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1 Trial |  |
21 News |  |
- || ERY-974 / Roche
Trial completion date, Trial primary completion date, Metastases: A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - Feb 15, 2024
P1, N=179, Recruiting, Sponsor: Chugai Pharmaceutical
Trial completion date: Sep 2024 --> Dec 2025 | Trial primary completion date: Sep 2024 --> Dec 2025
- | ERY-974 / Roche
Journal: Combination of T cell-redirecting bispecific antibody ERY974 and chemotherapy reciprocally enhances efficacy against non-inflamed tumours. (Pubmed Central) - Sep 16, 2022
ERY974 increases capecitabine-induced cytotoxicity by promoting capecitabine conversion to its active form by inducing thymidine phosphorylase expression in non-inflamed MKN45 tumour through ERY974-induced IFNγ and TNFα in T cells. We show that ERY974 with chemotherapy synergistically and reciprocally increases antitumour efficacy, eradicating non-inflamed tumours.
- || ERY-974 / Roche
P1 data, Journal: Determination of starting dose of the T cell-redirecting bispecific antibody ERY974 targeting glypican-3 in first-in-human clinical trial. (Pubmed Central) - Jul 23, 2022
P1
For the phase I clinical trial, we selected 3.0 ng/kg as a starting dose, which was lower than the first-in-human dose calculated from both the no observed adverse effect level and minimal anticipated biological effect level. Combining these two methods to determine the first-in-human dose of strong immune modulators such as T cell-redirecting antibodies would be a suitable approach from safety and efficacy perspectives.Clinical trial registration: JapicCTI-194805/NCT05022927.
- | ERY-974 / Roche
Preclinical, Journal, IO biomarker: Priming treatment with T-cell redirecting bispecific antibody ERY974 reduced cytokine induction without losing cytotoxic activity in vitro by changing the chromatin state in T cells. (Pubmed Central) - Apr 30, 2022
CD3ɛ expression, CD3-mediated signal transduction, T cell activation markers, and cytotoxicity were similar between the priming treatment with ERY974 and negative control. The present study suggests that chromatin state changes in T cells after the priming treatment was a pivotal factor in the mitigation of cytokine release after the second ERY974 treatment.
- ||| ERY-974 / Roche
New P1 trial, Combination therapy, IO biomarker, Metastases: A Phase I Study of ERY974 in Patients With Hepatocellular Carcinoma (clinicaltrials.gov) - Aug 25, 2021
P1, N=158, Recruiting, Sponsor: Chugai Pharmaceutical
- | ERY-974 / Roche
Preclinical, Journal, IO biomarker: Preclinical PET imaging of bispecific antibody ERY974 targeting CD3 and glypican 3 reveals that tumor uptake correlates to T cell infiltrate. (Pubmed Central) - Jun 9, 2021
The present study suggests that chromatin state changes in T cells after the priming treatment was a pivotal factor in the mitigation of cytokine release after the second ERY974 treatment. Zr-N-suc-Df-ERY974 can potentially be used to study ERY974 biodistribution in patients to support drug development.
- ERY-974 / Roche
[VIRTUAL] ERY974, an Anti-Glypican 3/CD3 Bispecific T Cell-Redirecting Antibody for Treatment of Solid Tumors () - Apr 4, 2021 - Abstract #PEGS2021PEGS_120;
ERY974 exerts strong anti-tumor activity against a variety of tumor models including those with a non-inflamed phenotype. In this talk, I will discuss the detailed preclinical characterization of ERY974, including the cytokine release mechanism and potential combination therapies.
- ERY-974 / Roche
[VIRTUAL] Results of a phase 1 dose escalation study of ERY974, an anti-glypican 3 (GPC3)/CD3 bispecific antibody, in patients with advanced solid tumors. () - Mar 11, 2021 - Abstract #AACR2021AACR_2555;
At doses below 0.81 μg/kg (regimen A), ERY974 was generally well tolerated with a manageable toxicity profile, including ERY-induced CRS which was manageable with steroid administration and anti-IL6R therapy. Further research is required to determine if combined prophylactic anti-IL6R and steroid therapy is a more effective strategy for managing CRS.
- | ERY-974 / Roche
Preclinical, Journal: In vitro toxicological support to establish specification limit for anti-CD3 monospecific impurity in a bispecific T cell engager drug, ERY974. (Pubmed Central) - Mar 11, 2021
This suggests that specification limit should be decided for each type of anti-CD3 impurity that affects T cell-activating BiAb drug products. In vitro cytokine assays can provide useful information for determining these specification limits.
- | ERY-974 / Roche
Journal: Daily ascending dosing in cynomolgus monkeys to mitigate cytokine release syndrome induced by ERY22, surrogate for T-cell redirecting bispecific antibody ERY974 for cancer immunotherapy. (Pubmed Central) - Jun 4, 2020
Peak cytokine levels following the single and ascending doses were 60,095 pg/mL and 1221 pg/mL for IL-6; 353 pg/mL and 14 pg/mL for TNF-α; 123 pg/mL and 16 pg/mL for IFN-γ; and 2219 pg/mL and 42 pg/mL for IL-2. The tolerance acquired with daily ascending doses up to 1000 μg/kg remained in effect for the following weekly doses of 1000 μg/kg.
- | ERY-974 / Roche
Journal: Engineering a bispecific antibody with a common light chain: Identification and optimization of an anti-CD3 epsilon and anti-GPC3 bispecific antibody, ERY974. (Pubmed Central) - Nov 30, 2019
This format includes one of Chugai's proprietary technologies, termed ART-Ig technology, which consists of a method to identify a common light chain, isoelectric point (pI) engineering to purify the desired bispecific IgG antibody from byproducts, and Fc heterodimerization by an electrostatic steering effect. Furthermore, we describe some tips for de-risking the antibody when engineering a T cell redirecting antibody.
- | ERY-974 / Roche
Trial completion, Trial completion date, Trial primary completion date, Metastases: A Study of ERY974 in Patient With Advanced Solid Tumors (clinicaltrials.gov) - Aug 22, 2019
P1, N=29, Completed, Sponsor: Chugai Pharmaceutical
Furthermore, we describe some tips for de-risking the antibody when engineering a T cell redirecting antibody. Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Aug 2019 | Trial primary completion date: Dec 2019 --> Aug 2019
- || ERY-974 / Roche
Enrollment closed, Enrollment change, Metastases: A Study of ERY974 in Patient With Advanced Solid Tumors (clinicaltrials.gov) - Feb 6, 2019
P1, N=29, Active, not recruiting, Sponsor: Chugai Pharmaceutical
Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Aug 2019 | Trial primary completion date: Dec 2019 --> Aug 2019 Suspended --> Active, not recruiting | N=125 --> 29
- | ERY-974 / Roche
Trial suspension, Metastases: A Study of ERY974 in Patient With Advanced Solid Tumors (clinicaltrials.gov) - Sep 5, 2018
P1, N=125, Suspended, Sponsor: Chugai Pharmaceutical
Suspended --> Active, not recruiting | N=125 --> 29 Recruiting --> Suspended
- ||| ERY-974 / Roche
Enrollment open, Metastases: A Study of ERY974 in Patient With Advanced Solid Tumors (clinicaltrials.gov) - Sep 21, 2016
P1, N=125, Recruiting, Sponsor: Chugai Pharmaceutical
Recruiting --> Suspended Not yet recruiting --> Recruiting
- ||| ERY-974 / Roche
New P1 trial, Metastases: A Study of ERY974 in Patient With Advanced Solid Tumors (clinicaltrials.gov) - Apr 22, 2016
P1, N=125, Not yet recruiting, Sponsor: Chugai Pharmaceutical