CTIS2024-511884-27-00招募中1 期
A Phase I/Ib, open-label, dose finding study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of OBT076, a CD205-directed antibody-drug conjugate, in recurrent and/or metastatic CD205-positive solid tumors - OBT076-001
Oxford Biotherapeutics Limited0 个研究点目标入组 170 人开始时间: 2024年3月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 170
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patient is = 18 years of age (at the time of signing the ICF) with non-curative recurrent and/or metastatic solid tumors who have progressed on standard treatments or for which a standard therapy is not available or is no longer effective, or who has no satisfactory treatment options., Patient understands and voluntarily signs an ICF prior to any study-related assessments/procedures are conducted., Patient is able to adhere to the study visit schedule and other protocol requirements., Patient is a female of childbearing potential [defined as a sexually mature woman] who 1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time during the preceding 12 consecutive months)] and is using any adequate form of birth control must: a.have a negative pregnancy test within 1 week before first dose of study drug b.use highly effective method(s) of birth control consistently and correctly during the study and for at least 4 months after the last dose of study drug (See Section 21: Birth control methods which may be considered as highly effective – CTFG Version 1.1) c.agree to not donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 4 months after the last dose of study d.agree to no plan to breastfeed and no plan to become pregnant during the study and for at least 4 months after the last dose of study drug, Patient is a male who is sexually active must: a.agree to use a condom with spermicidal foam/gel/film/cream/suppository during the study and for at least 4 months after the last dose of study drug b.agree to not donate sperm during the study and for at least 4 months after the last dose of study drug c.no plan to father a child during the study or within 4 months after the last dose of study drug, Patient has histologically and/or cytologically confirmed solid tumors. The following tumor specific restrictions apply for all study parts (please note that specific tumor types may not be eligible for specific study parts and/or cohorts), Breast cancer: a)Patients with hormone-receptor positive (as per local laboratory) recurrent locally advanced or metastatic breast cancer, regardless of HER2 status, must have received at least two prior lines of endocrine therapy in the adjuvant or metastatic setting, either as monotherapy or in combination with targeted therapy as e.g., CDK4/6 or PIK3CA inhibitors. For pre- or peri-menopausal patients LHRH agonists are allowed. b)For patients with recurrent locally advanced or metastatic non-curative HER2 negative breast cancer (based on most recently analyzed biopsy), HER2 status is defined as per ASCO-CAP guidelines as negative, if in situ hybridization test or IHC status is 0, 1+, or 2+. If IHC is 2+, then a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. c)Patients with triple negative breast cancer are eligible after at least one prior line of cytotoxic chemotherapy in the metastatic setting. d)Prior adjuvant or neoadjuvant chemotherapy allowed., Patient has received a maximum of two prior lines of cytotoxic chemotherapy in the metastatic setting., Patient has tumor that is positive for CD205 antigen (? 2+ in >50% of tumor cells by IHC staining). Note: The CD205 assay is a laboratory developed test, validat
排除标准
- •Patient has received any cytotoxic chemotherapy within 28 days prior to Cycle 1 Day 1., Patient has any other malignancy within 5 years prior to signature of ICF, with the exception of any curable cancer with a complete response of >2 years duration that does not require or is not anticipated to require any additional therapy. Patients with adequately treated in situ carcinoma of the cervix, uterus, or non-melanomatous skin cancer (all treatment of which should have been completed 6 months prior to enrollment), are eligible for the study., Patient has a known or suspected hypersensitivity or other contraindication to any excipients used in the manufacture of OBT076 or balstilimab., Patient has any significant medical condition, laboratory abnormality, or psychiatric illness that would, in the Investigator’s judgment, contraindicate patient participation in the study (e.g., history of thromboembolic event, cardiac dysfunction, chronic pancreatitis, chronic active hepatitis)., Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine <7 days before Cycle 1 Day 1. For vaccines requiring more than 1 dose, the full series should be completed prior to Cycle 1 Day1, when feasible., Patient has any condition that confounds the ability to interpret data from the study., Patient is lactating or breastfeeding., Patient has a past medical history of or ongoing clinically relevant interstitial lung disease, drug-induced pneumonitis or severe/very severe COPD., Patient has active or chronic corneal disorder or Sjogren’s syndrome., Patient has any ongoing skin disorders not controlled by specific treatment., Patient has significant active cardiac disease within the previous 6 months including unstable angina or angina requiring surgical or medical intervention, significant cardiac arrhythmia, or NYHA class 3 or 4 congestive heart failure., Patient has received any other systemic anticancer therapy within 28 days or 5 half-lives of Cycle 1 Day 1, whichever is shorter (patients receiving endocrine/hormonal treatment for respective tumor types are eligible)., Patient has a known history or current diagnosis of HIV infection, unless on triple antiviral treatment with undetectable viral load., Patient has any condition that confounds the ability to interpret data from the study., Patient is a female of childbearing potential [defined as a sexually mature woman who 1) has not undergone hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries) or 2) has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time during the preceding 12 consecutive months)] and is not using any adequate form of birth control., Patient is unable or unwilling to take folic acid or vitamin B12 supplementation., History of allogeneic organ transplant., Patients with grade 3 or 4 immune-related adverse reactions during any prior line of checkpoint inhibitor containing therapy. Patients with immune-related thyroiditis controlled with substitution, or prior asymptomatic lipase increases are eligible for the study., Active autoimmune disease or history of autoimmune disease that required systemic treatment within 3 years of the start of study treatment (i.e. with use of disease-modifying agents or immunosuppressive drugs)., Patient has symptomatic visceral crisis requiring chemotherapy per Investigator judgment for non TNBC, Patients with colorectal cancer and pancreatic ca
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