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Spots Global Cancer Trial Database for A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

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Trial Identification

Brief Title: A First-in-human Study of the Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR439459 Monotherapy and Combination of SAR439459 and Cemiplimab in Patients With Advanced Solid Tumors

Official Title: 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

Study ID: NCT03192345

Study Description

Brief Summary: Primary Objectives: Dose escalation (Part 1) Part 1A (SAR439459 monotherapy) * To determine the maximum tolerated dose (MTD) and/or maximum administered dose (MAD) of SAR439459 when administered intravenously as monotherapy in adult patients with advanced solid tumors. Part 1B (SAR439459 and cemiplimab combination therapy) * To determine the MTD and/or MAD of SAR439459 administered intravenously in combination with cemiplimab administered intravenously in adult patients with advanced solid tumors. Dose expansion (Part 2) Part 2A (SAR439459 monotherapy) * To determine optimal dose of SAR439459 administered intravenously in adult patients with advanced melanoma who have failed a prior therapy based on anti-PD-1 (programmed cell death-1) or anti-PD-L1. Part 2B (SAR439459 and cemiplimab combination therapy) * To determine the objective response rate (ORR) of SAR439459 in combination with cemiplimab in adult patients with selected advanced solid tumors by evaluation of antitumor response according to Response Evaluation Criteria in Solid Tumors 1.1 (RECIST 1.1). Secondary Objectives: * Pharmacokinetic (PK) profile SAR439459 monotherapy and combined with cemiplimab, PK profile of cemiplimab combined with SAR439459. * Immunogenicity of SAR439459 monotherapy and combined with cemiplimab. Dose escalation (Part 1) * Overall safety/tolerability profile of SAR439459 monotherapy and combined with cemiplimab. * Preliminary recommended phase 2 dose (pRP2D) of SAR439459 as monotherapy or combined with cemiplimab. Dose expansion (Part 2) * Progression free survival (PFS), time to progression (TTP), ORR, and safety of SAR439459 as monotherapy and PFS, TTP, duration of response (DOR), disease control rate (DCR) and safety in combination with cemiplimab. * To confirm the optimal dose of SAR439459 administered in combination with cemiplimab.

Detailed Description: The duration of the study for an individual patient will start from the signature of the main informed consent and include a screening period of up to 4 weeks (28 days), a treatment period of at least 1 or 2 cycles (21 or 14 days per cycle, respectively), an end-of-treatment visit at least 30 days following the last administration of study drug (or until the patient receives another anticancer therapy, whichever is earlier), and a follow-up visit 3 months after treatment discontinuation and every 3 months following, until disease progression, or initiation of another antitumor treatment, or death, whichever is earlier. For the urothelial cancer cohort in Part 2B, follow-up visits will occur every 3 months until death, study cut-off date, or upon cancellation of Survival follow-up at the discretion of the Sponsor at any prior timepoint. For the overall survival analysis (approximately 12 months after last patient first dose), whichever comes first. Patients who have no disease progression, and continue to benefit from the study drug(s), will be allowed to continue treatment beyond the common study end-date at their assigned dose unless the study is terminated by the Sponsor. The expected enrollment period is approximately 42 months.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Investigational Site Number :8400007, Duarte, California, United States

Investigational Site Number :8400004, Fairway, Kansas, United States

Investigational Site Number :8400001, Boston, Massachusetts, United States

Investigational Site Number :8400101, Boston, Massachusetts, United States

Investigational Site Number :8400008, Durham, North Carolina, United States

Investigational Site Number :8400006, Nashville, Tennessee, United States

Investigational Site Number :8400003, Dallas, Texas, United States

Investigational Site Number :0360002, Heidelberg West, Victoria, Australia

Investigational Site Number :0360001, Melbourne, Victoria, Australia

Investigational Site Number :0560002, Bruxelles, , Belgium

Investigational Site Number :0560001, Leuven, , Belgium

Investigational Site Number :1240003, Calgary, Alberta, Canada

Investigational Site Number :1240001, Toronto, Ontario, Canada

Investigational Site Number :1240002, Montreal, Quebec, Canada

Investigational Site Number :2330001, Tallinn, , Estonia

Investigational Site Number :2500006, Lille, , France

Investigational Site Number :2500002, Marseille, , France

Investigational Site Number :2500003, Nantes, , France

Investigational Site Number :2500005, Nantes, , France

Investigational Site Number :2500004, Paris, , France

Investigational Site Number :2500001, Villejuif, , France

Investigational Site Number :2760001, Essen, , Germany

Investigational Site Number :2760003, Hannover, , Germany

Investigational Site Number :3800003, Rozzano, Milano, Italy

Investigational Site Number :3800001, Milano, , Italy

Investigational Site Number :3800002, Milano, , Italy

Investigational Site Number :4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number :4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number :5280005, Nijmegen, , Netherlands

Investigational Site Number :5280001, Rotterdam, , Netherlands

Investigational Site Number :5280002, Utrecht, , Netherlands

Investigational Site Number :7240002, Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :7240001, Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :7240006, Barcelona, Barcelona [Barcelona], Spain

Investigational Site Number :7240003, Madrid / Madrid, Madrid, Comunidad De, Spain

Investigational Site Number :7240004, Madrid / Madrid, Madrid, Comunidad De, Spain

Investigational Site Number :7240005, Pamplona, Navarra, Spain

Investigational Site Number :1580003, Kaohsiung, , Taiwan

Investigational Site Number :1580002, Tainan, , Taiwan

Investigational Site Number :1580001, Taipei 100, , Taiwan

Investigational Site Number :8260001, Glasgow, Central Bedfordshire, United Kingdom

Investigational Site Number :8260002, Cardiff, Vale Of Glamorgan, The, United Kingdom

Contact Details

Name: Clinical Sciences & Operations

Affiliation: Sanofi

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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