ABBV-969 / AbbVie - LARVOL DELTA

Baseline molecular characterization and responses associated with ABBV-969 treatment in patients with metastatic castration-resistant prostate cancer (ESMO 2026) - No abstract available

Clinical • Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

A phase 1, first-in-human (FIH) study evaluating the safety, pharmacokinetics, and efficacy of ABBV-969 in patients with metastatic castration-resistant prostate cancer (mCRPC). (ASCO 2026) - P1 | "ABBV-969 demonstrated promising antitumor activity and a manageable safety profile in heavily pretreated pts with mCRPC. Dose optimization is ongoing. Pt demographics and safety."

Clinical • First-in-human • Metastases • P1 data • PK/PD data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Pneumonia • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • STEAP1

A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=152 | Active, not recruiting | Sponsor: AbbVie | Recruiting ➔ Active, not recruiting | N=230 ➔ 152

Adverse events • Enrollment change • Enrollment closed • First-in-human • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

City of Hope Researchers to Share New Immunotherapy and Precision Medicine Insights Across Cancer Types at ASCO 2026 (City of Hope)

Clinical data • Castration-Resistant Prostate Cancer • Hepatocellular Cancer • Large B Cell Lymphoma • Pancreatic Cancer • Renal Cell Carcinoma

AbbVie Announces New Data at ASCO 2026 Demonstrating Breadth and Momentum Across its Next-Generation Oncology Pipeline (AbbVie Press Release)

P1 data • Platinum resistant • Castration-Resistant Prostate Cancer • Multiple Myeloma • Ovarian Cancer • Small Cell Lung Cancer • Squamous Cell Carcinoma of Head and Neck

ABBV-969: A first-in-class dual-targeting PSMA-STEAP1 drug conjugate for the treatment of metastatic castrate-resistant prostate cancer (AACR 2025) - P1 | "ABBV-969 is a conjugate of the DVD-Ig with a proprietary topoisomerase-1 (Top1) inhibitor linker-drug identical to that used in two assets in clinical development, ABBV-400, targeting c-Met, and ABBV-706, targeting SEZ6. Furthermore, ABBV-969 is well tolerated in cynomolgus monkeys with bone marrow and gastrointestinal toxicities common to other Top1 inhibitor ADCs. ABBV-969 is currently in dose escalation in a Phase 1 clinical study (NCT06318273)."

Metastases • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • FOLH1 • MET • SEZ6 • STEAP1 • TOP1

A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=230 | Recruiting | Sponsor: AbbVie | N=36 ➔ 230

Adverse events • Enrollment change • First-in-human • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor

ABBV-969: Data readout from P1 trial (NCT06318273) for mCRPC in 2026 (AbbVie) - Q4 2025 Results

P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer

STEAP1-targeted strategies in advanced prostate cancer: a review on therapeutic and diagnostic implications. (PubMed, Prostate Cancer Prostatic Dis) - "STEAP1 represents a promising diagnostic and therapeutic target in prostate cancer, and its potential role in shaping future management of the disease warrants continued investigation."

Journal • Review • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • STEAP1

STEAP1-targeted strategies in advanced prostate cancer: a review on therapeutic and diagnostic implications (Nature) - "This review discusses STEAP1-based diagnostics, including molecular imaging (89Zr-DFO-MSTP2109A) and liquid biopsy methods, as well as therapeutics, such as STEAP1 antibodies, antibody-drug conjugates (DSPT3086S, ADRX-0405, ABBV-969, and DXC008), chimeric antigen receptor T-cell therapy (STEAP1 CAR-T), bispecific T-cell engagers (Xaluritamig/AMG 509, BC261), and cancer vaccines....STEAP1 represents a promising diagnostic and therapeutic target in prostate cancer, and its potential role in shaping future management of the disease warrants continued investigation."

Review • Prostate Cancer

Recent advances in antibody-drug conjugates for metastatic castration-resistant prostate cancer. (PubMed, Zhejiang Da Xue Xue Bao Yi Xue Ban) - P3 | "Among prostate-specific membrane antigen (PSMA)-targeted ADCs, ARX517 demonstrates superior safety and more significant prostate-specific antigen (PSA) reductions compared to earlier agents such as MLN2704, PSMA-ADC, and MEDI3726. ADCs targeting B7-H3, such as MGC018 and DB-1311, have also shown antitumor activity. ADCs targeting other antigens, including six-transmembrane epithelial antigen of the prostate (STEAP)1 (DSTP3086S), trophoblast cell surface antigen (TROP)2 (sacituzumab govitecan), and solute carrier (SLC) 44A4 (ASG-5ME), have shown preliminary antitumor activity in early trials but face challenges with insufficient efficacy or toxicity. Tisotumab vedotin (targeting tissue factor) has shown no significant therapeutic response in mCRPC. Meanwhile, disitamab vedotin (HER2-targeted), ABBV-969 (dual PSMA/STEAP1-targeted), and DXC008 (dual PSMA/STEAP1-targeted) are currently under evaluation. Notably, the B7-H3-targeted ADC ifinatamab deruxtecan has initiated..."

Journal • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • HER-2 • SLC44A4 • SLC4A4 • STEAP1

Phase 1, open-label, first-in-human study of ABBV-969, a dual variable antibody-drug conjugate, in patients with metastatic castration-resistant prostate cancer. (ASCO 2025) - P1 | "Urology 1998; 52:637–40. Objectives and endpoints.Previously presented at ESMO 2024, FPN: 1660TiP, Raanan Berger et al - reused with permission."

Clinical • Metastases • P1 data • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • Urology • STEAP1

AbbVie Features New Data Across Difficult-to-Treat Solid Tumors and Blood Cancers at ASCO 2025, Highlighting Breadth and Depth of its Oncology Portfolio (PRNewswire) - "AbbVie...announced that key data from its broad oncology portfolio will be showcased across multiple oral presentations and posters at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025). These new data highlight significant progress in AbbVie's robust oncology pipeline, across a range of difficult-to-treat solid tumors and blood cancers."

Clinical data • B Cell Non-Hodgkin Lymphoma • Castration-Resistant Prostate Cancer • Prostate Cancer • Urothelial Cancer

AbbVie Showcases Early Pipeline and Scientific Advances in Oncology at AACR Annual Meeting 2025 (PRNewswire) - "Data for ABBV-969, a novel STEAP1/PSMA dual-targeted antibody-drug conjugate (ADC) in Phase 1 for advanced prostate cancer, will be presented in an oral presentation; Data to be presented on ABBV-514, a novel CCR8 targeting antibody, in Phase 1 for non-small cell lung cancer, head and neck cancer and other solid tumors."

P1 data • Prostate Cancer • Squamous Cell Carcinoma of Head and Neck

First-in-human study of ABBV-969, a dual variable antibody-drug conjugate (ADC), in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (ESMO 2024) - P1 | "Pts will be enrolled in US, Israel, Japan, and Australia in part 1; additional locations may be added. Table: 1660TiP"

Clinical • Metastases • P1 data • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor • STEAP1

A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: AbbVie

Adverse events • Metastases • New P1 trial • Genito-urinary Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor