What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as paclitaxel, carboplatin, and gemcitabine, are associated with a range of side effects. Paclitaxel can cause neuropathy, neutropenia, and fatigue. Carboplatin is linked to hematologic toxicities like anemia, neutropenia, and thrombocytopenia. Gemcitabine may result in nausea, diarrhea, and neutropenia. Combination therapies, such as gemcitabine with nab-paclitaxel, can lead to higher rates of neutropenia, febrile neutropenia, fatigue, and neuropathy. These side effects are crucial considerations in treatment planning.

What prior FDA approvals exist?

The FDA has approved several antitumor agents and immunotherapies for the treatment of solid tumors. Notable examples include pembrolizumab and nivolumab, which are immune checkpoint inhibitors targeting PD-1, and have shown efficacy in various solid tumors such as melanoma and non-small cell lung cancer. Additionally, combination therapies like nivolumab with ipilimumab (an anti-CTLA-4 antibody) have been approved for melanoma. These treatments are similar to the investigational agent PM54, which is being studied for its antitumor activity in advanced solid tumors.

What other types of research exist?

Promising novel alternatives to PM54 for solid tumor patients include: 1) M3814 in combination with PLD, which has shown enhanced activity in ovarian cancer models. 2) STK899704, a tubulin inhibitor with efficacy comparable to 5-fluorouracil. 3) SKI 2054R, a new platinum compound with antitumor activity comparable to CDDP.

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PM54 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by PharmaMar

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up start of treatment to date of progression or start of subsequent therapy or end of patient's follow-up, per recist v.1.1(or mrecist v.1.1 in case of malignant pleural mesothelioma [mpm]) and/or serum markers.(up to approximately 36 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called PM54 to see if it is safe and effective in shrinking tumors and keeping them stable for several months in patients with advanced cancer.

Who is the study for?

This trial is for adults over 18 with advanced solid tumors, including specific cancers of the urinary tract, skin (melanoma), gastrointestinal system, lung, gynecological organs, breast and certain sarcomas. Participants must be in fairly good health otherwise (ECOG ≤1).

What is being tested?

PM54's safety and maximum tolerated dose are being tested first. Then its effectiveness against tumor growth will be assessed using imaging criteria (RECIST v.1.1) or serum markers in patients with selected advanced solid tumors.

What are the potential side effects?

Possible side effects include reactions related to the dosage of PM54 which may affect different body systems but specifics will become clearer as the trial progresses through its phases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ start of treatment to date of progression or start of subsequent therapy or end of patient's follow-up, per recist v.1.1(or mrecist v.1.1 in case of malignant pleural mesothelioma [mpm]) and/or serum markers.(up to approximately 36 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~start of treatment to date of progression or start of subsequent therapy or end of patient's follow-up, per recist v.1.1(or mrecist v.1.1 in case of malignant pleural mesothelioma [mpm]) and/or serum markers.(up to approximately 36 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and start of treatment to date of progression or start of subsequent therapy or end of patient's follow-up, per recist v.1.1(or mrecist v.1.1 in case of malignant pleural mesothelioma [mpm]) and/or serum markers.(up to approximately 36 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1a: Maximum tolerated dose (MTD)

Phase 1a: Recommended dose (RD)

Phase 1b: Percentage of evaluable patients with clinical benefit

Secondary study objectives

Phase 1b: Adverse events (AEs)

Phase 1b: QT Assessment

Phase 1b: Response rate

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PM54Experimental Treatment1 Intervention

Phase Ia (dose escalation) stage: Patients will receive PM54 i.v. at a starting dose of 0.3 mg/m2. Phase Ib (expansion) stage: Patients will receive PM54 i.v. at the RD determined during the Phase Ia stage.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cells, which includes cancer cells, but also affects normal cells, leading to side effects. Targeted therapies, such as tyrosine kinase inhibitors, specifically target molecular abnormalities in cancer cells, thereby minimizing damage to normal cells. Immunotherapy, including checkpoint inhibitors like anti-PD-1 and anti-CTLA-4, enhances the body's immune response against cancer cells. These treatments are crucial for solid tumor patients as they offer different mechanisms to control or shrink tumors, potentially leading to better outcomes and personalized treatment plans.

Current trends and future directions in the genetic therapy of human neoplastic disease.