Corbus Pharmaceuticals Announces Clinical Data for CRB-701 from Western Dose Escalation Study to be Presented at 2025 ASCO-GU
Corbus Pharmaceuticals (NASDAQ: CRBP) announced the release of abstract data from their first-in-human dose escalation clinical study of CRB-701 (SYS6002), which will be presented at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco. The Western study, conducted in the US and Europe, includes updated data from 38 patients as of December 2024, expanding from the 31 patients covered in the September 2024 abstract.
The three-part Phase 1 study (NCT06265727) evaluates CRB-701's safety, pharmacokinetics, and efficacy in patients with advanced solid tumors showing high Nectin-4 expression. Part A evaluated four predetermined doses (1.8, 2.7, 3.6, and 4.5 mg/kg Q3W), followed by Parts B and C focusing on dose optimization and expansion to determine recommended doses and preliminary efficacy signals.
Corbus Pharmaceuticals (NASDAQ: CRBP) ha annunciato il rilascio dei dati di un abstract del loro primo studio clinico di escalation della dose su esseri umani riguardante CRB-701 (SYS6002), che sarà presentato al Simposio sulle Cancers Genitourinarie ASCO 2025 a San Francisco. Lo studio occidentale, condotto negli Stati Uniti e in Europa, include dati aggiornati su 38 pazienti a partire da dicembre 2024, ampliando il numero rispetto ai 31 pazienti riportati nell'abstract di settembre 2024.
Lo studio di fase 1 (NCT06265727) è suddiviso in tre parti e valuta la sicurezza, la farmacocinetica e l'efficacia di CRB-701 in pazienti con tumori solidi avanzati che mostrano un'alta espressione di Nectin-4. La Parte A ha valutato quattro dosi predefinite (1,8, 2,7, 3,6 e 4,5 mg/kg Q3W), seguita dalle Parti B e C che si concentrano sull'ottimizzazione della dose e sull'espansione per determinare le dosi raccomandate e i segnali di efficacia preliminare.
Corbus Pharmaceuticals (NASDAQ: CRBP) anunció la publicación de datos abstractos de su primer estudio clínico de escalada de dosis en humanos de CRB-701 (SYS6002), que se presentará en el Simposio sobre Cánceres Genitourinarios ASCO 2025 en San Francisco. El estudio occidental, realizado en los EE. UU. y Europa, incluye datos actualizados de 38 pacientes hasta diciembre de 2024, ampliando el número desde los 31 pacientes incluidos en el abstract de septiembre de 2024.
El estudio de Fase 1 (NCT06265727) consta de tres partes y evalúa la seguridad, la farmacocinética y la eficacia de CRB-701 en pacientes con tumores sólidos avanzados que presentan una alta expresión de Nectin-4. La Parte A evaluó cuatro dosis predeterminadas (1.8, 2.7, 3.6 y 4.5 mg/kg Q3W), seguida de las Partes B y C que se centran en la optimización de dosis y expansión para determinar las dosis recomendadas y señales preliminares de eficacia.
코르부스 제약 (NASDAQ: CRBP)는 CRB-701 (SYS6002)에 대한 첫 번째 인체 용량 증량 임상 연구의 초록 데이터를 발표했다고 발표했습니다. 이 연구는 2025년 샌프란시스코에서 열리는 ASCO 비뇨기암 심포지엄에서 발표될 예정입니다. 미국과 유럽에서 실시된 이 서부 연구는 2024년 12월 기준으로 38명의 환자에 대한 업데이트된 데이터를 포함하며, 2024년 9월 초록에 포함된 31명에서 증가하였습니다.
세 부분으로 나누어진 1상 연구 (NCT06265727)는 Nectin-4의 높은 발현을 보이는 고급 고형 종양 환자에서 CRB-701의 안전성, 약동학 및 유효성을 평가합니다. A 부분에서는 4개의 미리 정해진 용량(1.8, 2.7, 3.6 및 4.5 mg/kg Q3W)을 평가하였으며, 이어서 B 및 C 부분이 추천 용량과 초기 유효성 신호를 결정하기 위한 용량 최적화 및 확장에 중점을 두었습니다.
Corbus Pharmaceuticals (NASDAQ: CRBP) a annoncé la publication de données d'abstract de sa première étude clinique d'escalade de dose chez l'homme portant sur CRB-701 (SYS6002), qui sera présentée lors du Symposium sur les cancers génito-urinaires de l'ASCO 2025 à San Francisco. L'étude occidentale, réalisée aux États-Unis et en Europe, comprend des données mises à jour portant sur 38 patients à partir de décembre 2024, élargissant le nombre par rapport aux 31 patients couverts dans l'abstract de septembre 2024.
La phase 1 de l'étude (NCT06265727) se divise en trois parties et évalue la sécurité, la pharmacocinétique et l'efficacité de CRB-701 chez des patients atteints de tumeurs solides avancées montrant une forte expression de Nectin-4. La Partie A a évalué quatre doses prédéterminées (1,8, 2,7, 3,6 et 4,5 mg/kg Q3W), suivies des Parties B et C qui se concentrent sur l'optimisation de la dose et l'expansion pour déterminer les doses recommandées et les signaux d'efficacité préliminaire.
Corbus Pharmaceuticals (NASDAQ: CRBP) gab die Veröffentlichung von Abstract-Daten aus ihrer ersten klinischen Studie zur Dosiseskalation beim Menschen zu CRB-701 (SYS6002) bekannt, die auf dem ASCO-Symposium für genitouräre Krebserkrankungen 2025 in San Francisco präsentiert wird. Die westliche Studie, die in den USA und Europa durchgeführt wurde, umfasst aktualisierte Daten von 38 Patienten bis Dezember 2024, was eine Erweiterung von den 31 Patienten darstellt, die im Abstract vom September 2024 erfasst wurden.
Die dreiteilige Phase 1-Studie (NCT06265727) bewertet die Sicherheit, Pharmakokinetik und Wirksamkeit von CRB-701 bei Patienten mit fortgeschrittenen soliden Tumoren mit hoher Nectin-4-Expression. Teil A bewertete vier festgelegte Dosen (1,8, 2,7, 3,6 und 4,5 mg/kg Q3W), gefolgt von den Teilen B und C, die sich auf die Dosisoptimierung und -erweiterung konzentrieren, um empfohlene Dosen und vorläufige Wirksamkeitssignale zu bestimmen.
- Phase 1 study progression with successful completion of Part A dose escalation
- Expanded patient enrollment from 31 to 38 patients
- Study selected for presentation at major medical conference (ASCO-GU)
- None.
NORWOOD, Mass., Feb. 11, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced that the abstract for its first-in-human dose escalation clinical study conducted in the United States and Europe (“Western study”) of CRB-701 (SYS6002) has been released. The corresponding up-to-date data will be presented as a poster during the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU). The data from 31 patients referred to in the abstract dates to September 2024; the upcoming poster presentation will include data on 38 patients as of December 2024. ASCO GU will be held in San Francisco, CA February 13-15, 2025.
The abstract, Phase 1 Dose-Escalation Study of Next-Generation Nectin-4 Targeting Antibody-Drug Conjugate CRB-701 (SYS6002) in US And UK Patients with Urothelial Cancer and other Solid Tumors (Perez, et al) will be presented on Friday February 14, 2025 [Poster Session B: Urothelial Carcinoma; 11:30-12:45PM PST, Level 1 West Hall, Poster BD# G3].
The three-part Phase 1 Western study (NCT06265727) is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in patients with advanced solid tumors associated with high Nectin-4 expression. The Part A dose escalation of the study evaluated four predetermined doses (1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg and 4.5 mg/kg Q3W) and is followed by Part B (dose optimization) and Part C (dose expansion) that will determine recommended/optimized doses and seek preliminary efficacy signals.
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting Nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer.
About Corbus
Corbus Pharmaceuticals Holdings, Inc. is an oncology and obesity company with a diversified portfolio and is committed to helping people defeat serious illness by bringing innovative scientific approaches to well-understood biological pathways. Corbus’ pipeline includes CRB-701, a next generation antibody drug conjugate that targets the expression of Nectin-4 on cancer cells to release a cytotoxic payload, CRB-601, an anti-integrin monoclonal antibody which blocks the activation of TGFβ expressed on cancer cells, and CRB-913, a highly peripherally restricted CB1 receptor inverse agonist for the treatment of obesity. Corbus is headquartered in Norwood, Massachusetts. For more information on Corbus, visit corbuspharma.com. Connect with us on X, LinkedIn and Facebook.
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INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
Sean.moran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
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