ArticleClinical cancer research : an official journal of the American Association for Cancer Research2024
A Phase I Study of Acapatamab, a Half-life Extended, PSMA-Targeting Bispecific T-cell Engager for Metastatic Castration-Resistant Prostate Cancer.
Article in Clinical cancer research : an official journal of the American Association for Cancer Research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03792841 (A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager Acapatamab in Subjects With Metastatic Castration-resistant Prostate Cancer), which is not on this map. Cited by 53 papers, 2 of them syntheses that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 1 Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Prostate Specific Membrane Antigen Half-life Extended Bispecific T-cell Engager Acapatamab in Subjects With Metastatic Castration-resistant Prostate Cancer
Who cites it
53 citing papers in PubMed, 2 syntheses or guidelines pooled it, 48 citations in OpenAlex.
- Immunotherapeutic strategies for castration-resistant prostate cancer: A systematic review of mechanisms, clinical advances and emerging approaches.Molecular biology reports · 2026Pooled it
- Novel Therapeutic Strategies for Metastatic Prostate Cancer Care.European urology · 2025Pooled it
- Tumor‑immune spatiotemporal co‑evolution: A new paradigm for understanding and overcoming therapy resistance in metastatic castration‑resistant prostate cancer (Review).International journal of molecular medicine · 2026Review
- Novel immunotherapies for prostate cancer.Urologic oncology · 2026Review
- Ineffectiveness of immune checkpoint inhibitors in prostate cancer: is it just a question of '-mabs'?The Journal of pathology · 2026Review
- uPAR-Targeting T Cell Engager Exerts Senolytic Effects in Mice and Non-Human Primates With Serum Aminotransferase Activity as a Safety Monitor.Aging cell · 2026Article
- PLP1-triggered NOT gate to address neurotoxicity risk of PSMA-targeted prostate cancer therapy.Journal for immunotherapy of cancer · 2026Article
- 177 Lu-PSMA for prostate cancer: progress, challenges and future perspectives.Asian journal of andrology · 2026Review
- Stem Cell-Delivered Cytosine Deaminase/5-Fluorocytosine and TRAIL Gene Therapy for Castration-Resistant Prostate Cancer: Translational Synthesis and First-in-Human Trial Concept.International journal of molecular sciences · 2026Review
- Advances in cancer immunotherapy: adoptive cell therapy and immune cell engagers in solid tumours.British journal of cancer · 2026Review
- Novel therapeutic strategies for metastatic castration‑resistant prostate cancer: Beyond androgen receptor pathway inhibition (Review).International journal of oncology · 2026Review
- Landscape of T-cell bispecific antibodies in cancer therapy: therapeutic strategies, challenges and future prospection.Molecular cancer · 2026Review
- Prevalence of adverse events following T-cell redirecting therapies in patients with metastatic castration-resistant prostate cancer: a pooled analysis.The oncologist · 2026Article
- Landscape of T-cell engagers in solid tumors.The oncologist · 2026Review
- Association of Prior PARP Inhibitor Exposure with Clinical Outcomes afterEuropean urology oncology · 2026Article
- Ready or not, here they come: a practical guide to adoptive T-cell therapies for solid tumors for medical oncologists.The oncologist · 2026Review
- Novel Immunotherapeutic Strategies for Castration-Resistant Prostate Cancer: Mechanisms and Clinical Advances.Current issues in molecular biology · 2026Review
- The path forward for T cell engagers in patients with prostate cancer.Journal for immunotherapy of cancer · 2026Review
- Focusing on Prostate-Specific Membrane Antigen in Precision Diagnosis and Treatment of Prostate Cancer.Biomedicines · 2026Review
- Recurrent Immunogenic Neoantigens and Their Cognate T-cell Receptors in Treatment-Resistant Metastatic Prostate Cancer.Cancer discovery · 2026Article
Corrections and comments
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Authors and funding
28 authors at 18 institutions in 8 countries.
Funding
Abstract
purposeSafety and efficacy of acapatamab, a prostate-specific membrane antigen (PSMA) x CD3 bispecific T-cell engager were evaluated in a first-in-human study in metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND
methodsPatients with mCRPC refractory to androgen receptor pathway inhibitor therapy and taxane-based chemotherapy received target acapatamab doses ranging from 0.003 to 0.9 mg in dose exploration (seven dose levels) and 0.3 mg (recommended phase II dose) in dose expansion intravenously every 2 weeks. Safety (primary objective), pharmacokinetics, and antitumor activity (secondary objectives) were assessed.
resultsIn all, 133 patients (dose exploration, n = 77; dose expansion, n = 56) received acapatamab. Cytokine release syndrome (CRS) was the most common treatment-emergent adverse event seen in 97.4% and 98.2% of patients in dose exploration and dose expansion, respectively; grade ≥ 3 was seen in 23.4% and 16.1%, respectively. Most CRS events were seen in treatment cycle 1; incidence and severity decreased at/beyond cycle 2. In dose expansion, confirmed prostate-specific antigen (PSA) responses (PSA50) were seen in 30.4% of patients and radiographic partial responses in 7.4% (Response Evaluation Criteria in Solid Tumors 1.1). Median PSA progression-free survival (PFS) was 3.3 months [95% confidence interval (CI): 3.0-4.9], radiographic PFS per Prostate Cancer Clinical Trials Working Group 3 was 3.7 months (95% CI: 2.0-5.4). Acapatamab induced T-cell activation and increased cytokine production several-fold within 24 hours of initiation. Treatment-emergent antidrug antibodies were detected in 55% and impacted serum exposures in 36% of patients in dose expansion.
conclusionsAcapatamab was safe and tolerated and had a manageable CRS profile. Preliminary signs of efficacy with limited durable antitumor activity were observed. Acapatamab demonstrated pharmacokinetic and pharmacodynamic activity.
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