NL-OMON55468
Completed
Not Applicable
A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination with cemiplimab in Adult Patients with Advanced Solid Tumors - TCD14678
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Advanced solid tumors
- Sponsor
- Genzyme Europe BV
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •Dose escalation (Part 1A and Part 1B):, \-Patients with histologically
- •confirmed, advanced unresectable or metastatic solid tumor whom in the opinion
- •of the Investigator does not have a suitable alternative therapy.,
- •Dose expansion (Part 2A):, \-Patients with histologically confirmed, advanced
- •unresectable melanoma whom in the opinion of the Investigator does not have a
- •suitable alternative therapy
- •\-Patients must have failed any prior therapy based on anti\-PD\-1 or anti\-PD\-L1
- •as defined by disease progression within 26 weeks of initiating anti\-PD\-1 or
- •anti\-PDL\-1\-based therapy without any evidence of a response.
- •\-Patients must have a site of disease amenable to biopsy and be a candidate for
Exclusion Criteria
- •\-Age \< 18 years.
- •\-Eastern Cooperative Oncology Group (ECOG) performance status \>1\.
- •\-Concurrent treatment with any other anticancer therapy (including radiotherapy
- •or investigational agents) or participation in another clinical study.
- •\-Washout period of less than 3 weeks to prior anticancer therapy.
- •\-Significant and uncontrolled concomitant illness, including any psychiatric
- •\-Active infections, including unexplained fever (temperature \>38\.1ºC), or
- •antibiotic therapy within 1 week prior to enrollment.
- •\-Any prior organ transplant including allogeneic bone marrow transplant.
- •\-History within the last 5 years of an invasive malignancy other than the one
Outcomes
Primary Outcomes
Not specified
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