EUCTR2021-001403-33-NL招募中1 期
Phase 1/2, Open-label, Dose Escalation and Dose Expansion Study of TransCon TLR7/8 Agonist Alone or in Combination with Pembrolizumab in Participants with Locally Advanced or Metastatic Solid Tumor Malignancies - transcendIT-101
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 220
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
- •At least 18 years of age.
- •Participants must have histologically confirmed locally advanced, recurrent or metastatic solid tumor malignancies that cannot be treated with curative intent (surgery or radiotherapy), with the exception of participants enrolling to the neoadjuvant cohorts.
- •Participants must have progressed on or be intolerant of available SOC treatment options or have disease for which there is no SOC treatment available, with the exception of participants enrolling to the neoadjuvant cohorts.
- •At least 2 lesions of measurable disease, unless specified otherwise in the selection criteria.
- •Willingness to undergo biopsies.
- •Demonstrated adequate organ function within 28 days of Cycle 1 Day 1 (C1D1).
- •Life expectancy >12 weeks as determined by the Investigator.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2.
- •Participants who have undergone treatment with anti-PD-1, anti-PD-L1, or anti CTLA 4 antibody must have at least 4 weeks from the last dose of antibody and evidence of disease progression per investigator assessment before enrollment.
- •Participants who have previously received an immune checkpoint inhibitor prior to enrollment must have any immune related toxicities resolved to =Grade 1 or baseline (prior to the checkpoint inhibitor) to be eligible.
- •Female and male participants of childbearing potential who are sexually active must agree to use highly effective methods of contraception.
- •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 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 110
排除标准
- •Participants who have been previously treated with a TLR agonist (excluding topical agents for unrelated disease) are not eligible.
- •Other active malignancies within the last 2 years are excluded.
- •Active autoimmune diseases, regardless of need for immunosuppressive treatment at the time of screening, with the exception of patients well controlled on physiologic endocrine replacement.
- •Systemic immunosuppressive treatment with the exception for patients on corticosteroid taper (for example, for chronic obstructive pulmonary disease exacerbation). Participants cannot start dosing on study until steroid dose is at or lower than 10 mg per day prednisone or equivalent.
- •Women who are breastfeeding or have a positive serum pregnancy test during screening or within 72 hours prior to C1D1 are not eligible.
- •Vaccination with live, attenuated vaccines within 4 weeks of enrollment.
- •Symptomatic central nervous system metastases.
- •Known bleeding disorder that is deemed to place the patient at unacceptable risk for bleeding complications from intratumoral injections or biopsies.
- •Known hypersensitivity to any component of TransCon TLR7/8 Agonist or pembrolizumab.
- •Any uncontrolled bacterial, fungal, viral, or other infection.
- •Treatment with any other anti-cancer systemic treatment (approved or investigational) or radiation therapy within 4 weeks of first dosing on study is not allowed.
- •Significant cardiac disease.
- •A marked baseline prolongation of QT/QTc (corrected QT) interval (e.g., repeated demonstration of a QTc interval >480 ms (National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events [CTCAE] grade 1) using Fredericia’s QT correction formula.
- •A history of additional risk factors for Torsades de Pointes (TdP) (e.g., heart failure, clinically significant hypokalemia, family history of Long QT Syndrome).
- •The use of concomitant medications that prolong the QT/QTc interval within 14 days of enrollment.
- •Positive for HIV or with active hepatitis B or C infection.
研究者
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