Spots Global Cancer Trial Database for Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
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: Dose Escalation and Expansion Study of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors
Official Title: A Phase 1/1b Open-label, First-in-human, Single Agent, Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR443216 in Participants With Relapsed/Refractory HER2 Expressing Solid Tumors.
Study ID: NCT05013554
Study Description
Brief Summary: Primary Objectives: Part 1 (Dose Escalation) * To determine the MTD/maximum administered dose (MAD) of SAR443216 administered as a single agent in participants with HER2 expressing solid tumors and determine the RD(s) for intravenous (IV) and subcutaneous (SC) administration in the dose escalation part. * To determine the safety of SAR443216 after intravenous (IV) and subcutaneous (SC) administration. Part 2 (Dose expansion) • To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Secondary Objectives: Part 1 • To assess preliminary clinical activity of single agent SAR443216 after IV and SC administration at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression. Part 2 • To determine the safety of SAR443216. Part 1 and 2 * To characterize the pharmacokinetic (PK) profile of SAR443216 when administered as a single agent after IV and SC (Part 1 only) administration. * To evaluate the immunogenicity of SAR443216 after IV and SC administration. * To assess preliminary clinical activity of single agent SAR443216 at the RD(s) in participants with HER2 expressing solid tumors, with various levels of HER2 expression.
Detailed Description: The expected duration of study intervention for participants may vary, based on progression date; median expected duration of study per participant is estimated to be: * 7.5 months (up to 1 month for screening, a median of 3.5 months for treatment, and a median of 3 months for long term follow-up) in escalation. * 9.5 months (up to 1 month for screening, a median of 5.5 months for treatment, and a median of 3 months for long term follow-up) in expansion.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
~University of Texas - MD Anderson Cancer Center Site Number : 8400002, Houston, Texas, United States
Investigational Site Number : 0560002, Gent, , Belgium
Investigational Site Number : 2500001, Pierre Benite, , France
Investigational Site Number : 2500002, Villejuif, , France
Investigational Site Number : 4100001, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 4100002, Seoul, Seoul-teukbyeolsi, Korea, Republic of
Investigational Site Number : 7240003, Barcelona, Barcelona [Barcelona], Spain
Investigational Site Number : 7240002, Madrid / Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 7240001, Madrid, Madrid, Comunidad De, Spain
Investigational Site Number : 1580001, Taichung City, , Taiwan
Investigational Site Number : 1580002, Tainan, , Taiwan
Contact Details
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
