CRB-701 / CSPC Pharma, Corbus Pharma - LARVOL DELTA

A Study of Sirolimus (Albumin-Bound) in Combination With Different ADCs Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=444 | Recruiting | Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

New P1/2 trial • Solid Tumor

SYS6002 vs Chemotherapy in Recurrent or Metastatic Cervical Cancer (clinicaltrials.gov) - P3 | N=412 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Cervical Cancer • Oncology • Solid Tumor

CRB-701 for the treatment of solid tumors, is a next-generation antibody drug conjugate (ADC) targeting Nectin-4 that contains a site-specific, cleavable linker and a precise drug antibody ratio (DAR) of 2 using monomethyl auristatin E (MMAE) as the payload. (Corbus Pharmaceuticals Press Release) - "The Company plans to meet with the U.S. Food and Drug Administration (FDA) in the first quarter of 2026 to review the data and expects to initiate a Phase 2/3 registrational study by mid-2026."

New P2/3 trial • Squamous Cell Carcinoma of Head and Neck

A Phase II Clinical Study of SYS6002 in combination with SG001 in patients with advanced urothelial cancer and other advanced solid tumor (ChiCTR) - P2 | N=148 | Recruiting | Sponsor: Fudan University Shanghai Cancer Center; CSPC Megalith Biopharmaceutical Co., Ltd..

New P2 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

Phase I/II study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours (ESMO 2025) - P1/2 | "The CRB-701 safety profile was similar to previous reports and as expected for a next-generation, stable linker ADC. Dose optimization is ongoing at 2.7 mg/kg and 3.6 mg/kg, both of which were well tolerated."

Clinical • P1/2 data • Cervical Cancer • Genito-urinary Cancer • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer • NECTIN4

Breakthrough clinical research conducted by Florida Cancer Specialists & Research Institute, LLC (FCS) will be in the spotlight this week in Berlin at the European Society of Medical Oncology (ESMO) Congress 2025. (PRNewswire) - "Among the 23 studies co-authored by FCS physician investigators selected for presentation to oncology experts worldwide, one has earned the distinction of being featured as an oral presentation and four as poster presentations by FCS first authors."

Clinical data • Platinum resistant • pMMR • Cervical Cancer • Endometrial Cancer • Ovarian Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Presents CRB-701 Robust Clinical Responses in HNSCC and Cervical Cancers at ESMO25 (Corbus Pharmaceuticals Press Release) - "3.6 mg/kg dose generated ORR of 47.6% in HNSCC, 37.5% in cervical cancer and 55.6% in mUC...Company to host an HNSCC KOL event during ESMO25...The tumor types being investigated were head and neck squamous cell carcinoma (HNSCC, n=41), cervical cancer (n=37) and locally advanced/metastatic urothelial (mUC, n=23) tumors...No dose limiting toxicities (DLTs) were encountered during dose escalation. The 2.7 mg/kg and 3.6 mg/kg doses were selected for dose optimization...Clinical responses were observed in patients with both high and low Nectin-4 expression as measured retrospectively by immunohistochemistry.,,Responses were observed in patients with both HPV+ and HPV- status....The Company plans to meet with the FDA this year to review the data and expects to initiate registrational studies by mid-2026."

Biomarker • New trial • P1/2 data • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals to Present CRB-701 Phase 1/2 Data at ESMO 2025 (GlobeNewswire) - "...Abstract for its Phase 1/2 clinical study has been released. Updated data will be presented as a poster during ESMO. The abstract describes safety data for 70 participants from an April 2025 data cut. The poster will present updated data from a September 1st, 2025 data cut on 167 enrolled participants of which 122 participants were evaluable for efficacy with either head and neck squamous cell carcinoma (HNSCC)(n=41), cervical(n=37), metastatic urothelial tumors(n=23),or other tumor types enrolled during dose escalation(n=21)."

P1/2 data • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Holdings, Inc…announced that it will host an in-person and virtual KOL event at the European Society for Medical Oncology (ESMO) Congress 2025 to review and discuss dose optimization data from its Phase 1/2 clinical study of CRB-701 (SYS6002). (Corbus Pharmaceuticals Press Release) - "Data from over 100 participants with either head and neck squamous cell carcinoma (HNSCC), cervical, or metastatic urothelial tumors will be presented."

P1/2 data • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

FDA Grants Fast Track Designation to Corbus Pharmaceuticals’ Nectin-4 Targeting ADC CRB-701 in Head and Neck Squamous Cell Carcinoma (Corbus Pharmaceuticals Press Release) - "An ongoing Phase 1/2 clinical trial is evaluating the safety, pharmacokinetics, and efficacy of CRB-701 in patients with advanced solid tumors known to be associated with high Nectin-4 expression."

Fast track • Squamous Cell Carcinoma of Head and Neck

SYS6002 Plus JMT101 and Enlonstobart Injection in Participants With HNSCC (clinicaltrials.gov) - P2 | N=430 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | N=250 ➔ 430 | Initiation date: May 2025 ➔ Aug 2025 | Trial primary completion date: Sep 2027 ➔ Dec 2027

Enrollment change • Trial initiation date • Trial primary completion date • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Reports Second Quarter 2025 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "CRB-701: The Company expects to complete dose optimization and identify the recommended Phase 2 dose (RP2D) in the fourth quarter of 2025....CRB-601: The first participant was dosed in December 2024 in the dose escalation monotherapy portion of a Phase 1 study which is being conducted in the U.S. and Europe. The Company is on track to report dose escalation data in Q4 2025."

P1 data • Trial status • Oncology • Solid Tumor

Corbus Pharmaceuticals Announces Upcoming Presentation of Dose Expansion Phase 1/2 Clinical Data for its Nectin-4 Targeting ADC CRB-701 at the 2025 ESMO Annual Congress (GlobeNewswire) - "Corbus Pharmaceuticals...announced today that an abstract on updated clinical data from its Phase 1/2 clinical study conducted in the United States and Europe of CRB-701 (SYS6002) has been accepted for presentation as a poster at the European Society for Medical Oncology (ESMO) Congress 2025....The abstract, a Phase 1/2 study of the next-generation Nectin-4-targeting antibody–drug conjugate CRB-701 (SYS6002) in patients with urothelial and non-urothelial solid tumours by Perez et al, will be presented as a poster (# 967P) on Sunday, October 19....The three-part Phase 1/2 study (NCT06265727) is evaluating the safety, pharmacokinetics and efficacy of CRB-701 in participants with advanced solid tumors associated with high Nectin-4 expression....Dose optimization is on-going with dosing at 2.7 mg/kg and 3.6 mg/kg cohorts in HNSCC, cervical and mUC tumors. The Company expects to complete dose optimization and identify a recommended Phase 2 dose in the fourth quarter of 2025."

P1/2 data • Trial status • Cervical Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Announces First Patient Dosed with its Nectin-4 Targeting ADC CRB-701 in Combination with Pembrolizumab (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...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)....The Company expects to provide a data update and establish the recommended Phase 2 dose (RP2D) in the fourth quarter of this year."

P1 data • Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

SYS6002 Plus JMT101 and Enlonstobart Injection as First-Line Treatment for HNSCC (clinicaltrials.gov) - P2 | N=250 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P2 trial • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Corbus Pharmaceuticals Reports First Quarter 2025 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "Dose optimization and RP2D determination on schedule for completion in Q4 2025 for the Nectin-4 ADC CRB-701 in HNSCC, cervical and mUC tumors....Dose escalation study on schedule for completion in Q4 2025 for the anti-αvβ8 integrin mAB-CRB-601 in solid tumors."

Trial completion date • Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Reports Q4 and 2024 Financial Results and Provides a Corporate Update (Corbus Pharmaceuticals Press Release) - "CRB-701: Dose optimization is underway with dosing at 2.7 mg/kg and 3.6 mg/kg cohorts in HNSCC, cervical and mUC tumors. More cohorts may be added to address additional tumor types in the expansion phase. The Company expects to complete dose optimization and establish a recommended Phase 2 dose ('RP2D') under Project Optimus in the fourth quarter of 2025....CRB-601 is a potent and selective anti-αvβ8 integrin monoclonal antibody for the treatment of solid tumors....We expect to complete dose escalation in the fourth quarter of 2025."

Trial status • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Phase I dose-escalation study of the next-generation nectin-4 targeting antibody–drug conjugate CRB-701 (SYS6002) in US and UK patients with urothelial cancer and other solid tumors. (ASCO-GU 2025) - P1/2 | "CRB-701, a next-generation nectin-4 targeted ADC, has third-generation linker technology that is specifically designed to reduce the dose-limiting toxicities (DLTs) reported with ADCs (e.g. enfortumab vedotin [EV]). PK, safety and efficacy observations are consistent with those from a previous study in Han Chinese patients. CRB-701 was well tolerated and, relative to EV at similar doses, demonstrated signs of a differentiated PK profile, including a longer half-life and lower free MMAE levels. CRB-701 development will continue to dose expansion."

Clinical • P1 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urothelial Cancer • NECTIN4

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 (Corbus Pharmaceuticals Press Release) - P1/2 | N=420 | NCT06265727 | Sponsor: Corbus Pharmaceuticals Inc. | "PK: PK profile seen in the Western study was comparable to that generated in the China study. CRB-701 demonstrated a longer ADC half-life and lower free-MMAE exposure relative to enfortumab vedotin (EV). Efficacy: A total of 26 participants with eight tumor types were evaluable for efficacy at the time of this data cut. Responses were observed in several tumor types including previously unexplored HNSCC tumors: mUC: Western study (n=4, 1 PR, 1 SD and 2 PD); China study (n=9, ORR 44%). Both mUC PD participants in the Western study were previously treated with EV. Cervical: Western study (n=2, 1 CR and 1PD); China study (n=7, ORR 43%). HNSCC: Western study (n=7, 4 PR, 2 SD and 1 PD)."

P1 data • PK/PD data • Cervical Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Corbus Pharmaceuticals Announces Clinical Data for CRB-701 from Western Dose Escalation Study to be Presented at 2025 ASCO-GU (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...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)."

P1 data • Solid Tumor • Urothelial Cancer

Clinical Studies Conducted at Florida Cancer Specialists & Research Institute Expanding Treatment Options and Improving Outcomes for Patients with Gastrointestinal and Genitourinary Cancers (PRNewswire) - "Clinical research conducted at Florida Cancer Specialists & Research Institute, LLC (FCS) is expanding treatment options and contributing to improved outcomes for patients diagnosed with gastrointestinal and genitourinary cancers. FCS research study results are featured at two global gatherings sponsored by the American Society of Clinical Oncology (ASCO)....At the ASCO 2025 Genitourinary Cancers Symposium, Cesar Augusto Perez, MD, as first author, will present results of a Phase I dose-escalation study of the next-generation nectin-4 targeting antibody–drug conjugate CRB-701 (SYS6002) in US and UK patients with urothelial cancer and other solid tumors."

Clinical data • P1 data • Preclinical • Colorectal Cancer • Gastric Cancer • Urothelial Cancer

Corbus Pharmaceuticals Announces that Clinical Data for CRB-701 from Western Dose Escalation Study to be Presented at ASCO GU 2025 (GlobeNewswire) - "Corbus Pharmaceuticals Holdings...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)...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]."

P1 data • Solid Tumor • Urothelial Cancer

FDA Grants Fast Track Designation to CRB-701 for the Treatment of Relapsed or Refractory Metastatic Cervical Cancer (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...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....Corbus recently completed enrollment of the dose escalation part of its Phase 1 clinical trial of CRB-701 (SYS6002) (NCT06265727) that is being conducted in the U.S. and Europe....The Company expects to report the first data from the dose escalation clinical study in Q1 2025."

Fast track • P1/2 data • Cervical Cancer

Corbus Announces Enrollment Completion of Dose Escalation Stage of Phase 1 Clinical Trial of Its Next Generation Nectin-4 Targeting ADC (CRB-701) (Corbus Pharmaceuticals Press Release) - "Corbus Pharmaceuticals Holdings, Inc...announced today that it has completed enrollment of the dose escalation part of its bridging Phase 1 clinical trial of CRB-701 (SYS6002). The dose escalation part of this open label study (NCT06265727) is being conducted in the US and the UK....The company expects to share the first data from dose escalation in Q1 2025."

Enrollment closed • P1/2 data • Oncology • Solid Tumor

Corbus Pharmaceuticals Reports Second Quarter 2024 Financial Results and Provides a Corporate Update (GlobeNewswire) - "Key Corporate Updates - CRB-701:...Dose escalation commenced in the Phase 1 clinical trial of CRB-701-01 in April 2024. The Phase 1 portion of the open label study design (NCT06265727), being conducted in the U.S. and Europe, will evaluate the safety, efficacy and PK of CRB-701 in participants with advanced solid tumors associated with high nectin-4 expression. The Phase 1 trial initiates with dose escalation followed by dose optimization and concludes with dose expansion to determine the recommended Phase 2 dose. The Company expects to complete the dose escalation phase in Q4 2024 and present the USA dose escalation data in Q1 2025."

P1 data • Trial status • Solid Tumor