risvutatug rezetecan (GSK5764227) / Jiangsu Hansoh Pharma, GSK - LARVOL DELTA

A Study of GSK5764227 in Combination With Standard of Care (SoC) or Other Agents in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=72 | Not yet recruiting | Sponsor: GlaxoSmithKline

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

ARTEMIS-001: A phase I study of HS-20093 (GSK5764227) in patients with non-small cell lung cancer (NSCLC) (ESMO Asia 2025) - P1 | "HS-20093 demonstrated anti-tumour activity in pts with NSCLC, particularly for those with adeno without AGA. The overall benefit:risk profile was more favourable for 8.0 mg/kg compared with 10.0 mg/kg; the 8.0 mg/kg dose is being investigated further in pts with NSCLC."

Clinical • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma

A phase 1b/2, multicenter, open-label study to evaluate the efficacy and safety of GSK5764227 (GSK'227), alone and in combination in patients with previously treated advanced unresectable or metastatic gastrointestinal solid tumors. (ASCO-GI 2026) - P1/2 | "Funded by GSK Clinical Trial Registration Number: NCT06885034 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Metastases • P1/2 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=63 | Recruiting | Sponsor: Hansoh BioMedical R&D Company | Not yet recruiting ➔ Recruiting

Enrollment open • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Phase 0/1 Clinical Trial With an Expansion Phase of GSK5764227, a B7-H3-Targeted Antibody-Drug Conjugate (ADC), in Patients With Recurrent Grade 4 Glioma and Patients With Brain Metastases (clinicaltrials.gov) - P1 | N=15 | Not yet recruiting | Sponsor: Nader Sanai

New P1 trial • Brain Cancer • Glioblastoma • Glioma • Oncology • Solid Tumor

GSK’227, a B7-H3-targeted antibody-drug conjugate, granted Orphan Drug Designation in small-cell lung cancer by the US FDA (GSK Press Release) - "The ODD was supported by preliminary clinical data showing durable responses in patients with extensive stage SCLC (ES-SCLC) who were treated with risvutatug rezetecan in the phase I ARTEMIS-001 clinical trial."

Orphan drug • Small Cell Lung Cancer

A Study of SHR3680, HS-20093 and SHR2554 in Subjects With Prostate Cancer (clinicaltrials.gov) - P2 | N=218 | Not yet recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

ARTEMIS-002: A PHASE 2 STUDY OF HS-20093 IN PATIENTS WITH RELAPSED OR REFRACTORY SARCOMAS (CTOS 2025) - No abstract available

Clinical • P2 data • Oncology • Sarcoma • Solid Tumor

First-Time-in-Human Study of GSK4381562 in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=158 | Recruiting | Sponsor: GlaxoSmithKline | Trial completion date: Sep 2028 ➔ Aug 2027 | Trial primary completion date: Sep 2028 ➔ Aug 2027

Monotherapy • Trial completion date • Trial primary completion date • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastric Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

ARTEMIS-002: A phase II study of HS-20093 in patients with relapsed or refractory sarcomas (ESMO 2025) - P2 | "Table: 2684O Efficacy Osteosarcoma (39 Adults and 5 adolescents) Other Sarcomas 8.0 mg/kg (N=15) 12.0 mg/kg (N=29) 12.0 mg/kg (N=20) ORR, % 6.7 17.2 25.0 DCR, % 66.7 86.2 85.0 mDoR, months NA NA 5.7 mPFS, months 4.0 8.4 8.2 6 months PFS, % 33.3 59.7 62.3 Median F/U, months 16.4 10.8 15.4 * Cut-off date: 3 March, 2025; ORR=Objective response rate; DCR=Disease control rate; F/U=Follow-up; mDoR=Median duration of response; mPFS=Median progression-free survival; mOS=Median overall survival; NA=Not available. Conclusions HS-20093 demonstrated promising emerging efficacy with manageable safety profile in heavily pretreated R/R sarcomas pts, supporting further clinical development."

Clinical • P2 data • Oncology • Osteosarcoma • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

GSK PLC…has secured Orphan Drug Designation in the European Union for GSK5764227, also known as GSK’227, a B7-H3-targeted antibody-drug conjugate being tested in small-cell lung cancer (SCLC). (Proactiveinvestors) - "The decision is based on early clinical signals from the phase I ARTEMIS-001 study, where patients with extensive-stage SCLC who had relapsed after prior therapy showed durable responses."

Orphan drug • Small Cell Lung Cancer

ESMO 2025 | Hansoh Pharma Announces Proffered Paper Presentation of Phase 2 Study on HS-20093 (B7-H3-targeted ADC) in Relapsed or Refractory Sarcomas (Hansoh Pharma Press Release) - "HS-20093 administered at 12 mg/kg Q3W showed a trend towards better survival benefit compared to 8 mg/kg in patients with osteosarcoma. With a median follow-up duration of 19.6 months for those receiving 8.0 mg/kg and 16 months for those receiving 12.0 mg/kg, The confirmed objective response rate (cORR) was 6.7% in the 8.0 mg/kg group and 20.0% in the 12.0 mg/kg group....A total of 13 STS patients were enrolled. With a median follow-up duration of 19.0 months, cORR was 23.1%, DCR was 92.3%, the median PFS was 9.4 months, and median OS was 22.6 months."

P2 data • Osteosarcoma • Soft Tissue Sarcoma

GSK acquires rights to prostate-cancer candidate from Syndivia for up to £268 million (Indian Pharma Post) - "These diverse approaches, such as GSK’227 and this novel ADC, enable GSK to advance potential therapeutic options across various stages and types of prostate cancer....Under the terms of the agreement, Syndivia will receive an upfront payment as well as success-based development and commercial milestone payments up to a total of £268 million. They will also receive tiered royalties on future product sales worldwide. GSK will assume full responsibility for the development, manufacturing, and worldwide commercialisation of the ADC program."

Commercial • Castration-Resistant Prostate Cancer

Evaluation of the Effect of Itraconazole on the Pharmacokinetics of HS-20093 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P1 trial • Solid Tumor

Progress on 14 key opportunities expected to launch 2025-2031 each with PYS potential above £2 billion (GSK Press Release) - "Phase III development programme for depemokimab COPD started with launch of ENDURA studies; Pivotal/Phase III trial starts planned in H2 25 for: potential cancer treatments GSK'227 B7H3 ADC for ES-SCLC and GSK'981 IDRx-42 for 2L GIST; efimosfermin for treatment of MASH"

New P3 trial • Trial status • Chronic Obstructive Pulmonary Disease • Gastrointestinal Stromal Tumor • Metabolic Dysfunction-Associated Steatohepatitis • Small Cell Lung Cancer

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P3 | N=300 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase Ib Study of HS-20093+HRS-5041 in Patients With Advanced Prostate Cancer (clinicaltrials.gov) - P1 | N=63 | Not yet recruiting | Sponsor: Hansoh BioMedical R&D Company

New P1 trial • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (clinicaltrials.gov) - P1/2 | N=320 | Recruiting | Sponsor: GlaxoSmithKline | N=200 ➔ 320 | Trial completion date: Feb 2028 ➔ Jun 2028 | Trial primary completion date: Nov 2026 ➔ Nov 2027

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

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) (clinicaltrials.gov) - P3 | N=300 | Not yet recruiting | Sponsor: GlaxoSmithKline

New P3 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase 1 Study of HS-20093 Combinations in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov) - P1 | N=50 | Not yet recruiting | Sponsor: Shanghai Hansoh Biomedical Co., Ltd

New P1 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

A Study to Test the Safety and Effectiveness of GSK5764227, Alone or With Other Treatments, in Participants With Advanced Gastrointestinal Cancers That Cannot be Surgically Removed (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: GlaxoSmithKline | Not yet recruiting ➔ Recruiting | N=120 ➔ 200

Enrollment change • Enrollment open • Gastrointestinal Cancer • 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

A phase 1 dose escalation/expansion study of GSK5764227, a B7-homolog 3 protein targeted antibody-drug conjugate, in combination with standard of care in patients with advanced solid tumors (AACR 2025) - P1, P2 | "Patients will receive intravenous GSK'227 every 3 weeks (Q3W) as monotherapy or in combination with SoC (Combination [Comb.] 1: cisplatin/carboplatin + atezolizumab/durvalumab/pembrolizumab; Comb...3: folinic acid + fluorouracil [FOLF] + bevacizumab; Comb. 4: FOLF + cetuximab) until progression, toxicity, loss to follow-up, or death...Curigliano G, et al. Presented at ESMO-IO 2024 (Poster 168TiP), 11-13 Dec, Geneva, Switzerland."

Clinical • Combination therapy • Metastases • P1 data • Oncology • Solid Tumor • CD276

A Phase Ib Study of HS-10370 in Addition to Other Anti-cancer Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=762 | Not yet recruiting | Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd.

New P1 trial • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Overall safety of HS-20093, a B7-H3-directed antibody-drug conjugate in Chinese patients with advanced solid tumors [WITHDRAWN] (AACR 2025) - P1, P2 | "HS-20093 at doses ranging from 8.0 to 12.0 mg/kg consistently showed an acceptable safety profile across different types of solid tumors. These doses are being further evaluated in a variety of studies for solid tumors.Overall safety of HS-20093 at 8.0 to 12.0 mg/kg dose8 mg/kg (N=330)10 mg/kg (N=114)12 mg/kg (N=64)Total (N=508)Median follow-up time, months4.88.79.35.8TEAE, %99.1100.098.499.2Grade ≥3 TEAE, %57.674.695.366.1TEAE leading to dose interruption, %32.449.156.339.2TEAE leading to dose reduction, %11.541.256.323.8TEAE leading to treatment discontinuation, %3.98.810.95.9SAE, %33.054.460.941.3Treatment related TEAE leading to death, %1.54.46.32.8"

Clinical • Metastases • Castration-Resistant Prostate Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Sarcoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma • Urothelial Cancer • CD276