Phase 1/2 multiple ascending dose trial of the prostate-specific membrane antigen-targeted antibody drug conjugate MLN2704 in metastatic castration-resistant prostate cancer

Urologic Oncology: Seminars and Original Investigations

Volumn 34, Issue 12, 2016, Pages 530.e15-530.e21

  Milowsky, Matthew I ^a,b,g   Galsky, Matthew D ^a,b,h   Morris, Michael J ^a,b   Crona, Daniel J ^c   George, Daniel J ^d   Dreicer, Robert ^e,i   Tse, Kin ^a   Petruck, Jesika ^f   Webb, Iain J ^f   Bander, Neil H ^a,b   Nanus, David M ^b   Scher, Howard I ^a,b  

^a MEMORIAL SLOAN KETTERING CANCER CENTER   (United States)

^b WEILL CORNELL MEDICAL COLLEGE   (United States)

^c UNC Hamner Institute for Drug Safety Sciences   (United States)

^d DUKE UNIVERSITY MEDICAL CENTER   (United States)

^e TAUSSIG CANCER INSTITUTE   (United States)

^f MILLENNIUM PHARMACEUTICALS INC   (United States)

^g UNIVERSITY OF NORTH CAROLINA   (United States)

^h MOUNT SINAI SCHOOL OF MEDICINE   (United States)

ⁱ UNIVERSITY OF VIRGINIA   (United States)

Author keywords

Castration resistant prostate cancer; DM1; Maytansinoid; MLN2704; Multiple ascending dose; PSMA

Indexed keywords

ALANINE AMINOTRANSFERASE; ANTINEOPLASTIC AGENT; ASPARTATE AMINOTRANSFERASE; MLN 2704; MONOCLONAL ANTIBODY; PROSTATE SPECIFIC ANTIGEN; UNCLASSIFIED DRUG; ANTIBODY CONJUGATE; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; MAYTANSINE; MLN2704 ANTIBODY;

ADULT; AGED; ALANINE AMINOTRANSFERASE BLOOD LEVEL; ANOREXIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTICLE; ASPARTATE AMINOTRANSFERASE BLOOD LEVEL; BODY WEIGHT DISORDER; BONE PAIN; CANCER CHEMOTHERAPY; CASTRATION RESISTANT PROSTATE CANCER; CONSTIPATION; DIARRHEA; DRUG CLEARANCE; DRUG EFFICACY; DRUG HALF LIFE; DRUG WITHDRAWAL; FATIGUE; FEVER; HUMAN; IMMUNOGENICITY; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTIPLE CYCLE TREATMENT; MUSCULOSKELETAL PAIN; NAUSEA; NEUROTOXICITY; PERIPHERAL NEUROPATHY; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; RIGOR; SIDE EFFECT; VOMITING; ADENOCARCINOMA; BLOOD; CHEMICALLY INDUCED; CLINICAL TRIAL; COMPARATIVE STUDY; DISEASE FREE SURVIVAL; DOSE RESPONSE; DRUG MONITORING; GASTROINTESTINAL DISEASE; MAXIMUM TOLERATED DOSE; MIDDLE AGED; SECONDARY; VERY ELDERLY;

ADENOCARCINOMA; AGED; AGED, 80 AND OVER; ANTINEOPLASTIC AGENTS, IMMUNOLOGICAL; DISEASE-FREE SURVIVAL; DOSE-RESPONSE RELATIONSHIP, IMMUNOLOGIC; DRUG MONITORING; GASTROINTESTINAL DISEASES; HUMANS; IMMUNOCONJUGATES; MALE; MAXIMUM TOLERATED DOSE; MAYTANSINE; MIDDLE AGED; PERIPHERAL NERVOUS SYSTEM DISEASES; PROSTATE-SPECIFIC ANTIGEN; PROSTATIC NEOPLASMS, CASTRATION-RESISTANT;

EID: 84997076993     PISSN: 10781439     EISSN: 18732496     Source Type: Journal    
DOI: 10.1016/j.urolonc.2016.07.005     Document Type: Article

References (12)

1. [1] Tagawa, S.T., Beltran, H., Vallabhajosula, S., et al. Anti-prostate-specific membrane antigen-based radioimmunotherapy for prostate cancer. Cancer 116 (2010), 1075–1083.
2. [2] Galsky, M.D., Eisenberger, M., Moore-Cooper, S., et al. Phase I trial of the prostate-specific membrane antigen-directed immunoconjugate MLN2704 in patients with progressive metastatic castration-resistant prostate cancer. J Clin Oncol 26 (2008), 2147–2154.
3. [3] Calhoun, E.A., Welshman, E.E., Chang, C.H., et al. Psychometric evaluation of the Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (Fact/GOG-Ntx) questionnaire for patients receiving systemic chemotherapy. Int J Gynecol Cancer 13 (2003), 741–748.
4. [4] Tolcher, A.W., Ochoa, L., Hammond, L.A., et al. Cantuzumab mertansine, a maytansinoid immunoconjugate directed to the CanAg antigen: a phase I, pharmacokinetic, and biologic correlative study. J Clin Oncol 21 (2003), 211–222.
5. [5] Kellogg, B.A., Garrett, L., Kovtun, Y., et al. Disulfide-linked antibody-maytansinoid conjugates: optimization of in vivo activity by varying the steric hindrance at carbon atoms adjacent to the disulfide linkage. Bioconjug Chem 22 (2011), 717–727.
6. [6] Krop, I.E., Beeram, M., Modi, S., et al. Phase I study of trastuzumab-DM1, an HER2 antibody-drug conjugate, given every 3 weeks to patients with HER2-positive metastatic breast cancer. J Clin Oncol 28 (2010), 2698–2704.
7. [7] Burris, H.A. 3rd, Rugo, H.S., Vukelja, S.J., et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2)-positive breast cancer after prior HER2-directed therapy. J Clin Oncol 29 (2011), 398–405.
8. [8] Henry, M.D., Wen, S., Silva, M.D., Chandra, S., Milton, M., Worland, P.J., A prostate-specific membrane antigen-targeted monoclonal antibody-chemotherapeutic conjugate designed for the treatment of prostate cancer. Cancer Res 64 (2004), 7995–8001.
9. 177Lu-DOTAhuJ591 anti prostate specific membrane antigen specific monoclonal antibody. Curr Radiopharm 9 (2016), 44–53.
10. [10] Kratochwil, C., Giesel, F.L., Stefanova, M., et al. PSMA-targeted radionuclide therapy of metastatic castration-resistant prostate cancer with Lu-177 labeled PSMA-617. J Nucl Med, 115, 2016, 171397.
11. 177Lu-PSMA-DKFZ-617 in patients with metastatic castration-resistant prostate cancer: a multicenter retrospective analysis. J Nucl Med, 116, 2016, 173757.
12. 177Lu-labeled prostate-specific membrane antigen radioligand therapy of metastatic castration-resistant prostate cancer: safety and efficacy. J Nucl Med, 115, 2016, 168443.