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项与 DM-002 (Xadcera Biopharma) 相关的临床试验A Phase I, Multicentre, Open-label, First-in-Human, Dose Escalation and Expansion Study of DM002 in Patients With Advanced Solid Tumors
The goal of study:
The study has two parts: Part 1 Dose Escalation and Part 2 Dose Expansion.
In Part 1, a few participants will receive the lowest dose of study drug. The study team will make sure it is safe and tolerated before enrolling new participants at a higher dose of study drug. There will be up to six or more dose levels of study drug tested (called cohorts). Which dose you receive will depend on how many participants have taken part in the study before you.
The purpose of Part 1 of the study is to evaluate the safety of the study drug at different dose levels, to understand what your body does to the study drug, and to find the best dose of study drug in people who have advanced solid tumor cancers.
In Part 2, participants will receive the best dose level that was determined in Part 1 of the study.
The purpose of Part 2 of the study is to evaluate the safety of the study drug at the dose level determined in Part 1, to understand what your body does to the study drug, and to see how your cancer responds to the study drug.
Participants will:
Participants will have 17 or more visits to the study centre. This study has a screening phase of up to 28 days , and a treatment phase with cycles of 21 days each. Participants will also have an End of Treatment (EOT) visit 21 days after the final study drug treatment, and a Follow-up visit 30 days after the EOT visit . Participants will be contacted by telephone every 3 months after the Follow-up visit to check on the wellbeing and record any new anticancer therapy they may have started.
100 项与 DM-002 (Xadcera Biopharma) 相关的临床结果
100 项与 DM-002 (Xadcera Biopharma) 相关的转化医学
100 项与 DM-002 (Xadcera Biopharma) 相关的专利(医药)
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项与 DM-002 (Xadcera Biopharma) 相关的新闻(医药)1月12日,BioBAY园内企业多玛医药自主研发的1类创新药DM002,HER3/MUC1-C双抗ADC,正式获得美国FDA 新药临床研究申请(IND)批准,即将开启临床一期研究。DM002是多玛医药获得FDA新药临床研究申请批准的第三款双抗ADC产品。
DM002基于靶向肿瘤相关抗原的双靶点策略,针对表皮生长因子受体3(HER3)和黏蛋白1(MUC1)。HER3和MUC1在多种癌症中共同高表达,包括前列腺癌,卵巢癌,子宫内膜癌,胰腺癌,肺癌、乳腺癌、结直肠癌等。DM002通过同时靶向这两个肿瘤相关抗原,可以增加DM002对肿瘤组织的特异性,增加内化,更有效地递送细胞毒素载荷到肿瘤组织,从而使抗肿瘤活性最大化,同时最大限度地减少对健康细胞的伤害,降低毒副作用。
在临床前研究中,DM002展现出强大的抗肿瘤活性和良好的安全性。此外,值得注意的是,在动物实验中,DM002能够显著抑制多种实体肿瘤的生长,且耐受性良好,未见显著毒性反应。这些积极的数据为其临床研究奠定了坚实基础。
即将开展的全球临床一期研究将招募多种类型实体瘤患者,包括前列腺癌,卵巢癌,子宫内膜癌,胰腺癌,小细胞肺癌,结直肠癌和乳腺癌等等,旨在探索不同剂量下的DM002在人体中的安全性、耐受性,并初步评估其抗肿瘤活性。这一阶段的研究结果将为后续的临床研发提供关键数据,推动DM002早日惠及更多肿瘤患者。
“双抗ADC能够通过增加内化和特异性从而增加疗效、减少毒性、规避耐药性,是临床癌症治疗发展的一种新策略,也是近些年来新药研发的热点之一。”多玛医药首席医学官陈兆荣表示,“DM002是多玛医药第三款进入临床阶段的双抗ADC药物,展现了多玛医药强大的研发能力。多玛医药通过创新的治疗手段,为癌症患者提供更多的生存机会和更好的生活质量,也持续为全球癌症治疗领域的发展注入了新动力。”
▌文章来源:多玛医药
责编:何文正
审核:任旭
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100 项与 DM-002 (Xadcera Biopharma) 相关的药物交易