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 - ASND0029

Ascendis Pharma Oncology Division A/S0 个研究点目标入组 417 人开始时间: 2023年11月16日最近更新: 2024年8月21日

适应症

试验速览

阶段: 1 期
状态: 招募中
发起方: Ascendis Pharma Oncology Division A/S
入组人数: 417

研究概览入排标准研究者记录与标识符相似试验

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 65+（—）
性别: All

入选标准

•At least 18 years of age • Adequate organ function at screening Part 1 and Part 2: Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 Part 3 or Part 4 : ECOG performance status of 0 or 1, Part 2 and Part 4: • Tumor types where there is expected clinical activity of pembrolizumab in the advanced treatment setting and where participation in this clinical study is deemed by the investigator to be in the best interest of the participant compared to any other available therapies • No more than 2 lines of therapy or treatment regimens for locally advanced, unresectable, recurrent or metastatic disease, PROC (Cohort 3): • Female participants with histologic or cytologic documentation of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer • Must have PROC platinum-resistant ovarian cancer , defined as cancer progression within 6 months after completion of prior platinum-based therapy (at least 3 cycles) • At least 1 target lesion of measurable disease per RECIST 1.1, Post-PD-1 Melanoma (Cohort 4): • Must have unresectable (stage III) or metastatic (stage IV) melanoma who have progressed on anti-PD-1 therapy or had recurrence <6 months after adjuvant anti-PD-1 therapy • Progression must be determined according to RECIST 1.1 while on anti-PD-1 therapy or within 3 months of the last dose of anti-PD-1 therapy • At least 1 target lesion of measurable disease per RECIST 1.1 2L+, Metastatic Cervical Cancer (Cohort 5): • Must have 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. Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy should not be counted as a prior systemic treatment regimen for recurrent or metastatic disease • At least 1 target lesion of measurable disease per RECIST 1.1, Neoadjuvant Melanoma (Cohorts 6a-c): • Histologically or cytologically confirmed diagnosis of resectable cutaneous melanoma belonging to one of the following American Joint Committee on Cancer (AJCC) version 8 Tumor Node Metastasis (TNM) stages: Tx or T1-4 and N1b, or N1c, or N2b, or N2c, or N3b, or N3c and M0 • No prior radiotherapy or systemic anticancer therapy for melanoma • For Cohort 6c, participants must have at least one safely accessible lesion for IT injection of TransCon TLR7/8 Agonist that is =15 mm in the longest diameter, Neoadjuvant NSCLC (Cohort 7): • Histologically or cytologically confirmed NSCLC and must be ineligible for actionable and available targeted therapy (e.g., EGFR mutations, ALK rearrangement, ROS rearrangements, or BRAF V600E mutation) and with completely resectable disease (tumors =4 cm or node positive) • No prior radiotherapy or systemic anticancer therapy for NSCLC • Evaluable disease with at least 1 measurable target lesion per RECIST 1.1 criteria, Post anti-PD-(L)1 NSCLC (Cohort 8): • Histologically or cytologically confirmed diagnosis of metastatic (stage IV) squamous or nonsquamous NSCLC • Must have progression of disease following treatment with platinum-based chemotherapy in addition to anti-PD(L)-1. • Must have received or be ineligible for actionable and available targeted therapy (e.g., EGFR mutations, ALK rearrangement, ROS rearrangement, or BRAF V600E mutation). • Progression must be dete

排除标准

•Prior treatment with IL-2 and variants (all participants) or TLR agonist (Part 3, Cohorts 4, 5, and 6c only) •Active autoimmune conditions •Significant cardiac disease •Symptomatic central nervous system metastases

研究者

发起方

Ascendis Pharma Oncology Division A/S

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