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

NCT05565807 | Recruiting Phase 1

• 1 other identifier: 38ADC-RRMM-C101
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse events（AEs）

  Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).

  Up to 2 years

• Overall response rate（ORR）

  ORR assessed by the modified IMWG response criteria.

  Up to 2 years

Secondary Outcomes (9)

• Plasma concentration of the total anti-CD38 antibody

  Up to 2 years

• Plasma concentration of conjugated toxin

  Up to 2 years

• Plasma concentration of the free toxin

  Up to 2 years

• Recommended Phase 2 dose (RP2D)

  Up to 2 years

• Progression-Free Survival

  Up to 2 years

Study Arms (1)

STI-6129

EXPERIMENTAL

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.

Biological: STI-6129

Interventions

STI-6129 BIOLOGICAL

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

STI-6129

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 CYP3A4.
• 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.
• Had received autologous hematopoietic stem cell transplantation within 12 weeks before the first administration of the study drug.
• Had undergone major surgery or eye surgery within 28 days before the first administration of the study drug.
• Other malignant diseases within 3 years before the first administration of the study drug.
• History of grade ≥3 (muscle paralysis, eyelid disease, glaucoma requiring drug control, tearing eyes), or grade ≥2 any other ocular disease (as judged by NCI-CTCAE version 5.0) at screening.
• Has ≥ Grade 3 neuropathy or Grade 2 neuropathy with associated pain.

Sponsors & Collaborators

• Zhejiang ACEA Pharmaceutical Co. Ltd.: lead

Study Sites (4)

Beijing Chao-Yang Hospital，Capital Medicine University

Beijing, Beijing Municipality, 100000, China

RECRUITING

Peking university Third hospital

Beijing, Beijing Municipality, 100191, China

RECRUITING

The first affiliated hospital ,Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• jie jin, doctor

  Zhejiang University

  PRINCIPAL INVESTIGATOR

• juan li, doctor

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

chao wang, master

CONTACT

15838131673; chao.wang@aceapharma.com

meiping kong, bachelor

CONTACT

13735478976; meiping.kong@aceapharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: To determine DLT and RP2D, the design uses a accelerated titration design and a 3+3 design for the dose-escalation stage.

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 4, 2022
• Study Start: February 9, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): February 19, 2028
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

CN (4)