JPRN-jRCT2031230175招募中1 期
This research is designed to determine if experimental treatment with Antibody-drug conjugate, AZD5335, alone, or in combination with anti-cancer agents is safe, tolerable, and has anti-cancer activity in patients with advanced tumors - FONTANA
Hibi Kazushige0 个研究点目标入组 361 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 361
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- Female
入选标准
- •Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.
- •- Provision of signed and dated written Optional Genetic Research Information informed consent prior to collection of samples for optional genetic research that supports Genomic Initiative. Participants who do not provide informed consent for Optional Genetic Research may still be enrolled in the study.
- •- Consent to provide adequate baseline tumor sample, as applicable per module-specific criteria.
- •- Participant must be 18 years or more at the time of signing the informed consent.
- •- Willing to provide archival or baseline tumor sample.
- •- For participants who have previously received targeted therapies such as ADCs, a fresh baseline biopsy will be required.
- •- Eastern Cooperative Oncology Group Performance Status of 0 or 1.
- •- Participants with advanced solid tumors must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease, or, in the opinion of the Investigator, a clinical trial is the best option for the next treatment based on response and/or tolerability to prior therapy. Participants with contraindications or who refuse therapy in accordance with local practice may also be considered provided that it is documented that he/she was informed about all therapeutic options.
- •- Participants must have measurable disease per RECIST v1.1,
- •1. A previously irradiated lesion can be considered a target lesion if the lesion is progressing and well defined.
- •2. For participants who undergo biopsies at screening and/or on treatment, it is preferred though not required, that the biopsied lesion, be distinct from any target lesion used in the RECIST v1.1 evaluation.
排除标准
- •- Patients with spinal cord compression or a history of leptomeningeal carcinomatosis.
- •- Patients with brain metastases unless, asymptomatic, stable, and not requiring continuous corticosteroids at a dose of > 10 mg prednisone/day or equivalent for at least 4 weeks prior to first dose of study intervention.
- •- Treatment with any of the following, without adequate washout periods or time before the first dose of study intervention.
- •- Unresolved toxicities of Grade 2 or more (National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE] v5.0) from prior therapy (excluding vitiligo, alopecia, and endocrine disorders that are controlled with replacement hormone therapy). Participants with stable Grade 2 or less neuropathy are eligible.
- •- Active infection, including tuberculosis and infections with hepatitis B virus (HBV; verified by known positive hepatitis B surface antigen [HBsAg] result), hepatitis C virus (HCV) or known HIV infection that is not well controlled. All of the following criteria are required to define an HIV infection that is well controlled: undetectable viral RNA, CD4+ count 350/mm3 or more, no history of acquired immune deficiency syndrome-defining opportunistic infection within the past 12 months, and stable for at least 4 weeks on the same anti-HIV medications (meaning there are no expected further changes in that time to the number or type of antiretroviral drugs in the regimen).
- •Patients with a past or resolved HBV/HCV infection are eligible if:
- •(a) Negative for HBsAg and positive for anti-HBc or
- •(b) Are HBsAg + with chronic HBV infection (lasting 6 months or longer) and meet conditions i-iii below:
- •(i) HBV DNA viral load <100 IU/mL.
- •(ii) Have normal transaminase values, or, if liver metastases are present, abnormal transaminases, with a result of AST/ALT <3 x ULN, which are not attributable to HBV infection.
- •(iii) Start or maintain antiviral treatment if clinically indicated as per the Investigator or as per local guideline.
- •Note for Japan: Japanese patients with positive anti-HBs/anti-HBc and negative HBsAg will be assessed following local guidelines.
- •(c) Participants testing positive for HCV antibody are eligible only if the polymerase chain reaction test result is negative for HCV RNA.
- •- Patient has ILD/pneumonitis or has a history of (non-infectious) ILD/pneumonitis that required oral or IV steroids or supplemental oxygen, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- •- Patients with a history of radiation pneumonitis which has clinically and radiologically resolved and not requiring treatment with steroids may be eligible.
- •- History of another primary malignancy except for:
- •_Malignancy treated with curative intent and with no known active disease for at least 2 years prior to screening of study intervention and with low potential risk for recurrence.
- •_Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease.
- •_Adequately treated carcinoma in situ without evidence of disease.
- •_Localized non-invasive primary disease under surveillance.
- •- Patients with any of the following cardiac criteria:
- •_History of arrhythmia (such as multifocal premature ventricular contractions, bigeminy, trigeminy, and ventricular tachycardia), which is symptomatic or requires treatment (NCI CTCAE v5.0 Grade 3); symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia.
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