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PM14 Administered Intravenously to Patients With Advanced Solid Tumors

NCT05076396 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 126

Last updated 2026-05-11

No results posted yet for this study

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.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

PM14

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.

Sponsors & Collaborators

  • PharmaMar

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-06
Primary Completion
2025-08-21
Completion
2025-08-21
FDA Drug
Yes

Countries

  • United States
  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05076396 on ClinicalTrials.gov