SYS6043 / CSPC Pharma - LARVOL DELTA

A Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of SYS6043 ± Bevacizumab ± Chemotherapy in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=400 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P1/2 trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2 • MUC16

Safety and efficacy of SYS6043, a Novel B7-H3–Targeting Antibody-Drug Conjugate, in Patients with Advanced breast cancer (ESMO 2026) - No abstract available

ADC • Clinical • Metastases • Breast Cancer • Oncology • Solid Tumor

A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

First-in-human study of SYS6043, a novel B7-H3–targeting antibody-drug conjugate, in patients with advanced pan-tumor malignancies. (ASCO 2026) - P1 | "SYS6043 demonstrated a manageable safety profile and robust, cross-tumor antitumor activity in a large population of patients with advanced solid tumors. The magnitude and consistency of responses across multiple histologies, including treatment-refractory tumors such as SCLC, support SYS6043 as a promising therapeutic candidate warranting further clinical and translational investigation."

ADC • Clinical • First-in-human • Metastases • P1 data • Pan tumor • Breast Cancer • Cervical Cancer • Endometrial Cancer • Febrile Neutropenia • Gastroenterology • Gastrointestinal Disorder • Hematological Malignancies • Leukemia • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Nasopharyngeal Carcinoma • Neutropenia • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor

Evaluate the Safety and Efficacy of Combination Therapy With SYS6090 Injection for Hepatocellular Carcinoma (clinicaltrials.gov) - P1/2 | N=288 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P1/2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of SYS6043 in Platinum-Resistant, Advanced Ovarian, Primary Peritoneal, or Fallopian Tube Cancers (clinicaltrials.gov) - P3 | N=460 | Not yet recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

New P3 trial • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

CSPC Pharmaceutical Group has initiated a randomized, multicenter Phase III clinical trial in China for SYS6043, a B7-H3-targeting antibody-drug conjugate, to treat patients with platinum-resistant advanced ovarian, primary peritoneal and fallopian tube cancers. (TipRanks)

Trial status • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

"Outstanding" ADC Candidates Emerge for SCLC, Other Cancers. (PubMed, Cancer Discov) - "The treatment arsenal for small cell lung cancer could soon include antibody-drug conjugates, with early data from three phase I studies indicating robust response rates to CD56-targeting DXC006, DLL-3-targeting BL-M14D1, and B7-H3-targeting SYS6043. The latter also appears active in other tumor types, including ovarian and breast cancers. As well, phase II findings on a fourth ADC candidate, HER2-targeting trastuzumab brengitecan, suggest its strong efficacy in platinum-resistant ovarian cancer."

Journal • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Small Cell Lung Cancer • Solid Tumor • DLL3 • HER-2 • NCAM1

CSPC Pharmaceutical Group announced that its humanised antibody-drug conjugate SYS6043, targeting B7-H3, has received Breakthrough Therapy Designation in China for use as a monotherapy in platinum-resistant ovarian cancer, primary peritoneal carcinoma and fallopian tube cancer. (TipRanks) - "The designation follows clinical data showing SYS6043 can double progression-free survival versus current non-platinum regimens and mirvetuximab soravtansine, while maintaining a favourable safety profile...The company has begun a Phase III confirmatory trial for these gynaecological indications..."

Breakthrough therapy • New P3 trial • Non-US regulatory • Platinum resistant • Fallopian Tube Cancer • Ovarian Cancer • Peritoneal Cancer

SYS6043, a B7-H3 targeting antibody-drug conjugates in patients with advanced gynecologic cancers: a phase 1/2, first-in-human study (SGO 2026) - No abstract available

ADC • Clinical • First-in-human • Metastases • P1/2 data • Gynecologic Cancers • Oncology

Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=386 | Recruiting | Sponsor: Conjupro Biotherapeutics, Inc.

New P1 trial • Breast Cancer • Castration-Resistant Prostate Cancer • Estrogen Receptor Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor

Phase 1/II Clinical Study of SYS6043 in the Treatment of Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1/2 | N=820 | Recruiting | Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.

First-in-human • IO biomarker • New P1/2 trial • Hepatocellular Cancer • Prostate Cancer • Solid Tumor • CD276 • PD-L1

Phase I/II clinical study of SYS6043 combined with PD-1/PD-L1 inhibitor ± chemotherapy in the treatment of advanced solid tumor participants (ChiCTR) - P1/2 | N=622 | Not yet recruiting | Sponsor: Sun Yat-sen University Cancer Center; Sun Yat-sen University Cancer Center

New P1/2 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

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

SYS6043 (ANTIBODY-DRUG CONJUGATE) OBTAINS CLINICAL TRIAL APPROVAL IN THE U.S. (HKEXnews) - "The board of directors (the 'Board') of CSPC Pharmaceutical Group Limited...is pleased to announce that the Investigational New Drug (IND) application for SYS6043 (Antibody-Drug Conjugate) (the 'Product') developed by the Group has been approved by the U.S. Food and Drug Administration (FDA) to conduct clinical trial in the U.S....The indication for this approval is advanced/metastatic solid tumors, and the Product is expected to be indicated for the treatment of small cell lung cancer, esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, prostate cancer and hepatocellular carcinoma."

IND • Esophageal Squamous Cell Carcinoma • Hepatocellular Cancer • Prostate Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck