Corbus Pharmaceuticals Announces that Clinical Data for CRB-701 from Western Dose Escalation Study to be Presented at ASCO GU 2025
Corbus Pharmaceuticals (NASDAQ: CRBP) announced that data from its first-in-human dose escalation clinical study of CRB-701 (SYS6002) will be presented at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco. The study, conducted in the US and UK, focuses on a next-generation Nectin-4 targeting antibody-drug conjugate.
The Phase 1 study (NCT06265727) consists of three parts and evaluates safety, pharmacokinetics, and efficacy in patients with advanced solid tumors showing high Nectin-4 expression. Part A of the study examined four predetermined doses: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg, and 4.5 mg/kg Q3W. The study will continue with Part B (dose optimization) and Part C (dose expansion) to determine recommended doses and assess preliminary efficacy.
Corbus Pharmaceuticals (NASDAQ: CRBP) ha annunciato che i dati del suo studio clinico di dose escalation di prima-in-umano riguardante CRB-701 (SYS6002) saranno presentati al Simposio sulle Neoplasie Genito-Urinarie ASCO 2025 a San Francisco. Lo studio, condotto negli Stati Uniti e nel Regno Unito, si concentra su un coniugato farmaco-anticorpo di nuova generazione mirato a Nectin-4.
Lo studio di Fase 1 (NCT06265727) è composto da tre parti e valuta la sicurezza, la farmacocinetica e l'efficacia nei pazienti con tumori solidi avanzati che mostrano un'elevata espressione di Nectin-4. La Parte A dello studio ha esaminato quattro dosi predeterminate: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg e 4.5 mg/kg ogni 3 settimane. Lo studio continuerà con la Parte B (ottimizzazione della dose) e la Parte C (espansione della dose) per determinare le dosi raccomandate e valutare l'efficacia preliminare.
Corbus Pharmaceuticals (NASDAQ: CRBP) anunció que los datos de su estudio clínico de escalado de dosis de primera aplicación en humanos sobre CRB-701 (SYS6002) se presentarán en el Simposio sobre Cánceres Genitourinarios de ASCO 2025 en San Francisco. El estudio, realizado en EE. UU. y Reino Unido, se centra en un conjugado de fármaco-anticuerpo de nueva generación dirigido a Nectin-4.
El estudio de Fase 1 (NCT06265727) consta de tres partes y evalúa la seguridad, la farmacocinética y la eficacia en pacientes con tumores sólidos avanzados que muestran una alta expresión de Nectin-4. La Parte A del estudio examinó cuatro dosis predeterminadas: 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg y 4.5 mg/kg cada 3 semanas. El estudio continuará con la Parte B (optimización de dosis) y la Parte C (expansión de dosis) para determinar las dosis recomendadas y evaluar la eficacia preliminar.
Corbus Pharmaceuticals (NASDAQ: CRBP)는 CRB-701 (SYS6002)의 첫 인간 투약 용량 증량 임상 연구 데이터를 2025 ASCO 생식기 암 심포지엄에서 샌프란시스코에서 발표할 것이라고 발표했습니다. 이 연구는 미국과 영국에서 진행되었고, Nectin-4를 타겟으로 하는 차세대 항체-약물 접합체에 초점을 맞추고 있습니다.
1상 연구(NCT06265727)는 세 부분으로 구성되어 있으며, Nectin-4의 높은 발현을 보이는 진행성 고형 종양 환자에서 안전성, 약리학적 동태 및 효능을 평가합니다. 연구의 A 부분은 1.8 mg/kg, 2.7 mg/kg, 3.6 mg/kg 및 4.5 mg/kg Q3W의 네 가지 미리 결정된 용량을 조사했습니다. 연구는 권장 용량을 결정하고 초기 효능을 평가하기 위해 B 부분(용량 최적화) 및 C 부분(용량 확장)으로 계속 진행될 예정입니다.
Corbus Pharmaceuticals (NASDAQ: CRBP) a annoncé que des données issues de son étude clinique de montée en dose de première utilisation chez l'homme pour CRB-701 (SYS6002) seront présentées au Symposium ASCO 2025 sur les cancers génito-urinaires à San Francisco. L'étude, conduite aux États-Unis et au Royaume-Uni, se concentre sur un conjugué anticorps-médicament de nouvelle génération ciblant Nectin-4.
L'étude de Phase 1 (NCT06265727) se compose de trois parties et évalue la sécurité, la pharmacocinétique et l'efficacité chez des patients atteints de tumeurs solides avancées présentant une forte expression de Nectin-4. La Partie A de l'étude a examiné quatre doses prédéterminées : 1,8 mg/kg, 2,7 mg/kg, 3,6 mg/kg et 4,5 mg/kg toutes les trois semaines. L'étude se poursuivra avec la Partie B (optimisation de la dose) et la Partie C (expansion de la dose) pour déterminer les doses recommandées et évaluer l'efficacité préliminaire.
Corbus Pharmaceuticals (NASDAQ: CRBP) gab bekannt, dass Daten aus seiner ersten klinischen Studie zur Dosissteigerung bei Menschen zu CRB-701 (SYS6002) auf dem 2025 ASCO Symposion über Genitourinale Krebserkrankungen in San Francisco präsentiert werden. Die Studie, die in den USA und im Vereinigten Königreich durchgeführt wird, konzentriert sich auf ein Antikörper-Wirkstoff-Konjugat der nächsten Generation, das auf Nectin-4 abzielt.
Die Phase-1-Studie (NCT06265727) besteht aus drei Teilen und bewertet die Sicherheit, Pharmakokinetik und Wirksamkeit bei Patienten mit fortgeschrittenen soliden Tumoren, die eine hohe Nectin-4-Expression zeigen. Teil A der Studie untersuchte vier vorgegebene Dosen: 1,8 mg/kg, 2,7 mg/kg, 3,6 mg/kg und 4,5 mg/kg alle drei Wochen. Die Studie wird mit Teil B (Dosisoptimierung) und Teil C (Dosisexpansion) fortgesetzt, um empfohlene Dosen zu bestimmen und die erste Wirksamkeit zu bewerten.
- Phase 1 clinical trial successfully completed dose escalation phase with four different dose levels
- Study data selected for presentation at major industry conference (ASCO GU 2025)
- None.
NORWOOD, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), today announced data from its first-in-human dose escalation clinical study conducted in the United States and the United Kingdom (“Western study”) of CRB-701 (SYS6002) will be presented at the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU), to be held in San Francisco, CA February 13–15, 2025.
The poster is titled 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 Tutors (Perez, et al) and will be presented on Friday February 14, 2025 [Poster Session B: Urothelial Carcinoma; Poster BD# G30].
The three-part Phase 1 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.
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
Sean.moran@corbuspharma.com
Bruce Mackle
Managing Director
LifeSci Advisors, LLC
bmackle@lifesciadvisors.com
FAQ
What are the dose levels being tested in the CRB-701 Phase 1 trial by CRBP?
When will CRBP present the CRB-701 clinical data at ASCO GU 2025?
What type of cancer patients are included in CRBP's CRB-701 clinical trial?
What are the three parts of CRBP's Phase 1 trial for CRB-701?
What is CRB-701's mechanism of action in CRBP's clinical trial?
