RecruitingPhase 1NCT05076396

PM14 Administered Intravenously to Patients with Advanced Solid Tumors

Phase I, Open-label, Dose-escalating, Clinical and Pharmacokinetic Study of PM14 Administered Intravenously to Patients with Advanced Solid Tumors

Sponsor

PharmaMar

Enrollment

150 participants

Start Date

Sep 6, 2017

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor

Summary

Despite recent advances in the treatment of solid tumors in general, advanced (metastatic) disease remains mostly incurable and there is an urgent need to develop new therapeutic options for these patients, particularly investigational drugs with novel mechanisms of action. The investigation of new combination regimens of non-crossresistant agents with acceptable-and not completely overlapping-toxicities has been a major way to improve response rate and outcome of patients with advanced solid tumors.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 study is testing a new investigational drug called PM14 — given by IV infusion — in patients with advanced solid tumors to find the safest dose and see early signs of anti-cancer activity. PM14 works through a novel mechanism and is being explored in cancers such as colorectal cancer, sarcomas, ovarian cancer, breast cancer, and adrenocortical carcinoma, among others. Adults 18 and older with a confirmed advanced cancer diagnosis, good performance status, and adequate organ function are eligible if standard treatments have failed or are unavailable — those with serious heart conditions, active infections, or prior bone marrow transplants are excluded. Participation involves regular IV infusion visits in escalating dose rounds, with blood tests, ECGs, and imaging to monitor safety and tumor response. This summary was prepared with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPM14

PM14 drug product is provided as a sterile lyophilized powder for concentrate for solution for infusion with a strength of 5.0 mg of the active moiety. 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.