PM14 for Advanced Cancer

Recruiting in Palo Alto (17 mi)

+8 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: PharmaMar

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Uncontrolled hypertension, Active infection, HIV, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called PM14 for patients with advanced cancers that are hard to treat. The goal is to find the safest and most effective dose by adjusting the amount given to avoid severe side effects.

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 PM14 generally safe for humans?

The treatment, also known as pembrolizumab, has been associated with skin-related side effects in some patients with lung cancer, but these effects might indicate the treatment is working. It's important for medical staff to monitor these side effects closely. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• PM14 (Other)

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.

Participant Groups

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.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Massachusetts General Hospital Boston, MA

Who Is Running the Clinical Trial?

PharmaMar

Lead Sponsor

Trials

93

Patients Recruited

11,800+

Findings from Research

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]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Association between immune-related dermatologic adverse events and efficacy of pembrolizumab in non-small cell lung cancer patients. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Toxicity spectrum of immunotherapy in advanced lung cancer: A safety analysis from clinical trials and a pharmacovigilance system. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

[Drug information brochure for patients undergoing FOLFOX 4 chemotherapy based on survey of adverse reactions]. [2013]

4. United States 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. [2023]

5. England 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. [2021]