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.
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. The study is designed to identify the recommended phase 2 dose (RP2D) of STI-6129 by assessing the safety, preliminary efficacy and pharmacokinetics using a accelerated titration design and a conventional 3+3 study design for dose escalation in stage one and then the second stage will be an expansion study to assess preliminary efficacy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Anti-CD38 A2 human antibody drug conjugate (ADC) containing an antibody covalently bound to a duostatin tubulin inhibitor.
Beijing Chao-Yang Hospital,Capital Medicine University
Beijing, Beijing Municipality, China
RECRUITINGPeking university Third hospital
Beijing, Beijing Municipality, China
RECRUITINGThe first affiliated hospital ,Sun Yat-sen University
Guangzhou, Guangdong, China
Incidence of adverse events(AEs)
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Time frame: Up to 2 years
Overall response rate(ORR)
ORR assessed by the modified IMWG response criteria.
Time frame: Up to 2 years
Plasma concentration of the total anti-CD38 antibody
Determine plasma levels of the total antibody.
Time frame: Up to 2 years
Plasma concentration of conjugated toxin
Determine plasma levels of conjugated toxin (STI 6129).
Time frame: Up to 2 years
Plasma concentration of the free toxin
Determine plasma levels of the free toxin (duostatin 5.2).
Time frame: Up to 2 years
Recommended Phase 2 dose (RP2D)
Determined according to the phase 1b.
Time frame: Up to 2 years
Progression-Free Survival
PFS is the period from patient enrollment until PD or death.
Time frame: Up to 2 years
Overall Survival (OS)
OS is the period from enrollment until death from any cause.
Time frame: Up to 2 years
Time To First Response(TTR)
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The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
RECRUITINGTTR is the period from the date of patient registration to the date of first response.
Time frame: Up to 2 years
Duration of Response (DOR)
DOR is the period from the first documentation of response (CR or PR) to the first documentation of PD.
Time frame: Up to 2 years
Clinical Benefit Rate (CBR)
CBR is the percentage of participants achieving a CR or PR at any time during the study or maintaining stable disease for at least 4 weeks from the first dose of study intervention.
Time frame: Up to 2 years