XmAb808 / Xencor - LARVOL DELTA

XmAb808-01: Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Xencor, Inc. | Active, not recruiting ➔ Completed

Trial completion • Breast Cancer • Castration-Resistant Prostate Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Eye Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hormone Receptor Positive Breast Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uveal Melanoma

XmAb808-01: Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Xencor, Inc. | Recruiting ➔ Active, not recruiting | N=220 ➔ 60 | Trial completion date: Dec 2027 ➔ Jun 2025 | Trial primary completion date: Dec 2027 ➔ Jun 2025

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • Castration-Resistant Prostate Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Eye Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Adenocarcinoma • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uveal Melanoma

Clinical Program Updates and 2025 Priorities (Businesswire) - "XmAb808 (B7-H3 x CD28), a bispecific antibody to provide conditional co-stimulation of T cells when also bound to tumor cells. Dose escalation in an ongoing Phase 1 study combining XmAb808 with pembrolizumab resumed late in the fourth quarter of 2024, and enrollment in the final dose-escalation cohort is complete. To date a maximum tolerated dose has not been reached, and data from the study are expected to inform future development decisions for the program. Xencor does not plan to initiate expansion cohorts in combination with pembrolizumab. Potential combination with CD3 T-cell engaging bispecific antibodies is being evaluated."

Trial status • Solid Tumor

Xencor Reports Third Quarter 2024 Financial Results (Businesswire) - P1 | N=220 | NCT05585034 | Sponsor: Xencor, Inc. | "XmAb808 (B7-H3 x CD28): In the ongoing Phase 1 study’s highest dose cohort to date...two patients experienced dose-limiting toxicities as defined in the study protocol. One patient experienced an infusion-related reaction during administration of the first dose of XmAb808. A second patient experienced immune-related hepatitis with Grade 4 elevation of transaminases and Grade 3 elevation of bilirubin....Xencor anticipates that dose escalation will continue per protocol if the currently enrolling cohort continues to be tolerable....Xencor announced that most patients enrolled into the Phase 1 dose-escalation study were men with...mCRPC, and in this group, prostate specific antigen (PSA) declines had been observed during the four-week monotherapy safety run-in period. Xencor 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

A B7-H3-targeted CD28 bispecific antibody enhances the activity of anti-PD1 and CD3 T-cell engager immunotherapies. (PubMed, Mol Cancer Ther) - "XmAb808 as monotherapy and in combination with an anti-PD1 antibody is currently in clinical development in patients with advanced solid tumors. Our results suggest that XmAb808 may also combine with tumor antigen-targeted anti-CD3 (Signal 1) T-cell engagers."

IO biomarker • Journal • Breast Cancer • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor • BCL2L1 • CD276 • CD28 • IFNG • IL2 • IL2RA

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

Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Xencor, Inc.

Combination therapy • Metastases • Trial completion date • Trial primary completion date • Breast Cancer • Castration-Resistant Prostate Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Eye Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uveal Melanoma

A phase 1, first-in-human (FIH), open-label, dose-finding and expansion study of XmAb808, a B7H3 x CD28 bispecific antibody, in combination with pembrolizumab in patients with advanced solid tumors (SITC 2023) - "Exploratory objectives include analysis of intratumoral and peripheral PD, including markers of T-cell activation; expression of tumor/immune markers; ctDNA levels; and association of PK and/or PD with clinical outcome. Enrollment has begun."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Genito-urinary Cancer • Head and Neck Cancer • Melanoma • Oncology • Prostate Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • CD276 • CD28

Xencor to Present Multiple Posters at the SITC Annual Meeting (Businesswire) - "Xencor, Inc...today announced three poster presentations at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC), being held in San Diego, November 1-5, 2023."

Clinical data • P1 data • Oncology • Solid Tumor

Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmAb®808 in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Xencor, Inc. | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Eye Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uveal Melanoma

Phase 1, First-in-human, Dose-finding and Expansion Study to Evaluate XmA®b808 in Combination With Pembrolizumab in Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=220 | Not yet recruiting | Sponsor: Xencor, Inc.

Combination therapy • New P1 trial • Breast Cancer • Clear Cell Renal Cell Carcinoma • Colorectal Cancer • Eye Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Head and Neck Cancer • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • Urothelial Cancer • Uveal Melanoma

Xencor Highlights 2022 Corporate Priorities and Portfolio Milestones (Businesswire) - "Expand the Company’s portfolio with the first internally developed XmAb® 2+1 CD3 and XmAb® CD28 bispecific antibodies advancing into Phase 1 clinical studies; XmAb819 (ENPP3 x CD3)...Initiate a Phase 1 study evaluating XmAb819 in patients with RCC in the first half of 2022. XmAb808 (B7-H3 x CD28)...Submit an IND application in the first half of 2022, and initiate a Phase 1 study in patients with advanced solid tumors in the second half of 2022."

IND • New P1 trial • Oncology • Renal Cell Carcinoma • Solid Tumor