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Journal: Anti-drug antibodies and drug development: challenges in the immunotherapy era. (Pubmed Central) - Jan 1, 2022
LY3415244, a novel TIM3-PDL1 bispecific caused neutralizing antidrug antibodies (ADAs) in 12 out of 12 patients and required study termination. Novel approaches are needed to ameliorate and manage this undesirable effect of therapeutic antibodies.
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Enrollment change, Trial termination, Metastases: A Study of LY3415244 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Nov 15, 2019
P1a/1b, N=12, Terminated,
Novel approaches are needed to ameliorate and manage this undesirable effect of therapeutic antibodies. N=117 --> 12 | Active, not recruiting --> Terminated; The study was terminated during dose escalation after a determination was made that the risk:benefit ratio no longer favored continued evaluation.
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Enrollment closed, Metastases: A Study of LY3415244 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Sep 16, 2019
P1a/1b, N=117, Active, not recruiting,
N=117 --> 12 | Active, not recruiting --> Terminated; The study was terminated during dose escalation after a determination was made that the risk:benefit ratio no longer favored continued evaluation. Recruiting --> Active, not recruiting
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Trial completion date, Trial primary completion date, Metastases: A Study of LY3415244 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Sep 4, 2019
P1a/1b, N=117, Recruiting,
Recruiting --> Active, not recruiting Trial completion date: Oct 2020 --> Oct 2019 | Trial primary completion date: Oct 2020 --> Oct 2019
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Enrollment open, Metastases: A Study of LY3415244 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - Nov 28, 2018
P1a/1b, N=117, Recruiting,
Trial completion date: Oct 2020 --> Oct 2019 | Trial primary completion date: Oct 2020 --> Oct 2019 Not yet recruiting --> Recruiting
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