RecruitingPhase 1Phase 2NCT05565807

Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma

A Phase Ib/IIa, Open-Label, Dose-Escalation and Extension Study to Evaluate the Safety and Efficacy of An Anti-CD38 Antibody Drug Conjugate (STI-6129) in Patients With Relapsed or Refractory Multiple Myeloma


Sponsor

Zhejiang ACEA Pharmaceutical Co. Ltd.

Enrollment

84 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase Ib/IIa, open-label, dose-escalation, and extension study to evaluate the safety and efficacy of an anti-CD38 antibody drug conjugate (STI-6129) in patients with relapsed or refractory multiple myeloma.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a new antibody-drug conjugate — a targeted treatment that delivers chemotherapy directly to myeloma cancer cells — for patients with multiple myeloma that has returned or stopped responding to treatment. This drug targets a protein called CD38, which is commonly found on myeloma cells. **You may be eligible if...** - You are 18 or older - You have relapsed or refractory multiple myeloma (cancer that returned or no longer responds to treatment) - You have already been treated with at least three different drug types (including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody) - Your disease has measurable signs in blood or urine tests - Your overall health status (ECOG score) is 0, 1, or 2 - You are using effective contraception if applicable **You may NOT be eligible if...** - You have active plasma cell leukemia, amyloidosis, or myeloma in the central nervous system - You have POEMS syndrome or spinal cord compression - You received certain prior therapies within the washout period - You are known to be allergic to this drug's ingredients 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

BIOLOGICALSTI-6129

Anti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor.


Locations(4)

Beijing Chao-Yang Hospital,Capital Medicine University

Beijing, Beijing Municipality, China

Peking university Third hospital

Beijing, Beijing Municipality, China

The first affiliated hospital ,Sun Yat-sen University

Guangzhou, Guangdong, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

View Full Details on ClinicalTrials.gov

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

Visit

NCT05565807


Related Trials