Phase 1/2 multiple ascending dose trial of the prostate-specific membrane antigen-targeted antibody drug conjugate MLN2704 in metastatic castration-resistant prostate cancer
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Background This phase 1/2 study evaluated the dose-limiting toxicity and maximum tolerated dose of MLN2704, a humanized monoclonal antibody MLN591 targeting prostate-specific membrane antigen, linked to the maytansinoid DM1 in patients with progressive metastatic castration-resistant prostate cancer.Patients and methods A total of 62 patients received MLN2704 at ascending doses on 4 schedules: weekly (60, 84, 118, and 165mg/m 2; 12 patients); every 2 weeks (120, 168, 236, and 330mg/m 2; 15 patients); every 3 weeks (330 and 426mg/m 2; 18 patients); and on days 1 and 15 of a 6-week schedule (6-week cycle, 330mg/m 2; 17 patients). The primary efficacy endpoint was a sustained ≥50% decline from baseline prostate-specific antigen (PSA) without evidence of disease progression. Toxicity, pharmacokinetics, immunogenicity, and antitumor activity were assessed.Results Neurotoxicity was dose-limiting. Overall, 44 patients (71%) exhibited peripheral neuropathy: 6 (10%) had grade 3/4. Neurotoxicity rates remained high despite increasing the dosing interval to 3 (13 of 14; one grade 3) and 6 weeks (16 of 17; three grade 3). MLN2704 pharmacokinetics were dose-linear. Rapid deconjugation of DM1 from the conjugated antibody was seen. In all, 5 patients (8%) experienced ≥50% decline in PSA; 5 (8%) had PSA stabilization lasting≥90 days. Only 2 of 35 patients on the 3- and 6-week schedules achieved a PSA decline of >50%.Conclusions MLN2704 has limited activity in metastatic castration-resistant prostate cancer. Disulfide linker lability and rapid deconjugation lead to neurotoxicity and a narrow therapeutic window.
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Disulfide linker lability and rapid deconjugation in MLN2704 led to significant neurotoxicity, with 44 (71%) patients experiencing dose-limiting peripheral neuropathy halting clinical development.
“Moreover, this trial found that disulfide linker lability and rapid deconjugation in MLN2704 led to significant neurotoxicity, with 44 (71%) patients experiencing dose-limiting peripheral neuropathy halting clinical development71.”
From The evolving landscape of antibody-drug conjugates (ADCs) for treatment of prostate cancer (2025) · cites this paper as [71]
The Abstract Results and Results > Adverse Events report peripheral neuropathy in 44 patients (71%), but only six (10%) had grade 3/4 neuropathy. The Abstract Conclusion links disulfide linker lability and rapid deconjugation to neurotoxicity, and the Discussion says the unfavorable safety profile precluded further study. The source calls neurotoxicity dose-limiting; it does not say that all 44 patients experienced dose-limiting neuropathy. (LLM, conf=0.89)
Experimental — accuracy not yet measuredIn a phase I/II trial, only 5 out of 62 patients with mCRPC (8%) had a decrease in PSA and PSA stabilization lasting ≥90 days following treatment, suggesting limited efficacy of MLN2704.
“This was then followed by a phase I/II trial in which only 5 out of 62 patients with mCRPC (8%) had a decrease in PSA and PSA stabilization lasting ≥90 days following treatment, suggesting limited efficacy of MLN270471.”
From The evolving landscape of antibody-drug conjugates (ADCs) for treatment of prostate cancer (2025) · cites this paper as [71]
The Results (Patient Characteristics; Antitumor Effects) report 62 patients, five (8%) with a ≥50% PSA decline, and five (8%) with PSA stabilization lasting ≥90 days. The Discussion describes overall efficacy as limited. The paper reports the decline and stabilization as separate outcomes; it does not establish that the same five patients had both. (LLM, conf=0.86)
Experimental — accuracy not yet measured
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Nathe, P., Singh, Y., Ratre, P., & Kulkarni, S. (2026) · Drug Discovery Today · doi:10.1016/j.drudis.2026.104750
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Zhao, J., Tang, B., Zeng, H., & Wei, Q. (2026) · Chinese Medical Journal · doi:10.1097/cm9.0000000000004322
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Ewart, I., & Randhawa, M. (2026) · Frontiers in Endocrinology · doi:10.3389/fendo.2026.1924299
- Authors
- Milowsky, M. I., Galsky, M. D., Morris, M. J., Crona, D. J., George, D. J., Dreicer, R., Tse, K., Petruck, J., Webb, I. J., Bander, N. H., Nanus, D. M., & Scher, H. I.
- Affiliations
- Memorial Sloan Kettering Cancer Center (US)
- University of North Carolina at Chapel Hill (US)
- Duke Medical Center (US)
- Cleveland Clinic (US)
- Takeda Oncology (United States) (US)
- Weill Cornell Medicine (US)
- Corresponding author
- Scher, Howard I.
- ORCID
- Venue
- Urologic Oncology: Seminars and Original Investigations
- Publisher
- Elsevier BV
- Published
- 2016-12
- Volume
- 34
- Issue
- 12
- Pages
- 530.e15-530.e21
- ISSN
- 1078-1439 (ISSN-L)
- PMC
- PMC5464417
- OpenAlex
- W2539038764
- Cited by
- 78
- References
- 12
- Citations by year
- 2026: 7 · 2025: 16 · 2024: 11 · 2023: 10 · 2022: 7 · 2021: 13 · 2020: 4 · 2019: 3 · 2018: 5 · 2017: 2
- FWCI
- 2.98
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Urologic Oncology Seminars and Original Investigations (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Cancer Institute (P30CA008748, P30CA016086)
- Topics
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Treatment and Research
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Prostate Cancer Diagnosis and Treatment
- Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Monoclonal and Polyclonal Antibodies Research
- Keywords
- antibody-drug conjugates, prostate-specific membrane antigen, metastatic castration-resistant prostate cancer, maytansinoid DM1, dose-limiting toxicity, peripheral neuropathy, neurotoxicity, pharmacokinetics, deconjugation, dosing regimen, PSA response, immunogenicity
- MeSH terms
- Antineoplastic Agents, Immunological, Adenocarcinoma, Aged, Aged, 80 and over, Antibodies, Monoclonal, Dose-Response Relationship, Immunologic, Gastrointestinal Diseases, Humans, Male, Maytansine, Middle Aged, Peripheral Nervous System Diseases, Drug Monitoring, Prostate-Specific Antigen, Disease-Free Survival, Immunoconjugates, Maximum Tolerated Dose, Prostatic Neoplasms, Castration-Resistant
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