Corbus Pharmaceuticals Announces First Patient Dosed with its Nectin-4 Targeting ADC CRB-701 in Combination with Pembrolizumab
Corbus Pharmaceuticals (NASDAQ: CRBP) has initiated the PD-1 combination arm of its Phase 1 study for CRB-701, dosing its first participant. The combination therapy involves CRB-701 with Keytruda® (pembrolizumab) at doses of 2.7 mg/kg and 3.6 mg/kg.
The three-part Phase 1 study (NCT06265727) focuses on advanced solid tumors with high Nectin-4 expression, with over 100 participants dosed in the monotherapy cohort. The study prioritizes Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer. The company plans to provide a data update and establish the recommended Phase 2 dose in Q4 2025.
Corbus Pharmaceuticals (NASDAQ: CRBP) ha avviato il braccio di combinazione PD-1 del suo studio di Fase 1 per CRB-701, somministrando la prima dose a un partecipante. La terapia combinata prevede CRB-701 insieme a Keytruda® (pembrolizumab) a dosi di 2,7 mg/kg e 3,6 mg/kg.
Lo studio di Fase 1, suddiviso in tre parti (NCT06265727), si concentra su tumori solidi avanzati con alta espressione di Nectin-4, con oltre 100 partecipanti già trattati nel gruppo di monoterapia. Lo studio dà priorità a carcinoma squamoso della testa e del collo (HNSCC) e al cancro cervicale. L’azienda prevede di fornire un aggiornamento sui dati e di stabilire la dose raccomandata per la Fase 2 nel quarto trimestre 2025.
Corbus Pharmaceuticals (NASDAQ: CRBP) ha iniciado el brazo de combinación PD-1 de su estudio de Fase 1 para CRB-701, administrando la primera dosis a un participante. La terapia combinada incluye CRB-701 junto con Keytruda® (pembrolizumab) en dosis de 2,7 mg/kg y 3,6 mg/kg.
El estudio de Fase 1, dividido en tres partes (NCT06265727), se centra en tumores sólidos avanzados con alta expresión de Nectin-4, con más de 100 participantes tratados en la cohorte de monoterapia. El estudio prioriza el carcinoma de células escamosas de cabeza y cuello (HNSCC) y el cáncer cervical. La compañía planea proporcionar una actualización de datos y establecer la dosis recomendada para la Fase 2 en el cuarto trimestre de 2025.
Corbus Pharmaceuticals (NASDAQ: CRBP)가 CRB-701의 1상 연구 중 PD-1 병용 치료군을 시작하여 첫 참가자에게 투여를 시작했습니다. 병용 요법은 CRB-701과 Keytruda® (펨브롤리주맙)를 각각 2.7 mg/kg 및 3.6 mg/kg 용량으로 투여하는 방식입니다.
3단계로 구성된 1상 연구(NCT06265727)는 Nectin-4 발현이 높은 진행성 고형 종양에 초점을 맞추고 있으며, 단독 요법 코호트에서는 100명 이상의 참가자가 투여를 받았습니다. 연구는 두경부 편평세포암(HNSCC)과 자궁경부암에 우선순위를 두고 있습니다. 회사는 2025년 4분기에 데이터 업데이트와 2상 권장 용량 확정을 계획하고 있습니다.
Corbus Pharmaceuticals (NASDAQ : CRBP) a lancé le bras de combinaison PD-1 de son étude de Phase 1 pour CRB-701, en administrant la première dose à un participant. La thérapie combinée associe CRB-701 à Keytruda® (pembrolizumab) à des doses de 2,7 mg/kg et 3,6 mg/kg.
Cette étude de Phase 1 en trois parties (NCT06265727) cible les tumeurs solides avancées avec une forte expression de Nectin-4, avec plus de 100 participants traités dans la cohorte monothérapie. L'étude accorde la priorité au carcinome épidermoïde de la tête et du cou (HNSCC) et au cancer du col de l'utérus. La société prévoit de fournir une mise à jour des données et de définir la dose recommandée pour la Phase 2 au 4e trimestre 2025.
Corbus Pharmaceuticals (NASDAQ: CRBP) hat den PD-1-Kombinationsarm seiner Phase-1-Studie für CRB-701 gestartet und den ersten Teilnehmer dosiert. Die Kombinationstherapie umfasst CRB-701 zusammen mit Keytruda® (Pembrolizumab) in Dosierungen von 2,7 mg/kg und 3,6 mg/kg.
Die dreiteilige Phase-1-Studie (NCT06265727) konzentriert sich auf fortgeschrittene solide Tumoren mit hoher Nectin-4-Expression, wobei über 100 Teilnehmer in der Monotherapie-Kohorte behandelt wurden. Die Studie priorisiert Plattenepithelkarzinom des Kopf- und Halsbereichs (HNSCC) und Gebärmutterhalskrebs. Das Unternehmen plant, im 4. Quartal 2025 ein Datenupdate zu liefern und die empfohlene Phase-2-Dosis festzulegen.
- Over 100 participants successfully dosed in monotherapy cohort
- CRB-701 shows differentiated safety, tolerability and efficacy profiles in HNSCC, cervical and mUC tumors
- Study progressing well with encouraging enrollment rate
- None.
- Combination cohort initiated following successful review of monotherapy cohort
- Over 100 participants dosed to-date in monotherapy cohort
- Priority are Head and Neck Squamous Cell Carcinoma (HNSCC) and cervical cancer
- Data update on schedule for later this year
NORWOOD, Mass., June 25, 2025 (GLOBE NEWSWIRE) -- Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical-stage company focused on oncology and obesity, today announced the dosing of the first participant in the PD-1 combination arm of its Phase 1 study investigating CRB-701 in solid tumors (the Phase 1 Western study). Participants in this arm of the study are being randomized to the 2.7 mg/kg and 3.6 mg/kg cohorts in combination with Keytruda® (pembrolizumab).
“We are very pleased to reach this important milestone and with such an encouraging rate of enrollment in our CRB-701 program,” said Dr. Dominic Smethurst, MA MRCP, Chief Medical Officer of Corbus. “CRB-701 data demonstrates differentiated safety, tolerability and efficacy profiles in HNSCC, cervical and mUC tumors.”
The three-part Phase 1 study (NCT06265727) is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in participants 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). The Company expects to provide a data update and establish the recommended Phase 2 dose (RP2D) in the fourth quarter of this year.
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 a clinical-stage company focused on oncology and obesity 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 that 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, including timing for completion of trials and presentation of data, 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.
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INVESTOR CONTACT:
Sean Moran
Chief Financial Officer
Corbus Pharmaceuticals
smoran@corbuspharma.com
Dan Ferry
Managing Director
LifeSci Advisors, LLC
daniel@lifesciadvisors.com
FAQ
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