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

Zhejiang ACEA Pharmaceutical Co. Ltd.4 sites in 1 country84 target enrollmentFebruary 9, 2023

ConditionsRelapsed or Refractory Multiple Myeloma

InterventionsSTI-6129

DrugsSTI-6129

Overview

Phase: Phase 1
Intervention: STI-6129
Conditions: Relapsed or Refractory Multiple Myeloma
Sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.
Enrollment: 84
Locations: 4
Primary Endpoint: Overall response rate（ORR）
Status: Recruiting
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 9, 2023

End Date

February 19, 2028

Last Updated

8 months ago

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Zhejiang ACEA Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age ≥18 years old, regardless of gender.
•Previously treated with at least three drugs (including PI, IMiD, and anti-CD38 antibody), and relapsed/refractory after the most recent anti-MM therapy.
•Diagnosis of MM according to IMWG criteria with measurable lesions, meeting at least 1 of the following criteria:
•Serum M protein ≥ 0.5g/dL (≥ 5 g/L); or
•Urine M protein ≥ 200mg/24 hours; or
•When the serum free light chain (FLC) ratio is abnormal, the affected FLC level is ≥10mg/dL (≥100 mg/L) (the normal FLC ratio is 0.26 to 1.65).
•ECOG performance status score is 0, 1, or
•Willing and able to comply with the study schedule and all other study protocol requirements.
•Women of childbearing potential (WOCBP) (infertile women are defined as sexually mature females who had undergone a hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition or spontaneously menopausal for ≥ 12 months) must have a negative blood pregnancy test during the screening. Female subjects of childbearing potential and male subjects with fertility must use a highly effective method of contraception from screening to 6 months after the last treatment.

Exclusion Criteria

•Known hypersensitivity to any of the ingredients of this product.
•Diagnosis of active plasma cell leukemia.
•Diagnosis of systemic light chain amyloidosis.
•MM involving the central nervous system.
•Has POEMS syndrome.
•There is spinal cord compression associated with MM.
•Needs to take concomitant drugs with a strong inhibitory effect or a strong induction effect on CYP3A
•Had received plasma exchange therapy within 28 days before the first administration of the study drug.
•Had received the following anti-tumor treatments before the first administration of the study drug: monoclonal antibody or cytotoxic drug or radiotherapy within 28 days; immunoregulator, targeted therapy or epigenetic therapy or investigational medical product or invasive investigational medical device or other anti-myeloma therapy within 28 days or 5 half-lives (whichever is shorter); proteasome inhibitor or anti-tumor traditional Chinese medicine treatment or 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.
•Had received CAR-T therapy or allogeneic hematopoietic stem cell transplantation therapy within 6 months before the first administration of the study drug, or have a concomitant disease of active graft-versus-host disease (GvHD) at screening.

Arms & Interventions

STI-6129

Nine dosing cohorts will be evaluated: 0.25 mg/kg，0.50 mg/kg，0.67 mg/kg, 0.88 mg/kg, 1.18 mg/kg, 1.56 mg/kg, 2.08 mg/kg, 2.77 mg/kg, 3.68 mg/kg where STI-6129 will be intravenously administered once as part of a 4-week treatment cycle.

Intervention: STI-6129