Reqorsa + Pembrolizumab for Lung Cancer

(Acclaim-2 Trial)

Recruiting at 6 trial locations

Overseen By Sr Director, Clinical Operations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Genprex, Inc.

Must be taking: Pembrolizumab

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Autoimmune disease, Active infections, others

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

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 3

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new gene therapy (Reqorsa) combined with an existing cancer drug (pembrolizumab) in lung cancer patients who have previously benefited from pembrolizumab. The gene therapy delivers a tumor-suppressing gene, while pembrolizumab helps the immune system fight cancer.

Research Team

Daniel Morgensztern

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Adults over 18 with previously treated non-small cell lung cancer (NSCLC) who have had some benefit from prior treatments like pembrolizumab or chemotherapy, but whose disease has progressed. They must not be pregnant, agree to use contraception, and should not have serious health issues that could interfere with the trial.

Inclusion Criteria

For Phase 2, patients must have measurable disease per RECIST 1.1

My lung cancer is confirmed by lab tests and has spread.

I am fully active or can carry out light work.

Exclusion Criteria

I have an autoimmune disease.

I have not received a live-virus vaccine in the last month.

I had to stop or frequently change my pembrolizumab treatment because I couldn't tolerate it.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation (Phase 1)

Patients are enrolled in sequential cohorts treated with successively higher doses of quaratusugene ozeplasmid in combination with pembrolizumab to determine the recommended Phase 2 dose (RP2D).

First 21-day treatment cycle

1 visit per 21-day cycle

Dose Expansion (Phase 2)

Patients receive quaratusugene ozeplasmid at the RP2D in combination with pembrolizumab to better characterize safety and preliminary efficacy.

Approximately 8 months

1 visit per 21-day cycle

Randomized Treatment (Phase 2)

Patients are randomized to receive either the investigational treatment of quaratusugene ozeplasmid in combination with pembrolizumab or a control treatment of docetaxel +/- ramucirumab or the investigator's treatment of choice.

Approximately 8 months

1 visit per 21-day cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 11 months

Treatment Details

Interventions

• Docetaxel
• Pembrolizumab
• Ramucirumab Injection [Cyramza]
• Reqorsa (quaratusugene ozeplasmid)

Trial Overview The trial is testing quaratusugene ozeplasmid (Reqorsa), a gene therapy combined with pembrolizumab, against standard treatments. It's in two phases: first to find the right dose and then to check its safety and effectiveness compared to other options.

Participant Groups

Group I: Investigational Experimental Treatment 2 Interventions

In Phase 1, the dose expansion portion of Phase 2 and the investigational arm of the randomized portion of Phase 2, patients will receive their assigned dose of quaratusugene ozeplasmid (via intravenous infusion) in combination with a fixed 200 mg dose of pembrolizumab (via intravenous infusion) once in every 21-day treatment cycle until disease progression or unacceptable toxicity.

Group II: Control Active Control 3 Interventions

In the control arm of the randomized portion of Phase 2, patients will receive either 75 mg/m2 docetaxel (via intravenous infusion) with or without 10 mg/kg ramucirumab (via intravenous infusion) -OR- investigator's choice of treatment. The treatment regimen for patients randomized to the control arm, must begin at Cycle 1 Day 1 and continue every 21 days until disease progression or unacceptable toxicity.

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

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

Genprex, Inc.

Lead Sponsor

Trials

4

Recruited

250+