GSK5733584 / Jiangsu Hansoh Pharma, GSK - LARVOL DELTA

HS-10502 Combination Treatment in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=157 | Recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Gastric Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

THE NMPA HAS GRANTED BREAKTHROUGH-THERAPY-DESIGNATED DRUG FOR B7-H4-TARGETED ANTIBODY-DRUG CONJUGATE HS-20089 (HKEXnews) - "The board of directors (the 'Board') of Hansoh Pharmaceutical Group Company Limited (the 'Company' and together with its subsidiaries, the 'Group') is pleased to announce that, on May 1, 2025, the Group’s self-developed B7-H4-targeted antibody-drug conjugate ('ADC') HS-20089 for injection (the 'Product') has obtained approval to be included as Breakthrough-Therapy Designated Drug by the National Medical Products Administration (NMPA) of China, with the proposed indication for platinum-resistant recurrent epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer patients."

Breakthrough therapy • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Peritoneal Cancer

BEHOLD-1: A Phase 1 Dose Escalation Study of GSK5733584, a B7-H4-Targeted Antibody-Drug Conjugate, in Patients With Advanced Solid Tumors, Including Dose Expansion in Patients With Endometrial and Platinum-Resistant Ovarian Cancer (AACR 2025) - P1 | "Tissue, blood, and urine samples will be collected for biomarker/PK evaluations. Results will be reported using descriptive statistics and 95% confidence intervals.This abstract was previously presented at SGO 2025.Funding: GSK (study 222730)."

Clinical • Metastases • P1 data • Platinum resistant • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • MUC16 • VTCN1

B7 Homolog 4 (B7-H4)-Directed Agents in Oncology Clinical Trials: A Review. (PubMed, J Immunother Precis Oncol) - "B7-H4-directed agents, particularly antibody-drug conjugates (ADCs) like puxitatug samrotecan (AZD8205), felmetatug vedotin (SGN-B7H4V), and GSK5733584, have demonstrated early clinical activity with promising response rates in triple-negative breast cancer (TNBC). Combination strategies, such as ADCs with anti-PD-1 or PARP inhibitor therapies, have also shown enhanced tumor regression in preclinical models and are the subject of several ongoing clinical trials. This review highlights the current landscape of B7-H4-targeted agents, their progress in clinical trials, and the potential for combination approaches to improve outcomes in B7-H4-expressing cancers."

Journal • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • VTCN1

BEHOLD-2: A Study of GSK5733584 in Combination With Anti-cancer Therapies for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=360 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Gynecologic Cancers • Oncology • Solid Tumor

A Phase 1 Dose Escalation Study of GSK5733584, a B7-H4-Targeted Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors, including Dose Expansion in Patients with Endometrial and Platinum-Resistant Ovarian Ca (SGO 2025) - No abstract available

Clinical • Metastases • P1 data • Oncology • Ovarian Cancer • Solid Tumor • VTCN1

HS-20089 for Injection in Patients With Platinum-Resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=468 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

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

BEHOLD-2: A Study of GSK5733584 in Combination With Anti-cancer Therapies for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=360 | Not yet recruiting | Sponsor: GlaxoSmithKline | Phase classification: P1 ➔ P1/2 | Trial primary completion date: Jan 2027 ➔ Sep 2027

Phase classification • Trial primary completion date • Gynecologic Cancers • Oncology • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Jan 2027 ➔ Jun 2027

Trial completion date • Oncology • Solid Tumor

A Study of GSK5733584 in Combination With Anti-cancer Therapies for Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=360 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P1 trial • Gynecologic Cancers • Oncology • Solid Tumor

HS-10502 Combination Treatment in Patients with Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=154 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Breast Cancer • Gastric Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor • Triple Negative Breast Cancer

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

Hansoh Pharmaceuticals' three new Category 1 cancer drugs approved for clinical trials! PARP1 inhibitor and ADC combination therapy [Google translation] (Sina Corp) - "On August 23, the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration announced that three of Hansoh Pharmaceutical's Category 1 cancer drugs under development were approved for clinical trials. They are: (i) HS-10502 tablets, combined with enzalutamide or abiraterone acetate tablets (II), or apatinib or albumin-paclitaxel or docetaxel or irinotecan liposome or HS-20093 or HS-20089 or HS-20089 + bevacizumab for the treatment of patients with advanced solid tumors; (ii) HS-20089 for injection , combined with HS-10502 tablets, is intended for the treatment of patients with advanced solid tumors; (iii) HS-20093 for injection , combined with HS-10502 tablets, is intended for the treatment of patients with advanced solid tumors."

New trial • Solid Tumor

HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=1048 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Oncology • Solid Tumor

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Clinical Activity of GSK5733584 for Injection in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=240 | Not yet recruiting | Sponsor: GlaxoSmithKline

Metastases • New P1 trial • Oncology • Solid Tumor

A Study of HS-20089 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=177 | Recruiting | Sponsor: Shanghai Hansoh Biomedical Co., Ltd | Trial completion date: Dec 2023 ➔ Dec 2026 | Trial primary completion date: Dec 2023 ➔ Dec 2024

Metastases • Trial completion date • Trial primary completion date • Oncology • Solid Tumor

HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer (clinicaltrials.gov) - P2 | N=460 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

HS-20089 Combination Treatment in Subjects With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=1048 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

Metastases • New P1 trial • Oncology • Solid Tumor

First-in-human/phase I trial of HS-20089, a B7-H4 ADC, in patients with advanced solid tumors (YIR 2024) - "Based on data from the ongoing study, HS-20089 was well tolerated and showed antitumor activities in advanced solid tumors, with encouraging clinical efficacy in TNBC."

Clinical • Metastases • P1 data • Anemia • Anorexia • Breast Cancer • Cardiovascular • Endometrial Cancer • Fatigue • Heart Failure • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Ovarian Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • VTCN1

First-in-human/phase I trial of HS-20089, a B7-H4 ADC, in patients with advanced solid tumors (ESMO 2023) - P1 | "The patient achieving PR with the longest treatment duration of 403 days remains on treatment in 0.7 mg/kg cohort. Conclusions Based on data from the ongoing study, HS-20089 was well tolerated and showed antitumor activities in advanced solid tumors, with encouraging clinical efficacy in TNBC."

Clinical • Metastases • P1 data • Breast Cancer • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor • Triple Negative Breast Cancer • VTCN1

GSK enters exclusive license agreement with Hansoh for HS-20089 (GSK Press Release) - "GSK plc...and Hansoh Pharma...announced that they have entered into an exclusive license agreement for HS-20089, a B7-H4 targeted antibody-drug conjugate (ADC) currently in phase I (NCT05263479) clinical trials in China. Under the agreement, GSK will obtain exclusive worldwide rights (excluding China’s mainland, Hong Kong, Macau, and Taiwan) to progress development and commercialisation of HS-20089....HS-20089 complements GSK’s oncology portfolio and strategic disease area focus, including potential future combinations. GSK plans to begin phase I trials outside of China in 2024....Under the terms of this agreement, GSK will pay an $85 million upfront payment. In addition, Hansoh will be eligible to receive up to $1.485 billion in success-based milestones for HS-20089."

Licensing / partnership • New P1 trial • Solid Tumor

HS-20089 in Patients With Ovarian Cancer and Endometrial Cancer (clinicaltrials.gov) - P2 | N=460 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

Metastases • New P2 trial • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor