RecruitingPhase 1NCT05989724

A First-in-Human Study of SON-DP in Participants With Relapsed/Refractory Intolerant to Standard of Care Therapies for Advanced/Metastatic Solid Tumors

A First-in-Human (FIH), Open-Label, Phase Ia/Ib Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SON-DP in Participants With Relapsed/Metastatic Solid Tumors


Sponsor

Qurgen Inc.

Enrollment

150 participants

Start Date

Sep 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This proposed Phase I clinical trial of SON-DP is an FIH, open-label, Phase Ia/Ib dose escalation and expansion study to evaluate the safety, tolerability, PK, and PD of SON-DP in participants with relapsed/refractory/intolerant to standard of care therapies, for advanced/ metastatic solid tumors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a first-in-human study testing a new experimental drug called SON-DP in people with advanced solid tumors — including breast, pancreatic, ovarian, and colorectal cancers — whose cancer has not responded to standard treatments. **You may be eligible if...** - You are 18 years or older - You have a confirmed solid tumor that has not responded to or relapsed after standard treatments - You have good physical function (ECOG 0-1) - In the second phase: your cancer is breast, pancreatic, ovarian, or colorectal **You may NOT be eligible if...** - Your cancer is not a solid tumor or not one of the specified types in the expansion phase - Your general health is too poor to tolerate investigational therapy - You have not exhausted standard treatment options Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGSON-DP

Solution for IV administration


Locations(5)

Banner MD Anderson Cancer Center (BMDACC)

Gilbert, Arizona, United States

Henry Ford Health System

Detroit, Michigan, United States

Carolina BioOncology Institute

Huntersville, North Carolina, United States

Stephenson Cancer Center, University of Oklahoma

Oklahoma City, Oklahoma, United States

MD Anderson Cancer Center

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05989724


Related Trials