Drugs / SYS6002
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07241936 | Nov 2025 → Oct 2027 expected | cancer | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Recruiting | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT06989671 | Aug 2025 → Dec 2027 expected | head and neck squamous cell carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT07526792 | Jun 2026 → Jun 2029 expected | urothelial carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07230626 | Nov 2025 → Jan 2028 expected | cervical cancer | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2 | NCT07374549 Comparator | Jun 2026 → Jun 2028 expected | urothelial carcinoma | CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 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 ↗
The new data demonstrate robust activity in the second line (2L) setting of two solid tumor types that express high levels of Nectin-4 and are primarily driven by human papilloma virus (HPV): oropharyngeal squamous cell carcinoma (OPSCC) and cervical cancer. |
| 2026-04-07 | Corbus Pharmaceuticals Inc. | Regulatory Corbus Pharmaceuticals Announces Broad Alignment with FDA on Registration Path for CRB-701 in Second-Line HNSCC and Cervical Cancer corbuspharma.com ↗
FDA feedback enables Corbus to proceed with proposed registrational study design and endpoints to support potential accelerated approval in second-line HNSCC and cervical cancer |
| 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 ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage oncology and obesity company, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and an anti-PD(L)-1 therapy. |
| 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 ↗
Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), an oncology and obesity company with a diversified portfolio, announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CRB-701 for the treatment of relapsed or refractory metastatic cervical cancer. |
| 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 ↗
SYS6002 (CRB-701) demonstrated 44% ORR and 78% DCR in mUC and 43% ORR and 86% DCR in cervical cancer to date at doses ≥ 1.2mg/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. |
| 2022-10-27 | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Regulatory VOLUNTARY ANNOUNCEMENT - ANTIBODY-DRUG CONJUGATE "SYS6002" OBTAINS CLINICAL TRIAL APPROVAL irasia.com ↗
ANTIBODY-DRUG CONJUGATE “SYS6002” OBTAINS CLINICAL TRIAL APPROV AL |
All press releases naming this drug 16 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 5 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SYS6002 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06989671 ↗ |
| Modality | Other / unclassified | “anti-nectin-4 ADC” NCT06989671 ↗ |
| Route | Intravenous | “SYS6002 Q2W or Q3W, intravenous injection” NCT06989671 ↗ |