NL-OMON55221
Completed
Not Applicable
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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced solid tumors
- Sponsor
- Genzyme Europe BV
- Enrollment
- 11
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •\- 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.
Outcomes
Primary Outcomes
Not specified
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