BG-C9074 / BeOne Medicines, DualityBio - LARVOL DELTA

Efficacy and Safety of BG-C9074 With Bevacizumab Compared With Bevacizumab in Adults With Ovarian, Fallopian Tube, or Primary Peritoneal Cancers (clinicaltrials.gov) - P3 | N=600 | Not yet recruiting | Sponsor: BeOne Medicines

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

Consideration of adjusted ideal body weight dosing in BG-C9074 (B7-H4–targeting ADC) from pharmacokinetics, efficacy, and safety perspectives. (ASCO 2026) - P1 | "AiBW dosing effectively reduced PK variability compared with TBW dosing, providing more consistent exposure across BW. Higher ADC exposure was associated with increased efficacy, but also with a higher incidence of manageable TRAEs. AiBW optimizes the risk-benefit profiles across BW."

ADC • Clinical • First-in-human • PK/PD data • Neutropenia • Oncology • Ovarian Cancer • Solid Tumor • VTCN1

BG-C9074: "Efficacy in ovarian cancer target dose levels (doses 6.5, 7, 8 mg/kg AIBW, 22 patients): cORR 45.5% including 2 CRs, uORR 54.5%, DCR 100.0%, Clinical responses in OC were observed across all levels of B7-H4 expression, supporting all-comer development"; Ovarian Cancer (BeOne Medicines) - ASCO 2026

P1 data • Gynecologic Cancers • Oncology • Ovarian Cancer

BG-C9074: Initiation of P3 trial in combination with bevacizumab for 1L ovarian cancer in Q4 2026 (BeOne Medicines) - ASCO 2026

New P3 trial • Gynecologic Cancers • Oncology • Ovarian Cancer

First-in-human study of BG-C9074 (B7-H4–targeting ADC) in advanced solid tumors: Dose escalation and safety expansion. (ASCO 2026) - P1 | "BG-C9074 demonstrates a tolerable safety profile in pts with advanced solid tumors. Encouraging antitumor activity was observed in OC and TNBC. Dose expansion and optimization are ongoing."

ADC • Clinical • First-in-human • Metastases • P1 data • Biliary Cancer • Breast Cancer • Cholangiocarcinoma • Febrile Neutropenia • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Infectious Disease • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thrombocytopenia • Triple Negative Breast Cancer • HER-2 • VTCN1

…Oral presentations at ASCO highlight rapid acceleration of BeOne’s solid tumor pipeline (Businesswire) - "Key data presentations across our solid tumor programs include: (i) First disclosure of anti-tumor effects and safety/tolerability profile of the highly selective CDK4 inhibitor BGB-43395 Phase 1 treatment data in first-line HR-positive/HER2-negative breast cancer; (ii) Rapid oral presentation on BG-C9074, a promising B7-H4-targeting ADC, with Phase 1 dose escalation and safety expansion data; (iii) Rapid oral presentation on BGB-B2033, a potentially first-in-class GPC3 x 4-1BB bispecific antibody, with first clinical data of a Phase 1 study in heavily pre-treated hepatocellular carcinoma patients."

P1 data • Hepatocellular Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer

First Quarter 2026 Business Highlights: Select Clinical-Stage Programs (Businesswire) - "Hematology: BGB-16673 (BTK CDAC): Initiated Phase 2 cohorts in R/R MZL and Richter’s Transformation. Breast and Gynecological Cancers: BGB-43395 (CDK4 inhibitor): Received acceptance of Phase 1 study data as a poster presentation at ASCO. BG-C9074 (B7-H4 ADC): Received acceptance of Phase 1 study data as a rapid oral presentation at ASCO."

P1 data • Trial status • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Marginal Zone Lymphoma • Solid Tumor

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