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- | serclutamab talirine (ABBV-321) / AbbVie, depatuxizumab mafodotin (ABT-414) / AbbVie
Journal: Convection enhanced delivery of EGFR targeting antibody-drug conjugates Serclutamab talirine and Depatux-M in glioblastoma patient-derived xenografts. (Pubmed Central) - Sep 11, 2022
CED of Depatux-M is well tolerated and results in extended survival in orthotopic GBM PDXs. In contrast, CED of Ser-T was associated with a much narrower therapeutic window.
- serclutamab talirine (ABBV-321) / AbbVie, depatuxizumab mafodotin (ABT-414) / AbbVie
Convection enhanced delivery of EGFR-targeting antibody drug conjugates ABBV-321 and Depatux-M (Section 22) - Mar 9, 2022 - Abstract #AACR2022AACR_2719;
Depatux-M is well tolerated when infused into normal brain and results in extended survival in orthotopic GBM PDXs. In contrast, ABBV-321, with a distinct PBD toxin, had a much narrower therapeutic window when delivered by CED.
- serclutamab talirine (ABBV-321) / AbbVie
[VIRTUAL] A Phase I Efficacy & Safety Study of Serclutamab Talirine, an EGFR Targeting Antibody Drug Conjugate, in Subjects with Recurrent Glioblastoma (GBM) () - Sep 23, 2021 - Abstract #ADCUSA2021ADC_USA_143;
In contrast, ABBV-321, with a distinct PBD toxin, had a much narrower therapeutic window when delivered by CED. Review of targeting EGFR with antibody drug conjugates in solid tumors Examine the efficacy and safety of Serclutamab Talirine in subjects with recurrent glioblastoma Discuss conclusions and future directions
- | serclutamab talirine (ABBV-321) / AbbVie, depatuxizumab mafodotin (ABT-414) / AbbVie, losatuxizumab vedotin (ABBV-221) / AbbVie
Journal: Targeting Multiple EGFR Expressing Tumors with a Highly Potent Tumor-Selective Antibody Drug Conjugate. (Pubmed Central) - Aug 8, 2021
Collectively, these data suggest that ABBV-321 may offer an extended breadth of efficacy relative to other EGFR ADCs while extending utility to multiple EGFR-expressing tumor indications. Despite its highly potent PBD dimer payload, the tumor selectivity of ABBV-321 - coupled with its pharmacology, toxicology and pharmacokinetic profiles - support continuation of ongoing Phase 1 clinical trials in patients with advanced EGFR-expressing malignancies.
- | navitoclax (ABT 263) / AbbVie, Roche
Journal, IO biomarker: Navitoclax enhances the effectiveness of EGFR-targeted antibody-drug conjugates in PDX models of EGFR-expressing triple-negative breast cancer. (Pubmed Central) - Jun 22, 2021
Despite its highly potent PBD dimer payload, the tumor selectivity of ABBV-321 - coupled with its pharmacology, toxicology and pharmacokinetic profiles - support continuation of ongoing Phase 1 clinical trials in patients with advanced EGFR-expressing malignancies. The dramatic tumor regressions achieved using combined agents in pre-clinical TNBC models underscore the abilities of BCL-2/X antagonists to enhance the effectiveness of EGFR-targeted ADCs and highlight the clinical potential for usage of such targeted ADCs to alleviate toxicities associated with combinations of BCL-2/X inhibitors and systemic chemotherapies.
- ||| serclutamab talirine (ABBV-321) / AbbVie
Trial completion, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - May 6, 2021
P1, N=62, Completed, Sponsor: AbbVie
The dramatic tumor regressions achieved using combined agents in pre-clinical TNBC models underscore the abilities of BCL-2/X antagonists to enhance the effectiveness of EGFR-targeted ADCs and highlight the clinical potential for usage of such targeted ADCs to alleviate toxicities associated with combinations of BCL-2/X inhibitors and systemic chemotherapies. Active, not recruiting --> Completed
- Avastin (bevacizumab) / Roche
[VIRTUAL] An investigation into the impact of next generation sequencing on the use of targeted treatments in glioblastoma. () - Apr 28, 2021 - Abstract #ASCO2021ASCO_1965;
Although this study is limited by being a single institution study, future efforts include expanding this analysis to multiple institutions . With improvements in therapeutics as well as with wider availability of NGS testing, sequencing data may impact a larger percentage of glioblastoma patients.
- || serclutamab talirine (ABBV-321) / AbbVie
Enrollment closed, Enrollment change, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Feb 12, 2021
P1, N=62, Active, not recruiting, Sponsor: AbbVie
With improvements in therapeutics as well as with wider availability of NGS testing, sequencing data may impact a larger percentage of glioblastoma patients. Recruiting --> Active, not recruiting | N=120 --> 62
- || serclutamab talirine (ABBV-321) / AbbVie
Trial completion date, Trial primary completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Aug 11, 2020
P1, N=120, Recruiting, Sponsor: AbbVie
Recruiting --> Active, not recruiting | N=120 --> 62 Trial completion date: Jan 2023 --> May 2021 | Trial primary completion date: Jan 2023 --> May 2021
- || serclutamab talirine (ABBV-321) / AbbVie
Trial completion date, Trial primary completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Jun 9, 2020
P1, N=120, Recruiting, Sponsor: AbbVie
Trial completion date: Jan 2023 --> May 2021 | Trial primary completion date: Jan 2023 --> May 2021 Trial completion date: Sep 2025 --> Jan 2023 | Trial primary completion date: Mar 2024 --> Jan 2023
- ABBV-321 / AbbVie
[VIRTUAL] Phase I study of the antibody-drug conjugate ABBV-321 in patients with non-small cell lung cancer and squamous head and neck cancer with overexpression of the epidermal growth factor receptor. (Poster Board 379) - Apr 29, 2020 - Abstract #ASCO2020ASCO_1596;
P1
The dose-escalation phase has been completed; screening and enrollment for the expansion phase of the study in NSCLC and HNSCC is underway. Research Funding: AbbVie, Inc.
- Pre-clinical assessment of combined ABT-263/Navitoclax and ABT-414 or ABBV-321 treatment for EGFR-expressingTNBC (Hall 1 - Poster Session 3) - Sep 25, 2019 - Abstract #SABCS2019SABCS_1374;
Notably, this strategy avoids the toxicities associated with systemic chemotherapy and BCL-2/XL-inhibitors. These results also highlight the translational relevance of 321+263, within the context of EGFR-expressing TNBC.
- | serclutamab talirine (ABBV-321) / AbbVie
Trial completion date, Trial primary completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Sep 9, 2019
P1, N=120, Recruiting, Sponsor: AbbVie
These results also highlight the translational relevance of 321+263, within the context of EGFR-expressing TNBC. Trial completion date: Aug 2023 --> Sep 2025 | Trial primary completion date: Aug 2021 --> Mar 2024
- || serclutamab talirine (ABBV-321) / AbbVie
Trial primary completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - May 3, 2019
P1, N=120, Recruiting, Sponsor: AbbVie
Trial completion date: Aug 2023 --> Sep 2025 | Trial primary completion date: Aug 2021 --> Mar 2024 Trial primary completion date: Sep 2019 --> Aug 2021
- || serclutamab talirine (ABBV-321) / AbbVie
Trial primary completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Dec 19, 2018
P1, N=120, Recruiting, Sponsor: AbbVie
Trial primary completion date: Sep 2019 --> Aug 2021 Trial primary completion date: Mar 2019 --> Sep 2019
- || serclutamab talirine (ABBV-321) / AbbVie
Trial completion date, Trial primary completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Aug 1, 2018
P1, N=120, Recruiting, Sponsor: AbbVie
Trial primary completion date: Mar 2019 --> Sep 2019 Trial completion date: Oct 2022 --> Jun 2023 | Trial primary completion date: Sep 2019 --> Mar 2019
- || serclutamab talirine (ABBV-321) / AbbVie
Enrollment change, Trial primary completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Apr 27, 2018
P1, N=120, Recruiting, Sponsor: AbbVie
Trial completion date: Oct 2022 --> Jun 2023 | Trial primary completion date: Sep 2019 --> Mar 2019 N=80 --> 120 | Trial primary completion date: Mar 2019 --> Sep 2019
- | serclutamab talirine (ABBV-321) / AbbVie
Trial completion date, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Mar 3, 2018
P1, N=80, Recruiting, Sponsor: AbbVie
N=80 --> 120 | Trial primary completion date: Mar 2019 --> Sep 2019 Trial completion date: Mar 2024 --> Oct 2022
- ||| serclutamab talirine (ABBV-321) / AbbVie
Enrollment open, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Nov 13, 2017
P1, N=80, Recruiting, Sponsor: AbbVie
Trial completion date: Mar 2024 --> Oct 2022 Not yet recruiting --> Recruiting
- ||| serclutamab talirine (ABBV-321) / AbbVie
New P1 trial, Metastases: A Study Evaluating the Safety, Pharmacokinetics, and Anti-tumor Activity of ABBV-321 in Subjects With Advanced Solid Tumors Associated With Overexpression of the Epidermal Growth Factor Receptor (EGFR) (clinicaltrials.gov) - Jul 30, 2017
P1, N=80, Not yet recruiting, Sponsor: AbbVie