GSK5733584 / Jiangsu Hansoh Pharma, GSK - LARVOL DELTA

BEHOLD-2: A phase I/II randomized study evaluating mocertatug rezetecan, a B7-H4-targeted antibody-drug conjugate, in combination with anti-cancer agents in patients with solid tumors (ESMO Asia 2025) - P1/2 | "GSK'584 will be combined with dostarlimab (500 mg every 3 weeks [Q3W]) in patients with EC (Module 1) and with bevacizumab (15 mg/kg Q3W) in patients with OC (Module 2). Wu J, et al. Ann Oncol 2023; 34(suppl2):Abstr3810."

Clinical • Combination therapy • P1/2 data • Endometrial Cancer • Oncology • Solid Tumor • VTCN1

HANSOH PHARMA ANNOUNCES ORAL PRESENTATION OF PHASE 2 STUDY FINDINGS OF HS-20089 (B7-H4 ADC) IN PLATINUM-RESISTANT OVARIAN CANCER AT IGCS 2025 (Hansoh Pharma Press Release) - "As of the June 20, 2025 data cutoff, HS-20089 is the first B7-H4 ADC to demonstrate promising efficacy in heavily pretreated patients with platinum-resistant ovarian cancer (PROC) who were not selected based on tumor B7-H4 expression. It showed a confirmed ORR of 48.5% and DoR of 6.8 months, a mPFS of 6.4 months and a mOS of 14.6 months. The efficacy was analyzed in all patients who received treatment, with a median follow-up time of 11.5 months."

P2 data • Platinum resistant • Ovarian Cancer

ESMO 2025 | Hansoh Pharma Presents the phase 2 study findings of HS-20089 (B7-H4-targeted ADC), in patients with platinum-resistant ovarian cancer (PROC) (Hansoh Pharma Press Release) - "At data cut-off, 33 patients with high-grade serous ovarian cancer were enrolled and received at least one dose of HS-20089, comprising the safety set. All patients were heavily pretreated, with a median of 3 prior lines of anti-tumor therapy and 45.5% of patients had a platinum free interval of 3 months or less....Treatment with HS-20089 showed promising efficacy in patients with PROC, with a confirmed ORR of 48.5% and DoR of 6.8 months, a mPFS of 6.4 months and a mOS of 14.6 months."

P2a data • Platinum resistant • Ovarian Cancer

An encored oral presentation of the findings from HS-20089 will be delivered at the IGCS 2025 Annual Global Meeting, which is to be held at the Century City Conference Centre in Cape Town, South Africa, from November 5 to 7, 2025 (Hansoh Pharma Press Release)

Clinical data • Gynecologic Cancers • Oncology

Seminal Abstract: HS-20089 IN PATIENTS WITH PLATINUM-RESISTANT OVARIAN CANCER: AN OPEN-LABEL, MULTI-CENTER, PHASE 2 STUDY (IGCS 2025) - P1, P2 | "No new safety signal was observed. The most common TEAEs of grade ≥3 (occurring in ≥20% of patients) were neutrophil count decreased, anaemia, white blood cell count decreased and platelet count decreased.HS-20089 as monotherapy demonstrated promising clinical activity in PROC patients and showed consistent safety profile with the phase 1 study."

Clinical • P2 data • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • VTCN1

HS-20089 in patients with platinum-resistant ovarian cancer: An open-label, multi-center, phase II study (ESMO 2025) - P1, P2 | "The most common TEAEs of grade ≥3 (occurring in ≥20% of patients) were neutrophil count decreased, anaemia, white blood cell count decreased and platelet count decreased. Conclusions HS-20089 as monotherapy demonstrated promising clinical activity in PROC patients and showed consistent safety profile with the phase 1 study."

Clinical • P2 data • Platinum resistant • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • VTCN1

BEHOLD-2: A Study of GSK5733584 in Combination With Anti-cancer Therapies for Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=392 | Recruiting | Sponsor: GlaxoSmithKline | Trial primary completion date: Sep 2027 ➔ Dec 2027

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

BEHOLD-1: 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=385 | Recruiting | Sponsor: GlaxoSmithKline | N=240 ➔ 385 | Trial primary completion date: Oct 2026 ➔ Feb 2027

Enrollment change • Trial primary completion date • Oncology • Solid Tumor

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