NL-OMON51302撤回2 期
A Phase 1b/2a, Open-Label, Multi-Center Study of CyPep-1 in Combination With Pembrolizumab to Evaluate the Efficacy and Safety of CyPep-1 in Patients With Advanced or Metastatic Head and Neck Squamous Cell Carcinoma (HNSCC), Melanoma, or Triple-Negative Breast Cancer (TNBC) (CATALYST) - CYP003 - CATALYST
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 12
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
- 18 至 99（—）
入选标准
- •General Inclusion Criteria
- •Patients who meet all of the following criteria will be eligible to participate
- •in the study:
- •1. Are 18 years of age or older on the day of signing informed consent;
- •2. Provide written informed consent and are able to comply with study
- •procedures and assessments;
- •3. Have measurable disease per Response Evaluation Criteria in Solid Tumors
- •(RECIST) version (v)1.1 as assessed by the local site Investigator/radiology.
- •Lesions situated in a previously irradiated area are considered measurable if
- •progression has been demonstrated in such lesions;
- •4. Have at least 1 non-ulcerated, measurable, and accessible lesion for
- •intra-tumoral (IT) injection with a maximum diameter of 5 cm;
- •5. Are able to provide tissue from a core or excisional biopsy at screening or
- •have an acceptable stored tumor sample available that was collected within 90
- •days prior to screening;
- •6. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •7. Have a life expectancy *3 months, as determined by the Investigator;
- •8. Female patients of non-childbearing potential must be either surgically
- •sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or
- •bilateral oophorectomy at least 26 weeks before screening), post-menopausal,
- •defined as spontaneous amenorrhea for at least 2 years, or with
- •follicle-stimulating hormone in the post-menopausal range at screening;
- •9. Female patients of childbearing potential (defined as <2 years after last
- •menstruation or not surgically sterile) must have a negative serum pregnancy
- •test at screening and agree to use a highly effective method for contraception
- •from the time of signing the informed consent form (ICF) until at least 120
- •days after the last administration of study treatment. Highly effective methods
- •of contraception are birth control methods with a failure rate of <1% per year
- •used consistently and correctly, including the following:
- •o Combined estrogen- and progestin-containing hormonal contraception associated
- •with inhibition of ovulation given orally, intravaginally, or transdermally;
- •progestin-only
- •hormonal contraception associated with inhibition of ovulation given orally, by
- •or by implant; intrauterine devices; and intrauterine hormone-releasing
- •o Female sterilization (surgical bilateral oophorectomy with/without
- •hysterectomy, total hysterectomy, bilateral tubal occlusion/ligation) at least
- •26 weeks prior to first study
- •o Sterilization of male partner (at least 6 months prior to first study
- •treatment dose); and
- •o Complete sexual abstinence. Periodic abstinence (eg, calendar) and withdrawal
- •are not acceptable. Sexual abstinence is considered a highly effective method
- •only if defined as refraining from heterosexual intercourse during the entire
- •period of risk associated with the study treatment. The reliability of sexual
- •abstinence needs to be evaluated in relation to the duration of the study and
- •the preferred and usual lifestyle of the patient.
- •10. Male patients able to father children must agree to use 2 acceptable
- •methods of contraception throughout the study (eg, condom plus spermicidal
- •gel). Sperm donation is not recommended from the time of signing the ICF until
- •at least 120 days after the last administration of study
排除标准
- •Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from
- •participation in the study:
- •1. Have only non-palpable cutaneous infiltrations (eg, breast cancer cutaneous
- •carcinomatosis);
- •2. Have had anti-cancer therapy within 4 weeks prior to the first dose of study
- •treatment (2 weeks for palliative radiotherapy);
- •Note: Patients must have recovered from all adverse events (AEs) due to
- •previous therapies to <= Grade 1 or baseline (alopecia is an allowable
- •exception). Upon discussion with the Sponsor, patients with <= Grade 2
- •neuropathy or endocrine-related AEs requiring treatment or hormone replacement
- •may be eligible.
- •Note: If the patient had major surgery, the patient must have recovered
- •adequately from the
- •procedure and/or any complications from the surgery prior to starting study
- •intervention.
- •3. Have participated in a clinical trial and received an investigational
- •therapy within 30 days prior to the first dose of study treatment;
- •4. Have received or will receive a live or live attenuated vaccine within 30
- •days prior to the first dose of study treatment;
- •Note: Seasonal flu vaccines that do not contain live vaccine are permitted.
- •Coronavirus Disease 2019 (COVID-19) vaccines are only permitted with
- •documentation of the date of the vaccine if the last dose of vaccine was
- •administered >14 days prior to the first dose of study treatment. The COVID-19
- •booster vaccine must be administered at least 14 days prior to the first dose
- •of study treatment and is not allowed during the first 3 months of the
- •Treatment Period.
- •5. Have tested positive for severe acute respiratory syndrome coronavirus 2
- •(SARS-CoV-2) infection within 14 days prior to the Screening Visit;
- •Note: Patients who have had a known SARS-CoV-2 infection >14 days prior to the
- •Screening Visit are permitted at Investigator discretion and must present with
- •no symptoms.
- •6. Have had a major surgical procedure within 14 days prior to the first dose
- •of study treatment;
- •7. Are expected to require a systemic or localized anti-neoplastic therapy
- •during participation in
- •this study, excluding localized palliative radiotherapy to tumors not selected
- •for evaluation of treatment response;
- •Note: Use of denosumab for patients with bone metastasis is allowed.
- •8. Are pregnant or breastfeeding;
- •9. Have clinical evidence of a secondary malignancy actively progressing or
- •requiring active treatment other than curative therapies for early stage
- •(carcinoma in situ or Stage 1) carcinomas or non-melanoma skin cancer;
- •10. Have had any autoimmune disease requiring immunosuppressive therapy (ie,
- •use of disease modifying agents, corticosteroids, or immunosuppressive drugs)
- •within 2 years prior to the first dose of study treatment;
- •Note: Replacement therapy (eg, thyroxine, insulin, or physiologic
- •corticosteroid replacement therapy for adrenal or pituitary insufficiency) is
- •not considered a form of systemic treatment and is allowed.
- •11. Have a condition requiring continuous systemic treatment with either
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研究者
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