EUCTR2020-003414-12-DE进行中（未招募）1 期
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients are eligible to be included in the study only if all following criteria apply:
- •1.Patients who have signed an informed consent and are willing to comply with the requirements and restrictions listed in the study protocol.
- •2.Male or female aged =18 years at the time of informed consent.
- •3.Life expectancy >12 weeks, as determined by the Investigator.
- •4.Eastern Cooperative Oncology Group Performance Status (PS) of 0 to 2 (tumor related performance).
- •5.A confirmed diagnosis of active MM according to the diagnostic criteria established by the International Myeloma Working Group (IMWG).
- •6.Must have undergone SCT or is considered transplant ineligible.
- •7.Must have undergone prior treatments with antimyeloma therapy which must have included an immunomodulatory drug, proteasome inhibitor, and antiCD38 treatment, alone or in combination. Patients who are intolerant to these therapies or have contraindications are eligible if other eligibility criteria are fulfilled. Patient must have failed last line of treatment (refractory to or relapsed after last line of treatment) or had to permanently discontinue the last line of therapy due to toxicity (toxicity and reason for permanent discontinuation has to be documented in the electronic case report form [eCRF]). In addition, the patient should either refractory or intolerant to any established standard of care therapy providing a meaningful clinical benefit for the patient assessed by the Investigator.
- •8.a)Phase 1 part only: patients with non-secretory or oligo-secretory myeloma (NSMM) not meeting the measurability criteria described in
- •8.b)are eligible (all other eligibility criteria must apply).
- •Phase 2a part only - Measurable disease defined as:
- •Serum M-protein =0.5 g/dL, or
- •Urine M-protein =200 mg/24 hours, or
- •Serum-free light chains (FLC) assay: involved FLC level =10 mg/dL (100 mg/L) provided serum FLC ratio is abnormal (<0.26 or >1.65).
- •9. Acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to Grade 0 or 1 as per the NCI-CTCAE, except for alopecia and Grade 2 neuropathy.
- •10.Adequate organ system function asdefined:
- •Absolute neutrophil count: =1.0 × 10^9/L
- •Platelet count: =75 × 10^9/L and absent platelet transfusion for =7 days
- •Hemoglobin: >8.0 g/dL and absent RBC transfusion for =7 days
- •Activated partial thromboplastin time/partial thromboplastin time: =1.5 × ULN
- •Measured creatinine clearance (using 24-hour urine), if a measured Cr-Cl is not available, the calculated creatinine clearance using the Cockcroft-Gault-Formula can be used =60 mL/min
- •Albuminuria: =500 mg/24hours
- •Total serum bilirubin: =1.5 × ULN (isolated bilirubin >1.5 and =3.0 × ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •Aspartate and alanine transaminases: =1.5 × ULN
- •11.A female patient is eligible to participate if she is of
- •Nonchildbearing potential defined as premenopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle-stimulating hormone [FSH] >40 MIU/mL and estradiol <40 pg/mL [<147 pmol/L] is confirmatory). Women on hormone replacement therapy (HRT) and whose menopausal status is in doubt are treated like women of childbearing potential unless they discontinue their HRT to allow confirmation of postmenopausal status prior to study enrollment. For most forms of HRT, at least 2 to 4 weeks will elapse betw
排除标准
- •Patients are excluded from the study if any of the following criteria apply:
- •1. For patient entering the Phase 2a part only: Prior treatment with any approved or experimental BCMA-targeting modalities are not allowed including but not limited to chimeric antigen receptor T or NK cell treatment, mono or bispecific antibodies and other BCMA-ADCs. (Note that patients in the Phase 1 part could have had any prior BCMA directed treatment providing they fulfilled all other I/E criteria).
- •2. History of allergic reactions to any component of the study treatment.
- •3. Known central nervous system involvement.
- •4. Plasma cell leukemia (total plasma cell count of at least 2 × 10^9/L) at Screening.
- •5. History of congestive heart failure classified as Class = III based on the NYHA Classification or Grade 3/4 unstable angina pectoris within 6 months of enrollment, presence of unstable atrial fibrillation, ECG with QTc =480 ms, cardiac arrhythmia, or uncontrolled hypertension.
- •6. Treatment with systemic anticancer therapy within 4 weeks or 5 t½s of the agent if t½ is known (whichever is shorter) before first dose of the study treatment. Anticancer therapies include cytotoxic chemotherapy, targeted inhibitors, and immunotherapies, but do not include radiotherapy or corticosteroids.
- •7. Higher dose of systemic corticosteroids, defined as oraldexamethasone >40 mg/day (for patients aged >75 years reduced to >20 mg/day) or equivalent, within 3 days prior to the first study treatment infusion.
- •8. Currently participating in a study and receiving study therapy or participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of study treatment.
- •9. Autologous or allogenic SCT within 12 weeks before the first infusion or is planning for autologous SCT.
- •10. Symptomatic graft versus host disease post allogenic hemopoietic cell transplant within 12 months prior to the first study treatment infusion.
- •11. Significant surgical intervention within 21 days prior to the first study treatment infusion or ongoing post-operative complications.
- •12.Patients who have a history of being nonresponsive to platelet and/or RBC transfusions and expected lack of adequate support with blood products on demand.
- •13. Radiotherapy within 21 days prior to the first study treatment infusion, or localized palliative radiotherapy within 7 days prior to the first study treatment infusion, therapy with radio immuno-conjugates performed less than 3 months prior to the first dose of study treatment.
- •14. Herbal remedies interfering or stimulating the metabolic pathways (eg, mistletoe extract) or known to potentially interfere with major organ function (eg, hypericin) within 21 days prior to the first study treatment infusion.
- •15. History of any other malignancy known to be active, with the exception of completely removed in situ cervical intraepithelial neoplasia, nonmelanoma skin cancer, ductal carcinoma in situ, early stage prostate cancer that has been adequately treated. Malignancies which are adequately treated and requiring hormonal therapies only to prevent the recurrence of the malignancy other than multiple myeloma may be permitted after discussion with and agreement of the Sponsor's Medical Monitor (eg, breast cancer treated with hormonal therapies).
- •16. For sites in Germany: HIV infection at the time of the screening. For all other sites: Known human immunodeficiency virus infection.
研究者
相似试验
招募中
2 期
A Phase 1/2a, First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HDP-101 in Patients with Plasma Cell Disorders Including Multiple Myeloma2024-515273-10-00Heidelberg Pharma AG71
进行中（未招募）
1 期
A first-in-human study of UX053 in Patients with Glycogen Storage Disease type III (GSD III)Glycogen Storage Disease Type III (GSD III)MedDRA version: 20.1Level: PTClassification code 10053250Term: Glycogen storage disease type IIISystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-000903-19-ITTRAGENYX PHARMACEUTICAL INC.30
进行中（未招募）
1 期
A first-in-human study of UX053 in Patients with Glycogen Storage Disease type III (GSD III)Glycogen Storage Disease Type III (GSD III)MedDRA version: 20.1Level: PTClassification code 10053250Term: Glycogen storage disease type IIISystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2021-000903-19-ESltragenyx Pharmaceutical Inc.30
招募中
1 期
[M23-385]A Phase 1 study of ABBV-706 alone or in combination in adult subjects with advanced solid tumors.Advanced solid tumors with potential SEZ6 expressionJPRN-jRCT2031230510Yamagishi Chika350
招募中
1 期
A Phase I/II First-In-Human Clinical Trial to Evaluate the Safety, Tolerability and Anti-Tumor Activity of IMA402, a Bispecific T Cell-Engaging Receptor Molecule (TCER®) targeting PRAME, in Patients with Recurrent and/or Refractory Solid TumorsSolid TumorsMedDRA version: 21.1Level: LLTClassification code: 10065252Term: Solid tumor Class: 10029104CTIS2022-503133-54-00Immatics Biotechnologies GmbH155