NL-OMON56170招募中2 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 - TransCon TLR7/8 Agonist in Advanced Solid Tumor Malignancies
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 7
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
- •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
- •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.
- •Specific Inclusion Criteria for Part 1:
- •Participants with any solid tumor malignancies who are deemed by the
- •investigator to be refractory to or intolerant of existing therapies known to
- •provide clinical benefit.
- •Participants should have visible or easily palpable lesions to enable early
- •assessment of injection site reactions.
- •Specific Inclusion Criteria for Part 2:
- •Participants with histologically confirmed tumor types where there is
- •expected clinical activity of pembrolizumab in the advanced treatment setting
- •will be enrolled.
- •Participation in this clinical study must be deemed by the investigator to be
- •in the best interest of the patient compared to any other available therapies.
- •Participants must have received no more than 2 lines of therapy or treatment
- •regimens for locally advanced, unresectable, recurrent or metastatic disease.
- •Specific Inclusion Criteria for Part 3 (Indication-Specific Dose Expansion
- •Specific Inclusion Criteria for HNSCC (Cohort 3a):
- •Histologically confirmed squamous cell cancers, regardless of HPV or PD-L1
- •Known HPV (for example, p16 immunohistochemistry, IHC) status.
- •Participants must have received no more than 1 prior line of
- •chemotherapy-based treatment for locally advanced, unresectable, recurrent or
- •metastatic disease.
- •Specific Inclusion Criteria for Other HPV-associated Tumor Types (Cohort 3b):
- •Histologically confirmed anal, vulvar, cervical, penile or vaginal cancers.
- •Known HPV (for example, p16 IHC) status.
- •Participants must have received no more than 1 prior line of therapy or
- •treatment regimen for locally advanced, unresectable, recurrent or metastatic
- •Specific Inclusion Criteria for Neoadjuvant Melanoma (Cohort 3c):
- •Histologically or cytologically confirmed diagnosis of cutaneous melanoma.
- 另有 1 项未显示
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
- •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.
- •Specific Exclusion Criteria for Part 3 (Indication-Specific Dose Expansion
- •Specific Exclusion Criteria for Neoadjuvant Melanoma (Cohort 3c)
- •Disease that is deemed unresectable is excluded.
- •Participants with acral/lentiginous, mucosal, or uveal melanoma are excluded.
- •Specific Exclusion Criteria for Neoadjuvant cSCC (Cohort 3d)
- •Patients whose tumor burden, or pace of tumor growth, in the opinion of the
- •Principal Investigator will not permit delaying surgery.
- •Previous solid organ transplantation or bone marrow transplantation.
研究者
相似试验
招募中
1 期
A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumorsocally advanced or metastatic solid tumor malignanciesMedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2021-001403-33-NLAscendis Pharma Oncology Division A/S220
进行中（未招募）
1 期
A Study of TransCon TLR7/8 Agonist With or Without Pembrolizumab in Patients With Advanced or Metastatic Solid Tumorsocally advanced or metastatic solid tumor malignanciesMedDRA version: 21.0Level: LLTClassification code 10049280Term: Solid tumourSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10065143Term: Malignant solid tumourSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10065147Term: Malignant solid tumorSystem Organ Class: 100000004864MedDRA version: 21.1Level: LLTClassification code 10065252Term: Solid tumorSystem Organ Class: 100000004864EUCTR2021-001403-33-HUAscendis Pharma Oncology Division A/S220
进行中（未招募）
1 期
A study to evaluate Infigratinib in children with AchondroplasiaAchondroplasia in ChildrenMedDRA version: 20.0Level: LLTClassification code 10000452Term: AchondroplasiaSystem Organ Class: 100000004850EUCTR2019-002954-21-GBQED Therapeutics, Inc.78
进行中（未招募）
1 期
A study to evaluate Infigratinib in children with AchondroplasiaAchondroplasia in ChildrenMedDRA version: 20.0Level: LLTClassification code 10000452Term: AchondroplasiaSystem Organ Class: 100000004850EUCTR2019-002954-21-FRQED Therapeutics, Inc.60
招募中
1 期
A study to investigate the short- and long-term safety and tolerability of the drug SNDX-5613 in Patients with Relapsed/Refractory Leukemias. Various doses of SNDX-5613 will be investigated.Relapsed or Refractory Acute LeukemiasEUCTR2020-004104-34-ITSYNDAX PHARMACEUTICALS, INC.333