BG-C9074 / BeOne Medicines, DualityBio - LARVOL DELTA

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Other Anticancer Therapies in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=308 | Recruiting | Sponsor: BeOne Medicines | N=227 ➔ 308

Enrollment change • First-in-human • Monotherapy • Oncology • Solid Tumor

First-in-human study of BG-C9074, a B7-H4-targeting ADC in patients with advanced solid tumors: Preliminary results of the dose-escalation phase. (ASCO 2025) - P1 | " BG-C9074-101 (NCT06233942) is a first-in-human, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity (per RECIST v1.1) of BG-C9074 as monotherapy and in combination with tislelizumab in patients with advanced solid tumors. BG-C9074 showed a manageable safety/tolerability profile in patients with B7-H4 advanced solid tumors. Preliminary clinical responses were observed at multiple dose levels across various tumor types without selection for B7H4 expression. Dose-escalation and dose-level expansion are ongoing and updated clinical data will be presented at the conference."

Clinical • Metastases • P1 data • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Endometrial Cancer • Fatigue • Febrile Neutropenia • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • Thrombocytopenia • VTCN1

BG-C9074, a B7-H4-targeting ADC (Abstract #3033) (Businesswire) - P1a/1b | N=227 | NCT06233942 | Sponsor: BeiGene | "BeOne presented initial results of the ongoing first-in-human, Phase 1a dose escalation study of BG-C9074 monotherapy in 78 patients with advanced solid tumors, of which more than a quarter were breast cancer patients....With limited follow-up among the 56 efficacy-evaluable patients, preliminary clinical responses were observed at multiple dose levels across various tumor types without selection for B7-H4 expression in these heavily pretreated patients. Confirmed overall response rate (ORR) was 16.1% (9/56; 95% CI: 7.6%–28.3%), with 9 confirmed partial responses; unconfirmed ORR was 25.0% (14/56; 14.4%-38.4%) (n=14 partial responses). Confirmed disease control rate (DCR) was 73.2% (59.7%-84.2%) and confirmed clinical benefit rate (CBR) was 17.9% (8.9%-30.4%). Pharmacokinetics (PK) were observed to be approximately dose-proportional across dose levels."

P1 data • Breast Cancer • Solid Tumor

BeiGene Presents Pioneering Cancer Research at ASCO 2025 – Redefining Treatment Across Hematology and Solid Tumors (Businesswire) - "BeiGene, Ltd...announced it will share 23 abstracts featuring new data across its hematology and solid tumor portfolio at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, May 30 – June 3, 2025. With two abstracts selected for rapid oral presentation, these data reflect the Company’s vision to address cancer across multiple fronts and provide innovative medicines to as many patients as possible worldwide."

Clinical data • Chronic Lymphocytic Leukemia • Esophageal Squamous Cell Carcinoma • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Nasopharyngeal Carcinoma • Non Small Cell Lung Cancer • Small Lymphocytic Lymphoma • Squamous Cell Carcinoma of Head and Neck

Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=227 | Recruiting | Sponsor: BeiGene | N=150 ➔ 227 | Trial completion date: Sep 2027 ➔ May 2028

Enrollment change • Monotherapy • Trial completion date • Solid Tumor

BeiGene Announces Fourth Quarter and Full Year 2024 Financial Results and Business Updates (Businesswire) - "Anticipate data readouts for BGB-43395 (CDK4 inhibitor), BG-68501 (CDK2 inhibitor) and BG-C9074 (B7H4 ADC) in the first half of 2025"

Clinical data • P1 data • Oncology • Solid Tumor

Duality Biologics Announces B7H4 ADC Milestone Achievement and License Exercise by BeiGene (PRNewswire) - "Duality Biologics...announced that, BeiGene. Ltd. has exercised its exclusive option for the B7H4 antibody-drug conjugate (ADC) DB1312/BG-C9074 from DualityBio, securing global development, manufacturing, and commercialization rights for the investigational product. In 2024, DualityBio received an option exercise fee and a milestone payment based on the Phase I dose-escalation advancement. In July 2023, DualityBio announced an agreement for BeiGene to acquire its exclusive option for a global clinical and commercial license to an investigational, preclinical ADC therapy for patients with select solid tumors. Under the terms of the agreement, DualityBio received an upfront payment, and is eligible for a payment contingent upon BeiGene exercising its option..."

Licensing / partnership • Solid Tumor

BeiGene Reports First Quarter 2024 Financial Results and Business Updates (Businesswire) - "BGB-43395 (CDK4 inhibitor): Initiated fourth dose level of monotherapy, which is in the efficacious dose range with no dose limiting toxicities observed; and initiated dosing of combination with fulvestrant just over four months from first monotherapy dose. BG-68501 (CDK2 inhibitor): Initiated second dose level of monotherapy in first-in-human study, with clinical pharmacokinetics as expected and no dose limiting toxicities observed. BG-C9074 (B7H4 ADC): First patient dosed in Australia in global first-in-human Phase 1 study."

Trial status • Endometrial Cancer • Gastric Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Solid Tumor

Study of BG-C9074 as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Recruiting | Sponsor: BeiGene | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Metastases • Monotherapy • Oncology • Solid Tumor

Study of BG-C9074 as Monotherapy and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=150 | Not yet recruiting | Sponsor: BeiGene

New P1 trial • Oncology • Solid Tumor