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1 Trial |  |
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- || TAK-164 / Takeda
P1 data, Clinical Trial,Phase I, Journal, Metastases: A phase I, first-in-human study of TAK-164, an antibody-drug conjugate, in patients with advanced gastrointestinal cancers expressing guanylyl cyclase C. (Pubmed Central) - Apr 4, 2023
P1
TAK-164 appeared to have a manageable safety profile at 0.064
- || TAK-164 / Takeda
PK/PD data, Journal: Pharmacokinetics and Pharmacodynamics of TAK-164 Antibody Drug Conjugate Coadministered with Unconjugated Antibody. (Pubmed Central) - Oct 15, 2022
Rather, the cellular potency of DGN549 was matched with the single-cell uptake of TAK-164 making its IC close to its equilibrium binding affinity (K), and as such, coadministration dilutes total DGN549 in cells below the maximum cytotoxic concentration, thereby offsetting an increased number of targeted cells with decreased ability to kill each cell. These results provide new insights on matching payload potency to ADC delivery to help identify when increasing tumor penetration is beneficial for improving ADC efficacy and demonstrate how mechanistic simulations can be leveraged to design clinically effective ADCs.
- || TAK-164 / Takeda
PK/PD data, Journal: Quantifying ADC bystander payload penetration with cellular resolution using pharmacodynamic mapping. (Pubmed Central) - Oct 14, 2021
The penetration distance is similar to model predictions, where the lipophilicity results in moderate tissue penetration, thereby balancing improved tissue penetration with sufficient cellular uptake to avoid significant washout. These results aid in mechanistic understanding of the interplay between antigen heterogeneity, bystander effects, and heterogeneous delivery of ADCs in the tumor microenvironment to design clinically effective therapeutics.
- || TAK-164 / Takeda
PK/PD data, Journal: Pharmacokinetics and Catabolism of [H]TAK-164, a Guanylyl Cyclase C Targeted Antibody-Drug Conjugate. (Pubmed Central) - Sep 15, 2021
This study characterized in vitro and in vivo DNA binding mechanism and released products of TAK-164. The methodologies described here will be highly useful for characterization of payload-related products of ADCs in general.
- | indusatumab vedotin (TAK-264) / Takeda, TAK-164 / Takeda
Preclinical, Journal: Preclinical Antitumor Activity and Biodistribution of a Novel Anti-GCC Antibody-Drug Conjugate in Patient-Derived Xenografts. (Pubmed Central) - Aug 8, 2021
P1
A strong relationship between uptake of 89Zr-labeled TAK-164, levels of GCC expression and, most notably, response to TAK-164 therapy in GCC expressing xenografts and PHTX models. These data supported the clinical development of TAK-164 as part of a first-in-human clinical trial (NCT03449030).
- TAK-164 / Takeda
[VIRTUAL] A phase 1 study of TAK-164, an anti-guanylyl cyclase C (GCC) antibody-drug conjugate (ADC), in patients (pts) with advanced gastrointestinal (GI) cancers expressing GCC. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_859;
P1
TAK-164 appeared to have a manageable safety profile up to 0.064 mg/kg in pts with advanced GI cancers; hepatic toxicity was identified as a potential risk . The RP2D was determined as 0.064 mg/kg but was considered insufficient to derive significant clinical benefit.
- ||| TAK-164 / Takeda
Trial termination, Metastases: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (clinicaltrials.gov) - Mar 22, 2021
P1, N=31, Terminated, Sponsor: Millennium Pharmaceuticals, Inc.
The RP2D was determined as 0.064 mg/kg but was considered insufficient to derive significant clinical benefit. Completed --> Terminated; Insufficient clinical benefit to participants at the selected recommended phase 2 (RP2D) dose in Part A.
- TAK-164 / Takeda
Immune modulation following combination of TAK-164 with checkpoint inhibitors (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_641;
We performed immunophenotyping studies which revealed broad immunomodulation of lymphoid and myeloid cells by TAK-164 and combination regimens. Collectively these data support further interrogation of immune checkpoint inhibition in combination with TAK-164.
- || TAK-164 / Takeda
Trial completion, Trial completion date, Trial primary completion date, Metastases: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (clinicaltrials.gov) - Apr 22, 2020
P1, N=31, Completed, Sponsor: Millennium Pharmaceuticals, Inc.
Collectively these data support further interrogation of immune checkpoint inhibition in combination with TAK-164. Active, not recruiting --> Completed | Trial completion date: Oct 2021 --> Feb 2020 | Trial primary completion date: Oct 2021 --> Feb 2020
- || TAK-164 / Takeda
Enrollment closed, Enrollment change, Metastases: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (clinicaltrials.gov) - Feb 24, 2020
P1, N=31, Active, not recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Active, not recruiting --> Completed | Trial completion date: Oct 2021 --> Feb 2020 | Trial primary completion date: Oct 2021 --> Feb 2020 Recruiting --> Active, not recruiting | N=100 --> 31
- || TAK-164 / Takeda
Trial completion date, Trial primary completion date, Metastases: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (clinicaltrials.gov) - Nov 18, 2019
P1, N=100, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Recruiting --> Active, not recruiting | N=100 --> 31 Trial completion date: Apr 2021 --> Oct 2021 | Trial primary completion date: Apr 2021 --> Oct 2021
- | TAK-164 / Takeda
Trial completion date, Trial primary completion date, Metastases: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (clinicaltrials.gov) - Aug 28, 2019
P1, N=100, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
Trial completion date: Apr 2021 --> Oct 2021 | Trial primary completion date: Apr 2021 --> Oct 2021 Trial completion date: Apr 2022 --> Apr 2021 | Trial primary completion date: Apr 2022 --> Apr 2021
- | IMGN632 / Jazz, IMGN779 / Jazz, TAK-164 / Takeda
Journal: Synthesis of Highly Potent N-10 Amino-Linked DNA-Alkylating Indolinobenzodiazepine Antibody-Drug Conjugates (ADCs). (Pubmed Central) - Aug 16, 2019
Here, we present an alternative strategy for the IGNs, linking through a carbamate at the readily available N-10 amine present in the monoimine containing dimer. As a result, we have designed a series of N-10 linked IGN ADCs with a wide range of in vitro potency and tolerability, which may allow us to better match an IGN with a particular target based on the potential dosing needs.
- ||| TAK-164 / Takeda
Enrollment open, Metastases: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (clinicaltrials.gov) - May 1, 2018
P1, N=95, Recruiting, Sponsor: Millennium Pharmaceuticals, Inc.
As a result, we have designed a series of N-10 linked IGN ADCs with a wide range of in vitro potency and tolerability, which may allow us to better match an IGN with a particular target based on the potential dosing needs. Not yet recruiting --> Recruiting
- ||| TAK-164 / Takeda
New P1 trial, Metastases: A Study of TAK-164 in Participants With Advanced Gastrointestinal (GI) Cancer Expressing Guanylyl Cyclase C (GCC) (clinicaltrials.gov) - Feb 27, 2018
P1, N=95, Not yet recruiting, Sponsor: Millennium Pharmaceuticals, Inc.