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- || MEDI4276 / AstraZeneca
Clinical, P1 data, Journal: First-in-Human, Phase 1 Dose-Escalation Study of Biparatopic Anti-HER2 Antibody-Drug Conjugate MEDI4276 in Patients with HER2+ Advanced Breast or Gastric Cancer. (Pubmed Central) - Feb 19, 2022
In the as-treated population, there was 1 complete response (0.5 mg/kg; BC), and 2 partial responses (0.6 and 0.75 mg/kg; BC)-all had prior trastuzumab, pertuzumab, and ado-trastuzumab emtansine (T-DM1). MEDI4276 has demonstrable clinical activity but displays intolerable toxicity at doses >0.3 mg/kg.
- | MEDI4276 / AstraZeneca
Clinical, Journal: Multiplex LC-MS/MS Assays for Clinical Bioanalysis of MEDI4276, an Antibody-Drug Conjugate of Tubulysin Analogue Attached via Cleavable Linker to a Biparatopic Humanized Antibody against HER-2. (Pubmed Central) - Sep 25, 2019
P1/2
Additional stability experiments confirmed that quantification of the released warhead in the presence of high concentrations of MEDI4276 was acceptable. Subsequently, the assays were employed in support of a first-in-human clinical trial (NCT02576548).
- | Review, Journal: HER2 Directed Antibody-Drug-Conjugates beyond T-DM1 in Breast Cancer. (Pubmed Central) - Jun 15, 2019
Currently, several HER2 directed antibody-drug conjugates are under clinical investigation for HER2 amplified but also HER2 expressing but not amplified breast tumors. In this article, we review the current preclinical and clinical evidence of the investigational drugs A166, ALT-P7, ARX788, DHES0815A, DS-8201a, RC48, SYD985, MEDI4276 and XMT-1522.
- || MEDI4276 / AstraZeneca
Trial completion, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - Jun 25, 2018
P1/2, N=47, Completed, Sponsor: MedImmune LLC
In this article, we review the current preclinical and clinical evidence of the investigational drugs A166, ALT-P7, ARX788, DHES0815A, DS-8201a, RC48, SYD985, MEDI4276 and XMT-1522. Active, not recruiting --> Completed
- MEDI4276 / AstraZeneca
Trial completion date, Trial primary completion date, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - Apr 25, 2018
P1/2, N=47, Active, not recruiting, Sponsor: MedImmune LLC
Active, not recruiting --> Completed Trial completion date: Oct 2019 --> Jul 2018 | Trial primary completion date: Oct 2019 --> Jul 2018
- | MEDI4276 / AstraZeneca
Enrollment closed, Enrollment change, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - Jan 24, 2018
P1/2, N=47, Active, not recruiting, Sponsor: MedImmune LLC
Trial completion date: Oct 2019 --> Jul 2018 | Trial primary completion date: Oct 2019 --> Jul 2018 Recruiting --> Active, not recruiting | N=216 --> 47
- | MEDI4276 / AstraZeneca
Phase classification, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - Dec 1, 2016
P1/2, N=216, Recruiting, Sponsor: MedImmune LLC
Recruiting --> Active, not recruiting | N=216 --> 47 Phase classification: P1 --> P1/2
- || MEDI4276 / AstraZeneca
Enrollment change, Trial primary completion date, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - Aug 26, 2016
P1, N=216, Recruiting, Sponsor: MedImmune LLC
Phase classification: P1 --> P1/2 N=159 --> 216 | Trial primary completion date: Jan 2019 --> Oct 2019
- || MEDI4276 / AstraZeneca
Enrollment change, Trial primary completion date, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - May 11, 2016
P1, N=159, Recruiting, Sponsor: MedImmune LLC
N=159 --> 216 | Trial primary completion date: Jan 2019 --> Oct 2019 N=120 --> 159 | Trial primary completion date: Sep 2018 --> Jan 2019
- || MEDI4276 / AstraZeneca
Trial primary completion date, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - Feb 17, 2016
P1, N=120, Recruiting, Sponsor: MedImmune LLC
N=120 --> 159 | Trial primary completion date: Sep 2018 --> Jan 2019 Trial primary completion date: Jun 2017 --> Sep 2018
- ||| MEDI4276 / AstraZeneca
New P1 trial, Metastases: D5760C00001: A Phase 1/2 Study of MEDI4276 in Adults Subjects With Select HER2-expressing Advanced Solid Tumors. (clinicaltrials.gov) - Oct 22, 2015
P1, N=120, Recruiting, Sponsor: MedImmune LLC