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

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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 2.

• 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.

Locations
Other Locations
China
Beijing Chao-Yang Hospital,Capital Medicine University
RECRUITING
Beijing
Peking university Third hospital
RECRUITING
Beijing
The first affiliated hospital ,Sun Yat-sen University
RECRUITING
Guangzhou
The First Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Hangzhou
Contact Information
Primary
chao wang, master
chao.wang@aceapharma.com
15838131673
Backup
meiping kong, bachelor
meiping.kong@aceapharma.com
13735478976
Time Frame
Start Date: 2023-02-09
Estimated Completion Date: 2028-02-19
Participants
Target number of participants: 84
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: Zhejiang ACEA Pharmaceutical Co. Ltd.

This content was sourced from clinicaltrials.gov