination's effectiveness. Suitable candidates have one of these cancers and have already tried other treatments without success. As a Phase 1, Phase 2 trial, this study aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering patients a chance to be among the first to benefit from this new approach.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that strongly affect specific liver enzymes (CYP1A2, 2J2, 2C19, 2D6, and 3A4/5) and sensitive medications processed by CYP2C9, 2C19, and 3A4. You must stop these medications for a period of five half-lives (a measure of time it takes for a drug's concentration to reduce by half) before starting the study and throughout the trial.

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

In a previous study, researchers found that using Q702 with pembrolizumab is generally safe, as most patients did not experience severe side effects. Reports indicated that patients tolerated the treatment well. Pembrolizumab, one of the drugs in this study, has FDA approval for treating other types of cancer, confirming its safety for those uses. Overall, early research suggests that this combination of treatments is generally safe for patients.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Q702 and pembrolizumab for advanced solid cancers because this duo offers a fresh approach to treatment. Unlike traditional therapies that often focus solely on attacking cancer cells directly, Q702 works by modulating the immune system to enhance its natural ability to fight cancer. When paired with pembrolizumab, an established immunotherapy that blocks a protein called PD-1 to boost immune response, this combination has the potential to improve effectiveness and outcomes for patients. This innovative strategy could lead to more precise and powerful treatment options for those battling advanced cancers.

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

Research has shown that pembrolizumab effectively treats various solid tumors, such as non-small cell lung cancer and melanoma, by helping patients live longer. It enables the immune system to find and attack cancer cells. In this trial, participants will receive a combination of Q702 and pembrolizumab. Studies have found that Q702 targets certain proteins to boost the immune response and make tumors more responsive to treatments, working well with pembrolizumab. Early data suggests that using Q702 with pembrolizumab is safe and may benefit patients with advanced solid cancers. This combination aims to restore immune function and enhance the effects of immunotherapy.12345

Are You a Good Fit for This Trial?

This trial is for adults with advanced esophageal, gastric/GEJ, hepatocellular, or cervical cancers that worsened after anti-PD1/PD-L1 therapy. Participants must be able to consent, have measurable disease per RECIST v1.1., an ECOG status of 0 or 1, and a life expectancy over 3 months. Pregnant or breastfeeding women and those on certain drugs are excluded.

Inclusion Criteria

My cancer can be measured using standard imaging tests.
I am fully active or restricted in physically strenuous activity but can do light work.
The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.
See 2 more

Exclusion Criteria

I am not taking strong medication that affects enzyme activity in my body.
I am not taking any medications that interact with the study drug.
I have not had radiotherapy in the last 2 weeks or suffered from radiation pneumonitis.
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive Q702 in combination with pembrolizumab with a one week on/one week off schedule at selected dose level

Varies

Dose Expansion

Participants receive Q702 in combination with a fixed dose of pembrolizumab intravenously once every three weeks at 200 mg

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
  • Q702
Trial Overview The study tests the safety and early effectiveness of Q702 combined with pembrolizumab in selected cancer patients. It's an open-label phase 1B/2 trial where all participants receive the experimental drug combination to see how well it works.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Dose expansion of Q702 in combination with fixed dose of pembrolizumabExperimental Treatment2 Interventions
Group II: Dose escalation of Q702 in combination with fixed dose of pembrolizumabExperimental Treatment2 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Qurient Co., Ltd.

Lead Sponsor

Trials
10
Recruited
840+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

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 profile image

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

Published Research Related to This Trial

Pembrolizumab, a PD-1 inhibitor, has demonstrated clinical effectiveness in treating various solid tumors, particularly in patients with PD-L1-positive non-small-cell lung cancer and unresectable/metastatic melanoma.
Early-phase trials and ongoing studies are focused on further confirming the clinical benefits of pembrolizumab in thoracic malignancies, highlighting its potential as a significant treatment option in cancer therapy.
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions.Karim, S., Leighl, N.[2017]
Pembrolizumab (Keytruda) is the first anti-PD-1 therapy approved in the US for treating advanced malignant melanoma, specifically for patients who have progressed after prior treatments.
It is designed to target the PD-1 protein, enhancing the immune system's ability to fight cancer, and is currently under review for approval in the EU.
Pembrolizumab: first global approval.Poole, RM.[2021]
In a phase II trial involving 15 patients with resectable non-small cell lung cancer (NSCLC), neoadjuvant treatment with pembrolizumab showed a major pathologic response in 27% of patients, indicating promising antitumor activity before surgery.
The treatment was found to be feasible and safe, with only 33% of patients experiencing moderate adverse events, and no postoperative mortality, suggesting that pembrolizumab does not compromise surgical outcomes.
Neoadjuvant anti-programmed death-1 immunotherapy by pembrolizumab in resectable non-small cell lung cancer: First clinical experience.Eichhorn, F., Klotz, LV., Kriegsmann, M., et al.[2022]

Citations

A phase 1b/2, open-label study of selective Axl, Mer and ...The safety profile, pharmacokinetics (PK) and efficacy data for Q702 in combination with pembrolizumab are presented. Methods: QRNT-008 ( ...
Q702 : Axl/Mer/CSF1R Triple InhibitorBy selectively inhibiting Axl, Mer, and CSF1R, Q702 restores innate immune function and sensitizes tumors to both immunotherapy and chemotherapy. Preclinical ...
A phase 1b/2, open-label study of selective Axl, Mer and ...Preliminary data from QRNT-008 study showed that selective Axl/Mer/CSF1R inhibitor Q702 plus pembrolizumab has a manageable safety profile.
Q702 + Pembrolizumab for Advanced Solid CancersPembrolizumab has shown effectiveness in treating various solid tumors, including non-small cell lung cancer and melanoma, by improving survival rates compared ...
5.keytrudahcp.comkeytrudahcp.com/efficacy/
Efficacy Data for KEYTRUDA® (pembrolizumab)KEYTRUDA is indicated for the treatment of adult patients with resectable locally advanced HNSCC whose tumors express PD-L1 [Combined Positive Score (CPS) ≥1] ...
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