XmAb819 / Xencor - LARVOL DELTA

Phase 1 results of XmAb819, a novel ENPP3 x CD3 bispecific, in advanced clear cell renal cell carcinoma (ccRCC) (ESMO 2026) - No abstract available

Bispecific • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

A Phase 1, multiple-dose study to evaluate the safety and tolerability of first-in-class XmAb819 (ENPP3 x CD3) in subjects with relapsed or refractory clear cell renal cell carcinoma (ccRCC) (NCT05433) (KCRS 2025) - "Initial evidence of anti-tumor activity in ccRCC has been observed, and tolerability supports continued dose escalation. Trial Schema The dosing period consists of priming, step-up, and target doses."

Clinical • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

Preliminary Phase 1 safety and antitumor activity of XmAb819, a first-in-class ENPP3 x CD3 bispecific antibody, in patients with advanced clear cell renal cell carcinoma (ccRCC) (AACR-NCI-EORTC 2025) - "XmAb819 is safe and well-tolerated at IV doses that induce antitumor activity in patients with advanced ccRCC. A recommended Phase 2 dose has not yet been determined. IV dose escalation continues."

Clinical • IO biomarker • Metastases • P1 data • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Solid Tumor

Wholly Owned Pipeline Overview: XmAb819 (Businesswire) - "Clear cell renal cell carcinoma (ccRCC): On track to initiate a registration enabling study of XmAb819 as a monotherapy in advanced ccRCC during 2027....A sub-study for patients with intermediate- or poor-risk advanced ccRCC who have progressed after nivolumab in combination with ipilimumab as a first-line treatment (IO doublet therapy) is planned to open for enrollment in the third quarter of 2026. A sub-study evaluating the combination of XmAb819 and anti-PD1 therapy in patients with advanced ccRCC is currently being planned....A sub-study for patients with ENPP3+ advanced colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma began enrollment in the second quarter of 2026."

Enrollment status • New trial • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Non Small Cell Lung Cancer • Papillary Renal Cell Carcinoma

XmAb819 Evaluation Across ENPP3+ Tumors (Businesswire) - "A sub-study for patients with ENPP3+ advanced colorectal cancer, non-small cell lung cancer and papillary renal cell carcinoma opened to enrollment in the second quarter of 2026, and A sub-study for patients with intermediate- or poor-risk advanced ccRCC who have progressed after nivolumab in combination with ipilimumab as a first-line treatment (IO doublet therapy) is planned to open to enrollment in the third quarter of 2026."

New trial • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Non Small Cell Lung Cancer • Papillary Renal Cell Carcinoma

Xencor Announces Proffered Paper Oral Presentation at ESMO 2026 for Phase 1 Clinical Study of XmAb819 in Advanced Clear Cell Renal Cell Carcinoma (Businesswire)

P1 data • Clear Cell Renal Cell Carcinoma

Wholly Owned Pipeline Overview: XmAb819 (ENPP3 x CD3) (Businesswire) - "(i) Xencor plans to present expansion cohort data from the ongoing Phase 1 study to define a recommended Phase 3 target dose at a medical conference in 2H26 and support initiation of a pivotal study of XmAb819 in ccRCC planned for 2027; (ii) Tumor expansion cohorts in ENPP3+ colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) are open to enrollment; (iii) Xencor plans to initiate a sub-study in patients with advanced ccRCC who have not previously received treatment with a tyrosine kinase inhibitor (TKI) in 3Q26."

New trial • P1 data • Trial status • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Non Small Cell Lung Cancer • Papillary Renal Cell Carcinoma

XmAb819-01: Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=307 | Recruiting | Sponsor: Xencor, Inc. | N=95 ➔ 307 | Trial completion date: Nov 2027 ➔ Dec 2028 | Trial primary completion date: Feb 2026 ➔ Feb 2027

Enrollment change • Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

XmAb819 (ENPP3 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC). (FinancialContent) - "We plan to: Present new clinical data to support a recommended Phase 3 dose in 2H26; Initiate tumor expansion cohorts in colorectal cancer (CRC), non-small cell lung cancer (NSCLC) and papillary renal cell carcinoma (pRCC) during 2026; Initiate a pivotal study of XmAb819 in ccRCC during 2027."

New trial • P1 data • Trial status • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Non Small Cell Lung Cancer • Papillary Renal Cell Carcinoma

XmAb819 (ENPP3 x CD3), a novel, first-in-class, tumor-targeted T-cell engaging XmAb 2+1 bispecific antibody in development for patients with advanced clear cell renal cell carcinoma (ccRCC) (Businesswire) - "The first dose-expansion cohort in the ongoing Phase 1 study is enrolling patients as dose-escalation continues. Xencor plans to select a recommended Phase 3 dose during 2026 to support initiation of a pivotal study in advanced ccRCC during 2027."

New P3 trial • Trial status • Clear Cell Renal Cell Carcinoma

XmAb819 (ENPP3 x CD3), a first-in-class, tumor-targeted, T-cell engaging 2+1 bispecific antibody in development for patients with clear cell renal cell carcinoma (ccRCC) (Businesswire) - "Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial dose-escalation data at a medical conference during the fourth quarter of 2025."

P1 data • Clear Cell Renal Cell Carcinoma

Xencor Presents Initial Data for XmAb819, a First-in-class ENPP3 x CD3 Bispecific T-Cell Engager, in Development for Clear Cell Renal Cell Carcinoma (Businesswire) - "The results were presented in a poster at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics....As of the September 19, 2025 data cut-off, 69 patients received XmAb819 across 10 intravenous (IV) dose cohorts and 5 subcutaneous (SC) dose cohorts....Of the 20 efficacy-evaluable patients treated at the dose levels that were preclinically predicted to be within the target dose range, 25% achieved a partial response (PR) as best response (n=5, 4 confirmed PRs and 1 unconfirmed PR), with a 70% disease control rate (DCR, 14/20)....Introduction of a low concentration formulation to be implemented during the first half of 2026."

P1 data • Trial status • Clear Cell Renal Cell Carcinoma

Xencor Announces Presentation of Initial Phase 1 Dose-Escalation Results of XmAb819 in Clear Cell Renal Cell Carcinoma at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics (Businesswire) - "Presentation of a dataset from an updated data-cut at the conference will include a detailed safety analysis along with efficacy results from the target dose range when the embargo lifts."

P1 data • Clear Cell Renal Cell Carcinoma

Xencor Reports Second Quarter 2025 Financial Results (Businesswire) - "Clinical Program Updates: Oncology:...(i) Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial dose-escalation data at a medical conference during the fourth quarter of 2025....; (ii) A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer, germ cell tumors, and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025."

P1 data • Trial status • Clear Cell Renal Cell Carcinoma • Germ Cell Tumors • Ovarian Cancer

XmAb819-01: Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Xencor, Inc. | Trial completion date: Mar 2027 ➔ Nov 2027 | Trial primary completion date: Apr 2025 ➔ Feb 2026

Trial completion date • Trial primary completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Clinical Program Updates and 2025 Priorities (Businesswire) - "Xencor is conducting a Phase 1 study to evaluate XmAb819 in patients with advanced ccRCC and plans to present initial data at a medical conference during the second half of 2025...The 2+1 multivalent format enables greater selectivity for targeting the tumor-associated antigen CLDN6 over similar Claudin family members, and new preclinical data demonstrating this selectivity were presented in January 2025. A Phase 1 dose-escalation study to evaluate XmAb541 in patients with ovarian cancer and other CLDN6-expressing tumor types is ongoing, with characterization of target dose levels anticipated to begin during 2025."

P1 data • Preclinical • Trial status • Clear Cell Renal Cell Carcinoma • Solid Tumor

Xencor Reports Third Quarter 2024 Financial Results (Businesswire) - P1 | N=95 | NCT05433142 | Sponsor: Xencor, Inc. | "Internal Clinical-Stage Program Updates:...XmAb819 (ENPP3 x CD3): In September 2024, Xencor announced that initial evidence of anti-tumor activity was observed in the ongoing Phase 1 dose-escalation study in patients with advanced clear cell renal cell carcinoma, including RECIST responses, and the duration of treatment for several patients in earlier dose cohorts had extended beyond one year. Cytokine release syndrome remained manageable, no maximum tolerated dose had been reached and the tolerability profile from recent dose cohorts supported continued dose escalation toward target dose levels. Xencor continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of the first dose expansion cohort during the first half of 2025."

Cytokine release syndrome • P1 data • Trial status • Clear Cell Renal Cell Carcinoma

XmAb819, a 2+1 bispecific antibody targeting ENPP3 X CD3 in development for RCC (DAVAGU 2024) - No abstract available.

Clinical Progress Updates in Early-Stage Oncology Programs: XmAb819 (ENPP3 x CD3) and XmAb808 (B7-H3 x CD28) (Businesswire) - "XmAb819: ENPP3 x CD3 bispecific T-cell engager in Phase 1 dose escalation for patients with advanced clear-cell renal cell carcinoma (ccRCC)....The Company continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of the first dose expansion cohort during the first half of 2025. XmAb808: B7-H3 x CD28 bispecific T-cell engager in Phase 1 dose escalation in advanced solid tumors....The Company continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of dose expansion cohorts during the first half of 2025."

P1 data • Trial status • Castration-Resistant Prostate Cancer • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

Xencor to Host Research & Development Webcast and Conference Call on Monday, September 9, 2024 (Businesswire) - "Xencor, Inc...announced that management will host a webcast and conference call at 8:00 a.m. ET (5:00 a.m. PT) on Monday, September 9, 2024 to introduce new XmAb programs in development for the treatment of patients with autoimmune diseases and to provide updates on continued progress in dose escalation with first-in-class oncology programs, including XmAb819 (ENPP3 x CD3) in patients with advanced clear cell renal cell carcinoma and XmAb808 (B7-H3 x CD28) in patients with advanced solid tumors."

Clinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor Reports Second Quarter 2024 Financial Results (Businesswire) - "Bispecific Antibody Programs Advancing in Internal Clinical Development: XmAb819 (ENPP3 x CD3):...Xencor is advancing through dose-escalation cohorts in an ongoing Phase 1 study, and the Company anticipates reaching target dose levels by year end; XmAb808 (B7-H3 x CD28):...Xencor is advancing through dose-escalation cohorts in an ongoing Phase 1 study, and the Company anticipates reaching target dose levels by year end."

Trial status • Clear Cell Renal Cell Carcinoma • Melanoma • Non Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck • Urothelial Cancer

Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma (clinicaltrials.gov) - P1 | N=95 | Recruiting | Sponsor: Xencor, Inc. | Trial completion date: Apr 2026 ➔ Mar 2027

Metastases • Trial completion date • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor Highlights 2023 Corporate Priorities and Provides Portfolio Updates (Businesswire) - "Plamotamab: Xencor plans to...Continue enrolling patients into the Phase 1 subcutaneous dose escalation study; Vudalima: Xencor plans to...Continue enrolling patients into the two Phase 2 clinical studies of vudalimab; XmAb104: Xencor plans to: Continue enrolling patients into the expansion portion of the Phase 1 clinical study; XmAb819: . Xencor plans to...Continue enrolling patients into the Phase 1 dose-escalation study in patients with RCC."

Enrollment status • Genito-urinary Cancer • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

A Phase 1, multiple-dose study to evaluate the safety and tolerability of XmAb819 (ENPP3 x CD3) in subjects with relapsed or refractory clear cell renal cell carcinoma (RCC) (SITC 2022) - P1 | "Research Sponsor: Xencor, Inc. Ethics Approval This study was approved wcg IRB; IRB Tracking Number 20221085."

Clinical • IO biomarker • P1 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Xencor to Present Seven Posters on Multiple Clinical Trials and Research-stage Programs at the SITC Annual Meeting (Businesswire) - "Xencor, Inc... today announced seven poster presentations at the 37th Annual Meeting of the Society for Immunotherapy of Cancer, being held in Boston, November 10-12, 2022....Data from the first patients enrolled in a Phase 2 study of vudalimab, Xencor’s selective PD-1 x CTLA-4 bispecific antibody, plus chemotherapy in patients with metastatic castration-resistant prostate cancer, will be presented in abstract 668."

P1 data • P2 data • Preclinical • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Kidney Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer