Drugs / CRB-701
last change 4 days ago re-read 3 minutes ago

CRB-701

Other / unclassified

Developed for
cancer
Investigated by
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd. · Corbus Pharmaceuticals Inc.

Trials 1

202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT06265727 Apr 2024 → Jan 2027 expected cancer Corbus Pharmaceuticals Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 12

DateIssuerRelease
2026-07-29 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Regulatory VOLUNTARY ANNOUNCEMENT - CRB-701 (SYS6002) RECEIVES U.S. FDA CLEARANCE FOR THE REGISTRATIONAL TRIAL FOR THE SECOND-LINE TREATMENT OF OROPHARYNGEAL CANCER irasia.com ↗
2026-07-28 Corbus Pharmaceuticals Inc. Regulatory Corbus Pharmaceuticals Announces FDA Clearance to Initiate TEMPO-1 Registrational Study of CRB-701 in Patients with 2L Oropharyngeal Cancer corbuspharma.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has cleared the start of the Company’s registrational study (“TEMPO-1”) of CRB-701, a next-generation Nectin-4 targeted antibody drug conjugate (ADC), in second-line (2L) oropharyngeal squamous cell carcinoma (OPSCC).
2026-05-26 Corbus Pharmaceuticals Inc. Results Corbus Pharmaceuticals Reports Updated CRB-701 Phase 1/2 Clinical Data Demonstrating Robust Activity in 2L Oropharyngeal and Cervical Cancers corbuspharma.com ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”) today reported updated data from its Phase 1/2 clinical study ( NCT06265727) of CRB-701 (SYS6002), a next-generation Nectin-4 targeted antibody drug conjugate (ADC).
2025-10-18 Corbus Pharmaceuticals Inc. Results Corbus Pharmaceuticals Presents CRB-701 Robust Clinical Responses in HNSCC and Cervical Cancers at ESMO25 corbuspharma.com ↗
3.6 mg/kg dose generated ORR of 47.6% in HNSCC, 37.5% in cervical cancer and 55.6% in mUC
2025-09-16 Corbus Pharmaceuticals Inc. Regulatory FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma corbuspharma.com ↗
2025-02-14 Corbus Pharmaceuticals Inc. Results CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting ADC Demonstrates Encouraging Safety and Broader Efficacy in Phase 1 Study in the US and UK Presented at ASCO-GU 2025 corbuspharma.com ↗
2024-12-04 CSPC ZhongQi Pharmaceutical Technology Co., Ltd. Regulatory VOLUNTARY ANNOUNCEMENT - CRB-701 (SYS6002) GRANTED FAST TRACK DESIGNATION BY THE U.S. FDA irasia.com ↗
CRB-701 (SYS6002) GRANTED FAST TRACK DESIGNATION BY THE U.S . FDA
2024-12-03 Corbus Pharmaceuticals Inc. Regulatory FDA Grants Fast Track Designation to CRB-701 for the Treatment of Relapsed or Refractory Metastatic Cervical Cancer corbuspharma.com ↗
2024-06-01 Corbus Pharmaceuticals Inc. Results SYS6002 (CRB-701) A Next-Generation Nectin-4 Targeting Antibody Drug Conjugate Continues to Demonstrate Encouraging Safety and Efficacy Observed in Patients with Nectin-4 Positive Tumors in a Clinical Update Presented at ASCO 2024 corbuspharma.com ↗
The poster presents data as of the end of April 2024 from the dose escalation spanning 7 dose levels (0.2, 0.6, 1.2, 1.8, 2.7, 3.6 & 4.5 mg/Kg Q3W) and PK cohorts (2.7 and 3.6 mg/Kg).
2024-01-26 Corbus Pharmaceuticals Inc. Results CRB-701 (SYS6002) A Next Generation Nectin-4 Targeting Antibody Drug Conjugate Demonstrates Encouraging Safety and Efficacy in Patients with Nectin-4 Positive Tumors in First-In-Human Study Presented at ASCO-GU 2024 corbuspharma.com ↗
A mixed tumor population (n=7) receiving doses of 2.7 mg/kg or 3.6 mg/kg demonstrated an ORR of 43% (3 partial responses -2 unconfirmed and one non-responding participant with no-nectin-4 expression) and a disease control rate of 71%.
2023-10-16 Corbus Pharmaceuticals Inc. Results Corbus Pharmaceuticals Presents the First Pre-Clinical Characterization of its Next Generation Nectin-4 ADC CRB-701 corbuspharma.com ↗
CRB-701 demonstrates statistically significant tumor growth inhibition in preclinical models that express mid- and high-levels of nectin-4, similar to EV.
2023-08-08 Corbus Pharmaceuticals Inc. Results Corbus Pharmaceuticals Reports Second Quarter 2023 Financial Results and Provides Corporate Update corbuspharma.com ↗
Preliminary clinical data generated to date demonstrates a differentiated pharmacokinetic profile relative to other Nectin-4 targeting agents.

All press releases naming this drug 26 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as CRB-701 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06265727 ↗
Modality Other / unclassified “Nectin-4 targeted Antibody Drug Conjugate (ADC)” NCT06265727 ↗
Route Intravenous “intravenous infusion” NCT06265727 ↗