NCT05565807招募中1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 4
- 主要终点
- Overall response rate（ORR）
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: STI-6129 (Biological)
结局指标
主要结局
Overall response rate（ORR）
时间窗: Up to 2 years
ORR assessed by the modified IMWG response criteria.
Incidence of adverse events（AEs）
时间窗: Up to 2 years
Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
次要结局
- 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)
研究者
研究点 (4)
Loading locations...
相似试验
招募中
1 期
H002 in Patients With EGFR Mutation Locally Advanced or Metastatic NSCLCNon-small Cell Lung CancerNCT05552781RedCloud Bio76
招募中
1 期
Phase I/IIa Study of H002 in NSCLC With Active EGFR MutationNon-small Cell Lung CancerNCT05519293RedCloud Bio76
招募中
1 期
A Study to Assess the Safety, Pharmacokinetics, and Antitumor Activity of BC3195 in Patients With Advanced or Metastatic CancerAdvanced CancerMetastatic Solid TumorNCT06548672Biocity Biopharmaceutics Co., Ltd.148
进行中（未招募）
1 期
A Study of LM-108 as Monotherapy or in Combination With Antitumor Therapies in Subjects With Advanced Solid TumorsAdvanced Solid TumorNCT05518045LaNova Medicines Limited392
尚未招募
1 期
Study of NM8074 in Adult C3 Glomerulopathy PatientsC3 GlomerulopathyNCT05647811NovelMed Therapeutics18