A Phase 1 first- in-human dose escalation and expansion study for the evaluation of safety, pharmacokinetics, pharmacodynamics and anti-tumor activity of SAR441000 administered intratumorally as monotherapy and in combination with cemiplimab in patients with advanced solid tumors - TED15297

Genzyme Europe BV0 个研究点目标入组 11 人开始时间: 待定最近更新: 2024年4月15日

适应症

试验速览

暂无简介。

•For dose escalation phase (monotherapy and combination therapy):
•Subjects must have a diagnosis of Advanced solid tumors including lymphomas for
•which no standard alternative therapy is available
•For dose expansion phase (combination therapy):
•-Subjects must have a diagnosis of Advanced melanoma (Stage IIIB-C or Stage IV,
•anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head
•and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous
•Squamous Cell Cancer where no other alternative treatment option exists.
•Subjects must have a minimum of 3 lesions at enrollment and injectable disease
•(i.e., suitable for direct intratumoral injection based on the dose level
•volume of each cohort and cumulative lesion size; according to the
•investigator*s judgement).
•- A lesion amenable for additional tumor biopsy.
•Additional patients to be included at the end of escalation phase (monotherapy
•combination therapy): Participants with histologically confirmed, advanced
•unresectable or
•metastatic solid tumors expected to be highly immunogenic (such as melanoma,
•HNSCC, SCC,
•or TNBC), who have previously progressed during treatment with
•anti-PD1/anti-PD-L1
•therapies, and who either have already exhausted or declined all available SOCs
•or for whom
•there is a contraindication to available SOCs in the opinion of the
•Investigator.

•- Eastern Cooperative Oncology Group (ECOG) performance score >1.
•- Significant and uncontrolled concomitant illness that would adversely affect
•the patient*s participation in the study.
•- Any prior organ transplantation.
•- History within the last 5 years of an invasive malignancy other than the one
•treated in this study, with the exception of resected basal or squamous-cell
•skin cancer or carcinoma, in situ of cervix or other local tumors considered
•cured by local treatment.
•- Prior splenectomy.
•- New and progressive brain lesions.
•- Poor bone marrow reserve resulting in low blood cell count.
•- Poor liver and kidney functions, abnormal coagulation tests.
•- Ongoing or recent (within 5 years) evidence of significant autoimmune disease
•that required treatment with systemic immunosuppressive treatments.
•- Central nervous system lymphoma
•- Prior allogeneic hematopoietic stem cell transplantation (HSCT) for patients
•with lymphoma.

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