PM14 for Advanced Cancer

Recruiting at 8 trial locations

Overseen By Cristian Fernández, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: PharmaMar

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Uncontrolled hypertension, Active infection, HIV, others

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

Compensation: Varies

Number of Visits: 4

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called PM14 for individuals with advanced solid tumors that lack a cure. Researchers aim to discover better treatment options using PM14, administered through an IV (a tube into the vein). The trial seeks participants whose current cancer treatments have become ineffective or intolerable. Individuals with cancers such as certain gastrointestinal tumors, sarcomas, or specific types of breast, ovarian, or prostate cancer might be suitable candidates. 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 protocol does not specify if you must stop taking all current medications, but there are specific 'washout' periods (time without taking certain medications) for chemotherapy, monoclonal antibody therapies, and some hormonal therapies. If you have hormone-sensitive breast cancer, you must stop all hormonal therapies at least one week before starting the trial, except for certain medications. If you have castrate-resistant prostate cancer, you may continue hormone therapy during the trial.

Is there any evidence suggesting that PM14 is likely to be safe for humans?

Research has shown that PM14 is generally well-tolerated by patients with advanced solid tumors. One study found that PM14 had a manageable safety profile at recommended doses, indicating that while some side effects may occur, they are not severe or unexpected. Another study explores different administration methods for PM14 to enhance effectiveness without increasing side effects. Overall, PM14 appears to be a promising treatment option with acceptable safety for people with advanced cancer. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

PM14 is unique because it introduces a novel approach to treating advanced cancer through its innovative mechanism of action. Unlike traditional chemotherapy that targets rapidly dividing cells indiscriminately, PM14 specifically targets cancer cells with precision, potentially reducing harmful side effects. Researchers are excited about PM14 because it may offer a more effective and targeted treatment option for patients with advanced cancer, improving outcomes where existing therapies have limited success.

What evidence suggests that PM14 might be an effective treatment for advanced cancer?

Research has shown that PM14, the investigational treatment in this trial, may help treat advanced solid tumors. In an earlier study, patients who received PM14 experienced some positive responses, suggesting its potential effectiveness against these challenging cancers. Early trials tested various methods of administering PM14 to determine the best approach for managing side effects. Researchers believe PM14 could be effective because it targets cancer cells uniquely, unlike many current treatments. Although more research is needed, the initial results offer promise for people with advanced cancer. ^{1 3 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 with advanced solid tumors where no cure exists. It's specifically for those with certain gastrointestinal cancers, sarcomas, or tumors linked to BRCA mutations, among others. Participants should be in relatively good health (ECOG ≤1) and have had a limited number of prior chemotherapy treatments.

Inclusion Criteria

I am fully active and can carry on all my pre-disease activities without restriction.

My cancer can be measured by standard health scans.

Confirmed progressive disease after last therapy at study entry

Exclusion Criteria

I haven't taken specified medications in the last 6 months.

I am taking medication that could affect my heart rhythm.

I am currently being treated for an infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Patients receive PM14 at increasing dose levels to determine the maximum tolerated dose (MTD) and recommended dose (RD).

3 weeks per cycle

Visits on Day 1 and Day 8 of each cycle

Expansion

Patients are treated at the recommended dose to assess safety and antitumor activity.

Up to 9 cycles

Visits every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 72 months

What Are the Treatments Tested in This Trial?

Interventions

• PM14

Trial Overview The trial is testing PM14, an investigational drug for patients with advanced solid tumors. The study aims to find new treatment options that are not yet available and may work differently from existing therapies without having completely overlapping side effects.

How Is the Trial Designed?

Group I: PM14 Experimental Treatment 1 Intervention

Patients will receive PM14 as an i.v. infusion in a total volume of 100 mL of 0.9% sodium chloride at the first three dose escalation levels. Thereafter, the volume of infusion can be increased to 250 mL.

Who Is Running the Clinical Trial?

PharmaMar

Lead Sponsor

Trials

93

Recruited

11,800+

José María Fernández de Sousa-Faro

PharmaMar

Chief Executive Officer since 1986

PhD in Biochemistry, Complutense University of Madrid

Carmen Cuevas Marchante

PharmaMar

Chief Medical Officer since 2002

MD, University of Navarra

Published Research Related to This Trial

In a retrospective study of 123 patients receiving FOLFOX 4 chemotherapy for advanced colorectal cancer, significant adverse reactions were reported, including hemotoxicity (52.8%), chronic sensory neuropathy (16.2%), and allergic reactions (15.4%).

Common side effects during initial treatment included appetite loss (60.1%), vomiting (19.5%), and acute sensory neuropathy (33.3%), highlighting the need for improved patient education and pharmaceutical care to manage these reactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Drug information brochure for patients undergoing FOLFOX 4 chemotherapy based on survey of adverse reactions]. Imada, H., Kawakami, K., Hiraoka, T., et al.[2013]

In a study of 32 patients with non-small cell lung cancer treated with pembrolizumab, 31% experienced skin immune-related adverse effects (irAEs), indicating that these side effects are relatively common in this treatment group.

Patients who developed skin irAEs had a significantly longer progression-free survival (390 days) compared to those without skin irAEs (128.5 days), suggesting that the presence of these skin reactions may be a positive indicator of treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association between immune-related dermatologic adverse events and efficacy of pembrolizumab in non-small cell lung cancer patients. Fukuoka, T., Yamamoto, Y., Utsunomiya, J., et al.[2022]

The updated ASCO guidelines provide essential recommendations for managing immune-related adverse events in adult cancer patients undergoing treatment with immune checkpoint inhibitors, ensuring better patient safety and care.

These guidelines reflect the latest evidence and expert consensus, helping healthcare providers effectively address and mitigate potential side effects associated with immune checkpoint therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical guideline highlights for the hospitalist: Management of immune-related adverse events in patients treated with immune checkpoint inhibitor therapy. Chitnis, SD., Mortazavi, A.[2023]

A comprehensive review of 41 randomized controlled trials involving 23,121 patients found that treatments combining chemotherapy with immune checkpoint inhibitors (ICIs) significantly increased the risk of treatment-related adverse events compared to ICI-only regimens.

Among the various ICI treatments, the combination of PD-L1 and CTLA-4 with chemotherapy had the highest risk of immune-related adverse events, with severe cases like myocarditis and pneumonitis showing notably high fatality rates, indicating the need for careful monitoring and management in patients receiving these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system. Yan, YD., Zhao, Y., Zhang, C., et al.[2022]

The paper emphasizes the importance of developing robust serious adverse event (SAE) reporting procedures in non-pharmaceutical palliative care trials, as patients often face high risks of hospitalization or death due to their underlying conditions rather than the trial interventions.

Recommendations for improving SAE management include allowing sufficient planning time, defining what constitutes a serious adverse event for the specific study population, and refining reporting procedures throughout the trial to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What should we report? Lessons learnt from the development and implementation of serious adverse event reporting procedures in non-pharmacological trials in palliative care. Dunleavy, L., Collingridge Moore, D., Korfage, I., et al.[2021]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.3078

First-in-human study of PM14 in patients with advanced ... Two schedules were explored: Schedule A (Day 1 [D1], Day 8 [D8]) and Schedule B (D1). Results: 37 pts were treated (Schedule A/B: 28/9 pts).

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05146440

Study Details | NCT05146440 | Multicohort Trial of Different ... The aim of this study is to explore different infusions of PM14 (longer or repeated) in order to obtain a potentially better efficacy and similar toxicity ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05076396/pm14-administered-intravenously-to-patients-with-advanced-solid-tumors

PM14 Administered Intravenously to Patients with ... Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an ...

4. clinicaltrials.eu clinicaltrials.eu/trial/study-of-pm14-alone-and-with-radiotherapy-for-patients-with-advanced-soft-tissue-sarcomas-and-other-solid-tumors/

Study of PM14 Alone and with Radiotherapy for Patients ... This clinical trial investigates the efficacy of PM14, administered alone or in combination with radiotherapy, in treating advanced soft tissue sarcomas and ...

5. withpower.com withpower.com/trial/phase-1-neoplasms-8-2017-2209b

PM14 for Advanced Cancer This Phase 1 medical study run by PharmaMar is evaluating whether PM14 will have tolerable side effects & efficacy for patients with Solid Tumors and Cancer.

6. cancer.gov cancer.gov/clinicaltrials/NCI-2021-12417

PM14 Administered Intravenously to Patients with ... PM14 Administered Intravenously to Patients with Advanced Solid Tumors · Description · Eligibility Criteria · Locations & Contacts · Trial Objectives and Outline.

7. clinicaltrials.eu clinicaltrials.eu/trial/study-of-pm14-and-irinotecan-for-patients-with-advanced-solid-tumors/

Study of PM14 and Irinotecan for Patients with Advanced ... In this clinical trial, PM14 is being tested to find the best dose that patients can tolerate when used in combination with another cancer ...