GSK5733584 / Jiangsu Hansoh Pharma, GSK - LARVOL DELTA

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