OncoMatch/Clinical Trials/NCT05565807
Safety and Efficacy Study of An Anti-CD38 Antibody Drug Conjugate in Relapsed or Refractory Multiple Myeloma
Is NCT05565807 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies STI-6129 for relapsed or refractory multiple myeloma.
Treatment: STI-6129 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Multiple Myeloma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: proteasome inhibitor
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
Must have received: immunomodulatory drug
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
Must have received: anti-CD38 antibody
Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
Cannot have received: plasma exchange therapy
Had received plasma exchange therapy within 28 days before the first administration of the study drug.
Cannot have received: monoclonal antibody
Had received...monoclonal antibody...within 28 days
Cannot have received: cytotoxic drug
Had received...cytotoxic drug...within 28 days
Cannot have received: radiation therapy
Had received...radiotherapy within 28 days
Cannot have received: immunoregulator
Had received...immunoregulator...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: targeted therapy
Had received...targeted therapy...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: epigenetic therapy
Had received...epigenetic therapy...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: investigational medical product
Had received...investigational medical product...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: invasive investigational medical device
Had received...invasive investigational medical device...within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: other anti-myeloma therapy
Had received...other anti-myeloma therapy within 28 days or 5 half-lives (whichever is shorter)
Cannot have received: proteasome inhibitor
Had received...proteasome inhibitor...within 14 days
Cannot have received: anti-tumor traditional Chinese medicine treatment
Had received...anti-tumor traditional Chinese medicine treatment...within 14 days
Cannot have received: corticosteroids
Exception: cumulative dose of more than 140 mg prednisone (or equivalent) or a single dose of more than 40 mg/day dexamethasone (or equivalent) within 14 days
Had received...corticosteroids with a cumulative dose of more than 140 mg prednisone (or equivalent) or a single dose of more than 40 mg/day dexamethasone (or equivalent) within 14 days
Cannot have received: CAR-T cell therapy
Had received CAR-T therapy...within 6 months before the first administration of the study drug
Cannot have received: allogeneic hematopoietic stem cell transplantation
Had received...allogeneic hematopoietic stem cell transplantation therapy within 6 months before the first administration of the study drug
Cannot have received: autologous hematopoietic stem cell transplantation
Had received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration of the study drug
Lab requirements
Blood counts
Hemoglobin <80g/L, Platelet count <50×10^9/L, Absolute neutrophil count <1.0×10^9/L excluded
Kidney function
Estimated creatinine clearance <30mL/min excluded
Liver function
AST or ALT >3×upper limit of normal (ULN) or serum total bilirubin > 1.5×ULN excluded
Cardiac function
NYHA class >2, unstable angina, MI within 6 months, poorly controlled arrhythmias, QTcF >470msec, LVEF <40%, poorly controlled hypertension, stroke/cerebrovascular accident/TIA within 6 months excluded
Has the following hematological test results within 7 days before the first administration of the study drug: 1. Hemoglobin <80g/L 2. Platelet count <50×10^9/L 3. Absolute neutrophil count <1.0×10^9/L. Has the following blood chemistry test results within 7 days before the first administration of the study drug: 1. Estimated creatinine clearance <30mL/min. 2. AST or ALT>3×upper limit of normal (ULN) or serum total bilirubin> 1.5×ULN. Severe or uncontrolled cardiovascular and cerebrovascular diseases requiring treatment, including: 1. New York Heart Association class>2; 2. Unstable angina pectoris that cannot be controlled by drugs; 3. Myocardial infarction occurred within 6 months before the first administration of the study drug; 4. Poorly controlled arrhythmias; 5. 12-lead ECG QTcF>470msec; 6. Left ventricular ejection fraction <40%; 7. Poorly controlled hypertension ; 8. Stroke, cerebrovascular accident, or transient ischemic attack occurred within 6 months before the first administration of the study drug.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify