EUCTR2022-001191-34-PL招募中1 期
IL Believe: A Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study to Investigate the Safety and Tolerability of TransCon IL-2 ß/? Alone or in Combination with Pembrolizumab, Standard of Care Chemotherapy, or TransCon TLR7/8 Agonist, or in Combination with Pembrolizumab and Standard of Care Chemotherapy, in Adult Participants with Locally Advanced or Metastatic Solid Tumor Malignancies - IL Believe
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 287
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
- 性别
- All
入选标准
- •-Participants must be at least 18 years of age at the time of signing the informed consent;
- •-Capable of giving signed informed consent;
- •-Archival or newly obtained formalin-fixed tissue of tumor specimen:
- •-Part 3, Cohort 3, 4 and 5: A tumor biopsy sample must be provided at baseline unless deemed unfeasible. A fresh biopsy is preferred, but archival tissue is also acceptable.
- •-Part 3, Cohorts 6a-c and 7: archival tissue or newly obtained formalin-fixed tumor tissue;
- •-Demonstrated adequate organ function at screening drawn within 28 days prior to C1D1;
- •-Life expectancy >12 weeks as determined by the Investigator;
- •-For women of childbearing potential: agreement to remain abstinent.
- •-Part 3 ECOG: 0 or 1
- •-Histologic or cytologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer. Carcinosarcoma, sarcoma, mucinous ovarian cancer, or low-grade serous histologies are excluded;
- •-Must have platinum-resistant ovarian cancer;
- •-participants must be appropriate candidates for treatment with single agent paclitaxel, docetaxel, or pemetrexed at study entry based on treating investigator’s clinical assessment;
- •-At least 1 measurable target lesion as per RECIST 1:1.
- •-Histologically or cytologically confirmed diagnosis of unresectable (stage III) or metastatic (stage IV) cutaneous melanoma who have progressed on anti-PD-1 therapy or had recurrence <6 months after adjuvant anti-PD-1 therapy;
- •-At least 2 target lesions of measurable disease per RECIST 1.1, at least 1 lesion that is safely accessible for intratumoral injection and is also =15 mm in the longest diameter;
- •-Participants may not have liver metastases;
- •- Histologically or cytologically confirmed diagnosis of extra-pelvic metastatic or recurrent cervical cancer with squamous cell, adenocarcinoma or adenosquamous histology who are not candidates for curative therapy.
- •- Have received at least 1, but no more than 2 prior systemic treatment regimens for recurrent or metastatic cervical cancer.
- •- Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody must have evidence of disease progression.
- •- At least 2 target lesions of measurable disease per RECIST 1.1, at least 1 lesion that is safely accessible for intratumoral injection and is also =15 mm in the longest diameter.
- •- Participants may not have liver metastases
- •Cohort 6a-c:
- •-Histologically or cytologically confirmed diagnosis of resectable cutaneous melanoma;
- •-Complete surgical resection must be deemed achievable;
- •-No prior radiotherapy or systemic anticancer therapy for melanoma;
- •-At least one lesion that is safely accessible for intratumoral injection and is also =15 mm in the longest diameter
- •-Histologically or cytologically confirmed NSCLC without EGFR-activating mutations, ALK or ROS1 rearrangements and with completely resectable disease, according to AJCC 8th edition;
- •-Complete surgical resection must be deemed achievable;
- •-No prior radiotherapy or systemic anticancer therapy for NSCLC;
- •-Participants must have adequate cardiopulmonary function;
- •-Evaluable disease with at least 1 measurable target lesion per RECIST 1.1 criteria
- •Other protocol-defined inclusion criteria may apply.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 172
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this ag
排除标准
- •-Symptomatic central nervous system metastases;
- •-Active autoimmune diseases,
- •-Any uncontrolled bacterial, fungal, viral, or other infection;
- •-Significant cardiac disease;
- •-A marked clinically significant baseline prolongation of QT/QTc interval, using Fridericia’s QT correction formula
- •-Positive for HIV or has known active hepatitis B or C infection;
- •-Known hypersensitivity to any study treatment;
- •- Participants who have been previously treated with IL-2 or IL-2 variants (all participants) or TLR agonist, excluding topical agents for unrelated disease (Part 3, Cohorts 4, 5 and 6 ONLY);
- •- Systemic immunosuppressive treatment with the exception for participants on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation);
- •- Vaccination with live, attenuated vaccines within 4 weeks of C1D1.
- •-Women who are breastfeeding or have a positive serum pregnancy test during screening
- •Exclusion Criteria Specific to Part 3 ONLY
- •-Other active malignancies within the last 2 years.
- •Other protocol-defined exclusion criteria may apply.
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