VERT-002 for Solid Tumors

Recruiting at 21 trial locations

Overseen By Medical Officer

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Pierre Fabre Medicament

Must not be taking: Corticosteroids, others

Disqualifiers: CNS metastases, ILD, cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 4

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This clinical trial tests a new treatment called VERT-002 for individuals with certain advanced solid tumors, including non-small cell lung cancer. The main goals are to determine the safety of VERT-002, its effectiveness, and the optimal dose. This trial suits those with relapsed or hard-to-treat solid tumors and specific changes in the MET gene, identifiable through previous tests. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must not have taken a MET TKI within 7 days or any other systemic anticancer therapy within 14 to 28 days before starting the trial. It's best to discuss your current medications with the trial team to be sure.

Is there any evidence suggesting that VERT-002 is likely to be safe for humans?

Research has shown that VERT-002 has been tested in people with solid tumors, including non-small cell lung cancer. In these studies, researchers assess the treatment's safety and patient tolerance. The goal is to determine the optimal dose that works without causing excessive side effects.

Safety data from earlier trials indicate a focus on identifying a dose that is both safe and effective. Researchers test different dose levels to observe patient reactions, monitoring for any side effects or treatment reactions. Common side effects in early trials may include mild to moderate reactions, varying by individual and dose.

As this trial is in the early stages, it primarily focuses on understanding the safety of VERT-002. Researchers continue to gather information to ensure its safety for more patients. If the drug were already approved for another condition, its safety profile would be well-known, but in this case, the focus is on learning more about its safety for solid tumors. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid tumors, which often involve chemotherapy, radiation, or surgery, VERT-002 introduces a novel approach by targeting specific pathways within cancer cells. This experimental treatment is administered through an intravenous infusion, potentially allowing for more precise dosing and targeting of the tumor. Researchers are particularly excited about VERT-002 because it could offer a new mechanism of action that enhances effectiveness and minimizes side effects, which are common with traditional therapies.

What evidence suggests that VERT-002 might be an effective treatment for solid tumors?

Studies have shown that VERT-002 targets a specific process in the body often altered in solid tumors, such as non-small cell lung cancer. By blocking this process, the drug can inhibit cancer cell growth and division. Early research suggests that VERT-002 can shrink tumors in some patients, indicating its potential effectiveness. Although human studies have provided limited information, the drug's mechanism offers a strong basis for its expected benefits. These early results are promising for prospective trial participants, where VERT-002 will be administered in varying doses and schedules to assess its safety and effectiveness. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with advanced or widespread solid tumors, including non-small cell lung cancer, that have specific genetic changes known as MET alterations. Details on who can join are not fully provided.

Inclusion Criteria

My cancer has a specific genetic change (METex14 mutation) or one of several MET alterations.

My liver is working well.

My cancer has returned or didn't respond to treatment and has spread, with no standard treatment left.

Exclusion Criteria

I have not had major surgery within the last 14 days.

I do not have uncontrolled brain metastases or worsening spinal cord compression.

Uncontrolled intercurrent illness including psychiatric illness or social situation that would limit compliance with trial requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

VERT-002 administered via IV infusion every 2 weeks with 4 provisional doses planned

8 weeks

4 visits (in-person)

Preliminary Activity Assessment

One dose and schedule selected from Part 1 for further assessment

4-8 weeks

Dose Range Optimization

2 or 3 doses and schedule selected from Part 1 to determine OBD and MTD/MAD

4-8 weeks

Dose Expansion

Dose expansion at RP2D to be defined later

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VERT-002

Trial Overview The study is testing VERT-002 to find a safe and effective dose and see how well it works in treating certain types of cancers with genetic alterations.

How Is the Trial Designed?

Group I: VERT-002 (PFL-002) Experimental Treatment 1 Intervention

Part 1: Dose escalation (Phase Ia): VERT-002 will be administered via intravenous (IV) infusion every 2 weeks. 4 provisional doses are planned. An alternative regimen may be tested informed by the emerging data Part 2a: Preliminary Activity Assessment (Phase Ib): One dose \& schedule selected from Part 1 Part 2b: Dose range optimization (Phase Ib): 2 or 3 doses \& schedule selected from Part 1: From the lower limit \[Optimal Biologically Active Dose (OBD)\] \& upper limit \[Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) if MTD is not reached\] Part 3: Dose Expansion at RP2D (Phase II): To be defined later on

Who Is Running the Clinical Trial?

Pierre Fabre Medicament

Lead Sponsor

Trials

83

Recruited

90,400+

Marie-Andrée Gamache

Pierre Fabre Medicament

Chief Executive Officer

MBA from HEC Montréal

Dr. Núria Perez-Cullell

Pierre Fabre Medicament

Chief Medical Officer since 2022

PhD in Pharmacy from the University of Barcelona

Published Research Related to This Trial

The study found that two PPARbeta/delta ligands, GW0742 and GW501516, did not promote cancer cell growth or increase markers associated with tumorigenesis, such as Akt phosphorylation, VEGF, or COX2 expression, in various human cancer cell lines.

In vivo analysis in mice also showed no changes in liver, colon, or colon polyps after administration of these ligands, suggesting that PPARbeta/delta ligands do not enhance tumorigenesis, contradicting some previous reports.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peroxisome proliferator-activated receptor-beta/delta (PPARbeta/delta) ligands do not potentiate growth of human cancer cell lines. Hollingshead, HE., Killins, RL., Borland, MG., et al.[2022]

Vitamin D(3) and its analogs, along with PPARgamma ligands, have shown promising results as differentiating agents in the treatment of prostate cancer, highlighting their potential therapeutic roles.

Both classes of drugs target the vitamin D(3) receptor and PPARs, which are commonly expressed in prostate cancer cells, suggesting a mechanism of action that could enhance treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiating agents and the treatment of prostate cancer: Vitamin D3 and peroxisome proliferator-activated receptor gamma ligands. Leibowitz, SB., Kantoff, PW.[2019]

Activation of the PPARdelta receptor by selective agonists significantly stimulates the growth of breast and prostate cancer cell lines, indicating a potential role in cancer progression.

The study suggests that PPARdelta may promote cellular proliferation and angiogenesis through an autocrine loop involving increased expression of growth factors like VEGFalpha, highlighting the therapeutic potential of PPARdelta antagonists in treating these cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Activation of peroxisome proliferator-activated receptor delta stimulates the proliferation of human breast and prostate cancer cell lines. Stephen, RL., Gustafsson, MC., Jarvis, M., et al.[2019]

PPARdelta is consistently expressed in both normal and cancerous gastric tissues, indicating its potential role in gastric carcinogenesis, as shown through various methods including RT-PCR and immunohistochemistry.

The study found that inhibiting COX-2 with the specific inhibitor NS398 led to a reduction in PPARdelta expression in gastric cancer cells with high COX-2 levels, suggesting that COX-2 inhibitors may help prevent cancer by suppressing PPARdelta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expression of peroxisome proliferator-activated receptor delta in human gastric cancer and its response to specific COX-2 inhibitor. Yu, J., Leung, WK., Chen, J., et al.[2006]

In a study of 28 surgical sections of human chondrosarcoma, 67.9% of tumor cells showed positive immunoreaction for peroxisome proliferator-activated receptor-gamma (PPAR-gamma), indicating its potential role in the disease's development.

The PPAR-gamma ligands, particularly 15-deoxy-Delta(12,14)-prostaglandin J(2) (15d-PGJ(2)), were found to inhibit the proliferation of chondrosarcoma cells and induce apoptosis, suggesting they could be promising therapeutic agents for treating this type of cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibition of human chondrosarcoma cell growth via apoptosis by peroxisome proliferator-activated receptor-gamma. Nishida, K., Furumatsu, T., Takada, I., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06669117

Study Details | NCT06669117 | FIH Trial of VERT-002 in ... The goal of this clinical trial is to investigate the safety, the activity of VERT-002 (PFL-002), and the optimal safe dose to be used, in participants with ...

2. pierre-fabre.com pierre-fabre.com/en/news/phase-iii-pfl-002vert-first-patient

Dosing of the first patient in the phase I/II trial evaluating ... The PFL-002/VERT-002 phase I/II trial is an open label, multi-centre study that aims to assess the safety, tolerability, pharmacokinetics, ...

3. targetedonc.com targetedonc.com/view/fda-to-review-ind-of-pfl-002-vert-002-in-met-altered-nsclc

FDA to Review IND of PFL-002/VERT-002 in MET-Altered ... An international, multicenter, first-in-human, phase 1/2 study of PFL-002/VERT-002 plans to enroll patients with NSCLC with MET alterations.

4. synapse.patsnap.com synapse.patsnap.com/article/pierre-fabre-files-ind-for-pfl-002vert-002-for-solid-tumors-including-met-altered-nsclc

Pierre Fabre Files IND for PFL-002/VERT- ... This trial will focus on treating solid tumors, including non-small cell lung cancer (NSCLC). The upcoming PFL-002/VERT-002 Phase I/II trial is ...

5. clinicaltrials.eu clinicaltrials.eu/inn/vert-002/

VERT-002 – Application in Therapy and Current Clinical ... VERT-002 is an investigational drug currently being studied in clinical trials for patients with advanced solid tumors. It is specifically designed to target ...

6. jto.org jto.org/article/S1556-0864(25)02132-X/fulltext

P3.18.67 First-In-Human Phase I/II Trial of PFL-002/VERT ... The trial consists of 3 parts: In Part 1, patients with solid tumors, including NSCLC with MET alterations, will be enrolled to reach up to 30 evaluable ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155608642502132X

P3.18.67 First-In-Human Phase I/II Trial of PFL-002/VERT ... Around 2% to 4% of NSCLCs have MET exon 14 (METex14) skipping alterations, the median Overall Survival (OS) is 8 to 11 months without MET inhibitor treatment.

8. clinicaltrials.eu clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-vert-002-for-patients-with-advanced-solid-tumors-including-lung-cancer-with-met-alterations/

Study on the Safety and Effects of VERT-002 for Patients ... This study explores the safety and efficacy of VERT-002, a drug under investigation for the treatment of patients with advanced solid tumors, ...