⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: A Study of SAR444245 Combined With Other Anticancer Therapies for the Treatment of Participants With Gastrointestinal Cancer (Master Protocol) (Pegathor Gastrointestinal 203)

Official Title: A Phase 2 Non-randomized, Open-label, Multi-cohort, Multi-center Study Assessing the Clinical Benefit of SAR444245 (THOR-707) Combined With Other Anticancer Therapies for the Treatment of Participants With Advanced and Metastatic Gastrointestinal Cancer

Study ID: NCT05104567

Study Description

Brief Summary: The study is a phase 2 non-randomized, open-label, multi-cohort, multi-center study assessing the clinical benefit of SAR444245 (THOR-707) combined with other anticancer therapies for the treatment of participants aged 18 years and older with advanced and metastatic gastrointestinal cancer. This study is structured as a master protocol for the investigation of SAR444245 with other anticancer therapies. Sub study 01 - Cohort A aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). Sub study 02 - Cohort B1, B2 and B3 would focus on non MSI-H tumors with a large unmet need to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic gastric cancer or gastro-esophageal junction adenocarcinoma (GC/GEJ), especially with low PD-L1 expression or after progression on prior PD1/PD-L1-based regimens. Sub study 03 - Cohort C aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with the anti-PD1 antibody pembrolizumab will result in a significant increase in the percentage of patients experiencing an objective response in participants with advanced unresectable or metastatic HCC who relapsed on prior PD1/PD-L1-based regimens. Sub study 04 - Cohort D1 and D2 aims to establish proof-of-concept that combining the non-alpha-IL2 SAR444245 with either the anti-PD1 antibody pembrolizumab or with the anti-EGFR IgG1 antibody cetuximab will result in a significant increase in the percentage of patients experiencing an objective response in the setting of advanced unresectable or metastatic colorectal cancer (mCRC).

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 28 days, a treatment period \[max 35 cycles {cohort A; B1,B2, B3, C and D1} = 735 days or until PD {cohort D2}\], 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

City of Hope Site Number : 8400007, Duarte, California, United States

AdventHealth Orlando Site Number : 8400005, Orlando, Florida, United States

Seattle Cancer Care Alliance Site Number : 8400009, Seattle, Washington, United States

Investigational Site Number : 0560002, Bruxelles, , Belgium

Investigational Site Number : 0560003, Edegem, , Belgium

Investigational Site Number : 0560001, Leuven, , Belgium

Investigational Site Number : 1520001, Santiago, Reg Metropolitana De Santiago, Chile

Investigational Site Number : 1560002, Wuhan, , China

Investigational Site Number : 2500004, Bordeaux, , France

Investigational Site Number : 2500006, Brest, , France

Investigational Site Number : 2500002, Paris, , France

Investigational Site Number : 2500005, Poitiers, , France

Investigational Site Number : 2500001, Villejuif, , France

Investigational Site Number : 3800001, Rozzano, Lombardia, Italy

Investigational Site Number : 3800003, Milano, , Italy

Investigational Site Number : 3800002, Milano, , Italy

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

Investigational Site Number : 4100004, Seoul, Seoul-teukbyeolsi, Korea, Republic of

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

Investigational Site Number : 4100003, Seoul, Seoul-teukbyeolsi, Korea, Republic of

Investigational Site Number : 5280001, Amsterdam, , Netherlands

Investigational Site Number : 5280003, Rotterdam, , Netherlands

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

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

Investigational Site Number : 7240005, Santander, Cantabria, Spain

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

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

Investigational Site Number : 7240101, Madrid, Madrid, Comunidad De, Spain

Investigational Site Number : 7240001, Pamplona, Navarra, Spain

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: