NCT05565807RecruitingPhase 1
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 enrollmentStarted: February 9, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 84
- Locations
- 4
- Primary Endpoint
- Overall response rate（ORR）
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
- •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
- •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.
Arms & Interventions
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.
Intervention: STI-6129 (Biological)
Outcomes
Primary Outcomes
Overall response rate（ORR）
Time Frame: Up to 2 years
ORR assessed by the modified IMWG response criteria.
Incidence of adverse events（AEs）
Time Frame: Up to 2 years
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Secondary Outcomes
- Clinical Benefit Rate (CBR)(Up to 2 years)
- Plasma concentration of the total anti-CD38 antibody(Up to 2 years)
- Time To First Response（TTR）(Up to 2 years)
- Overall Survival (OS)(Up to 2 years)
- Plasma concentration of conjugated toxin(Up to 2 years)
- Recommended Phase 2 dose (RP2D)(Up to 2 years)
- Progression-Free Survival(Up to 2 years)
- Plasma concentration of the free toxin(Up to 2 years)
- Duration of Response (DOR)(Up to 2 years)
Investigators
Study Sites (4)
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