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Relapsed or Refractory Multiple MyelomaPhase 1/2NCT05565807

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

A Phase 1/2 study testing STI-6129 in people with Relapsed or Refractory Multiple Myeloma, run by Zhejiang ACEA Pharmaceutical Co. Ltd. at 4 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Relapsed or Refractory Multiple Myeloma
What is being tested?
STI-6129
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
4 sitesChina
Study dates
9 Feb 2023to 19 Feb 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).
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  • 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.

Who cannot join

  • 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.
Show all 40Show fewer
  • 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.
  • The toxicity caused by the previous anti-tumor treatment did not subside to ≤ grade 1.
  • Has the following hematological test results within 7 days before the first administration of the study drug:
  • Hemoglobin <80g/L
  • Platelet count <50×10^9/L
  • 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:
  • Estimated creatinine clearance <30mL/min.
  • 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:
  • New York Heart Association class>2;
  • Unstable angina pectoris that cannot be controlled by drugs;
  • Myocardial infarction occurred within 6 months before the first administration of the study drug;
  • Poorly controlled arrhythmias;
  • 12-lead ECG QTcF>470msec;
  • Left ventricular ejection fraction <40%;
  • Poorly controlled hypertension ;
  • Stroke, cerebrovascular accident, or transient ischemic attack occurred within 6 months before the first administration of the study drug.
  • Meets any of the following criteria:
  • Known chronic obstructive pulmonary disease (COPD) and forced expiratory volume in 1 second (FEV1) <50% of predicted normal;
  • Known moderate or severe persistent asthma, or a history of asthma within the past 2 years, or current uncontrolled asthma of any classification;
  • with interstitial lung disease requiring corticosteroid therapy, drug-induced interstitial lung disease, a history of radiation pneumonitis, orclinically active interstitial lung disease suggested by any current evidence before the first administration of the study drug.
  • Has an active bacterial, viral, or fungal infection or needs for intravenous antibiotic administration (IV) within 72 hours before the first administration of the study drug.
  • Active or uncontrolled HBV , HCV , HIV positive.
  • Is currently pregnant or breast feeding.
  • Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

chao wang, master contact

15838131673

chao.wang@aceapharma.com

meiping kong, bachelor contact

13735478976

meiping.kong@aceapharma.com

China4 sites, 4 recruiting

  • Beijing Chao-Yang Hospital，Capital Medicine University

    Beijing, Beijing Municipality, 100000

    wenming chen, doctor, 010-85231000, 13910107759@163.com

    Recruiting

  • Peking university Third hospital

    Beijing, Beijing Municipality, 100191

    hongmei jing, doctor, 010-82265531, bysyjhm@sina.com

    Recruiting

  • The first affiliated hospital ,Sun Yat-sen University

    Guangzhou, Guangdong, 510080

    juan LI, doctor, 13719209240, 13719209240@163.com

    Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Jie Jin, 0571-87236898, jiej0503@163.com

    Jie Jin

    Recruiting

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
STI-6129
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • STI-6129Biological

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

Study groups in NCT05565807
Study groupRoleWhat they receive
STI-6129ExperimentalNine 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.
Receives: Biological: STI-6129

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events（AEs）

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

    Measured: Up to 2 years

  2. Overall response rate（ORR）

    ORR assessed by the modified IMWG response criteria.

    Measured: Up to 2 years

Secondary outcomes (9)

  1. Plasma concentration of the total anti-CD38 antibody

    Determine plasma levels of the total antibody.

    Measured: Up to 2 years

  2. Plasma concentration of conjugated toxin

    Determine plasma levels of conjugated toxin (STI 6129).

    Measured: Up to 2 years

  3. Plasma concentration of the free toxin

    Determine plasma levels of the free toxin (duostatin 5.2).

    Measured: Up to 2 years

  4. Recommended Phase 2 dose (RP2D)

    Determined according to the phase 1b.

    Measured: Up to 2 years

  5. Progression-Free Survival

    PFS is the period from patient enrollment until PD or death.

    Measured: Up to 2 years

  6. Overall Survival (OS)

    OS is the period from enrollment until death from any cause.

    Measured: Up to 2 years

  7. Time To First Response（TTR）

    TTR is the period from the date of patient registration to the date of first response.

    Measured: Up to 2 years

  8. Duration of Response (DOR)

    DOR is the period from the first documentation of response (CR or PR) to the first documentation of PD.

    Measured: Up to 2 years

  9. 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.

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2022
  2. Study start9 Feb 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion19 Feb 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
To determine DLT and RP2D, the design uses a accelerated titration design and a 3+3 design for the dose-escalation stage.
Masking
None (open label)
Enrolment
84 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05565807
Sponsor's protocol ID
38ADC-RRMM-C101
Status last verified
Aug 2025
First submitted
27 Sep 2022
Last updated
15 Aug 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing STI-6129 in people with Relapsed or Refractory Multiple Myeloma, run by Zhejiang ACEA Pharmaceutical Co. Ltd. at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact chao wang, master (15838131673, chao.wang@aceapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events（AEs） (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05565807.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2025.

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