RecruitingPhase 1NCT07424547

Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors

Phase I Dose Escalation and Cohort Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6043 in Patients With Advanced/Metastatic Solid Tumors


Sponsor

Conjupro Biotherapeutics, Inc.

Enrollment

386 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works. Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment. * Have safety follow-up (SFU), and long-term follow-up. * Be followed until progression.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 clinical trial testing the safety and dosing of a new cancer drug called SYS6043 in people with advanced or metastatic solid tumors that have stopped responding to standard treatments. The main goal is to find a safe dose before larger trials are conducted. **You may be eligible if...** - You are 18 years old or older - You have an advanced or metastatic solid tumor confirmed by biopsy or cytology that has progressed on or after standard treatments - You have at least one measurable area of cancer - You have a life expectancy of at least 3 months - You are in relatively good health (ECOG performance status 0–1) **You may NOT be eligible if...** - You are not well enough to tolerate treatment - Your cancer has not been confirmed by a pathology test - You have no measurable areas of cancer 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

DRUGSYS6043

Administered by intravenous injection


Locations(5)

BRCR Global

Plantation, Florida, United States

Florida Clinical Trials Group

Plantation, Florida, United States

NEXT Oncology Austin

Austin, Texas, United States

NEXT Oncology San Antonio

San Antonio, Texas, United States

NEXT Oncology Virginia

Fairfax, Virginia, United States

View Full Details on ClinicalTrials.gov

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

Visit

NCT07424547


Related Trials