A Study of the Safety and Pharmacokinetics of Escalating Doses of DSTP3086S in Patients With Metastatic Castration-Resistant Prostate Cancer

NCT01283373 | Completed Phase 1

• 2 other identifiers: DST4964gGO00768
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 5

Brief Summary

This is a Phase I, multicenter, open-label, dose-escalation study of DSTP3086S administered as a single agent by intravenous (IV) infusion to patients with metastatic Castration-Resistant Prostate Cancer (CRPC).

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Incidence and nature of dose-limiting toxicities (DLTs)

  Days 1-21

Secondary Outcomes (5)

• Area under the concentration-time curve

  Up to 1 year

• Maximum and minimum concentrations

  Up to 1 year

• Clearance

  Up to 1 year

• Half-life

  Up to 1 year

• Volume of distribution

  Up to 1 year

Study Arms (2)

A

EXPERIMENTAL

Dose escalation cohorts

Drug: DSTP3086S

B

EXPERIMENTAL

Dose expansion cohorts

Drug: DSTP3086S

Interventions

DSTP3086S DRUG

DSTP3086S administered intravenously

B

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Life expectancy of at least 12 weeks
• Histologic documentation of adenocarcinoma of the prostate
• Surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone
• Metastatic progressive CRPC defined as progressive disease despite surgical castration or ongoing use of gonadotropin-releasing hormone agonists with confirmed castrate levels of testosterone
• For patients in the dose-expansion cohort of the study, not more than two prior lines of cytotoxic chemotherapy in the metastatic setting
• Evaluable or measurable disease
• Documented willingness to use an effective means of contraception

You may not qualify if:

• Anti-tumor therapy, including chemotherapy, biologic, experimental, or hormonal therapy, or radiotherapy within 4 weeks prior to Day 1, with the following exceptions: maintenance hormonal therapy for metastatic prostate cancer and palliative radiation to bone metastases within 2 weeks prior to Day 1
• Major surgical procedure within 4 weeks prior to Day 1
• Known active bacterial, viral, fungal, mycobacterial, or other infection (including HIV and atypical mycobacterial disease, but excluding fungal infections of the nail beds)
• Ongoing corticosteroid use with \> 10 mg of daily prednisone or equivalent
• Symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. Patients who are receiving bisphosphonate therapy specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.
• History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)
• Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
• Untreated or active central nervous system (CNS) metastases. Patients with a history of treated CNS metastases are eligible, provided that they meet all of the following criteria: evaluable or measurable disease outside the CNS, radiographic demonstration of improvement upon the completion of CNS-directed therapy and no evidence of interim progression between the completion of CNS-directed therapy and the screening radiographic study, and screening CNS radiographic study is \>/= 8 weeks since completion of radiotherapy and \>/= 4 weeks since the discontinuation of corticosteroids and anticonvulsants
• Dose expansion cohort (B): no prior chemotherapy is allowed

Sponsors & Collaborators

• Genentech, Inc.: lead

Study Sites (5)

Unknown Facility

San Francisco, California, 94115, United States

Location

Unknown Facility

Chicago, Illinois, 60637, United States

Location

Unknown Facility

Detroit, Michigan, 48201, United States

Location

Unknown Facility

New York, New York, 10065, United States

Location

Unknown Facility

Seattle, Washington, 98195, United States

Location

Related Publications (2)

• Martiniova L, Zielinski RJ, Lin M, DePalatis L, Ravizzini GC. The Role of Radiolabeled Monoclonal Antibodies in Cancer Imaging and ADC Treatment. Cancer J. 2022 Nov-Dec 01;28(6):446-453. doi: 10.1097/PPO.0000000000000625.

  PMID: 36383907 DERIVED

• Danila DC, Szmulewitz RZ, Vaishampayan U, Higano CS, Baron AD, Gilbert HN, Brunstein F, Milojic-Blair M, Wang B, Kabbarah O, Mamounas M, Fine BM, Maslyar DJ, Ungewickell A, Scher HI. Phase I Study of DSTP3086S, an Antibody-Drug Conjugate Targeting Six-Transmembrane Epithelial Antigen of Prostate 1, in Metastatic Castration-Resistant Prostate Cancer. J Clin Oncol. 2019 Dec 20;37(36):3518-3527. doi: 10.1200/JCO.19.00646. Epub 2019 Nov 5.

  PMID: 31689155 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Bernard Fine, M.D.

  Genentech, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2011
• First Posted: January 26, 2011
• Study Start: March 1, 2011
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

US (5)