The Primary Objective was:
-To determine the antitumor activity of SAR444245 in combination with other anticancer
therapies.
The Secondary Objectives were:
- To confirm the dose and to assess the safety profile of SAR444245 when combined with
other anticancer therapies.
- To assess other indicators of antitumor activity.
- To assess the pharmacokinetic (PK) profile of SAR444245 when given in combination
with pembrolizumab.
- To assess the immunogenicity of SAR444245.
Additional locations may be listed on ClinicalTrials.gov for NCT04914897.
See trial information on ClinicalTrials.gov for a list of participating sites.
The duration of the study for an individual participant started from the signature of the
main informed consent and included a screening period of up to 28 days, a treatment
period [max 35 cycles {cohorts A1, A2, and B1} = 735 days or until PD {cohort C1}], an
end-of-treatment visit at least 30 days following the last administration of study drug
(or until the participant 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
Lead OrganizationSanofi Aventis