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History of Changes for Study: NCT02376699
Safety Study of SEA-CD40 in Cancer Patients
Latest version (submitted May 18, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 25, 2015 None (earliest Version on record)
2 March 19, 2015 Study Status and Contacts/Locations
3 March 31, 2015 Study Status
4 April 28, 2015 Study Status and Contacts/Locations
5 May 28, 2015 Contacts/Locations and Study Status
6 June 30, 2015 Contacts/Locations and Study Status
7 July 31, 2015 Contacts/Locations and Study Status
8 August 28, 2015 Study Status
9 September 29, 2015 Contacts/Locations and Study Status
10 October 28, 2015 Contacts/Locations and Study Status
11 November 30, 2015 Study Status
12 December 23, 2015 Contacts/Locations and Study Status
13 January 28, 2016 Study Status
14 February 25, 2016 Study Status and Conditions
15 March 17, 2016 Arms and Interventions, Study Design, Conditions, Study Status, Eligibility and Study Description
16 March 23, 2016 Study Status, Contacts/Locations, Eligibility and Conditions
17 March 28, 2016 Study Status
18 April 29, 2016 Study Status
19 July 15, 2016 Conditions, Eligibility, Outcome Measures and Study Status
20 July 20, 2016 Study Status, Contacts/Locations and Conditions
21 August 29, 2016 Study Status
22 September 28, 2016 Contacts/Locations and Study Status
23 October 28, 2016 Study Status
24 November 30, 2016 Study Status
25 January 23, 2017 Study Status, Arms and Interventions, Study Description, Outcome Measures and Study Design
26 January 27, 2017 Contacts/Locations and Study Status
27 February 27, 2017 Study Status
28 March 30, 2017 Study Status and Contacts/Locations
29 May 11, 2017 Arms and Interventions, Conditions, Study Description, Study Status, Contacts/Locations, Eligibility and Study Design
30 May 30, 2017 Contacts/Locations, Arms and Interventions, Eligibility, Conditions and Study Status
31 June 28, 2017 Study Status
32 July 28, 2017 Study Status and Contacts/Locations
33 September 1, 2017 Study Status and Contacts/Locations
34 September 28, 2017 Contacts/Locations and Study Status
35 October 30, 2017 Study Status and Contacts/Locations
36 November 29, 2017 Contacts/Locations and Study Status
37 December 21, 2017 Study Status and Contacts/Locations
38 January 30, 2018 Study Status
39 March 12, 2018 Arms and Interventions, Study Status, Contacts/Locations, Study Description, Eligibility and Study Design
40 March 30, 2018 Study Status and Contacts/Locations
41 April 30, 2018 Study Status
42 May 31, 2018 Study Status and Contacts/Locations
43 June 21, 2018 Study Status, Contacts/Locations, Eligibility, Arms and Interventions, Study Design, Study Description, Sponsor/Collaborators and Study Identification
44 June 29, 2018 Study Status
45 August 1, 2018 Contacts/Locations and Study Status
46 August 31, 2018 Study Status
47 October 17, 2018 Contacts/Locations and Study Status
48 October 31, 2018 Study Status
49 December 21, 2018 Recruitment Status, Study Status, Contacts/Locations and Study Design
50 September 6, 2019 Recruitment Status, Outcome Measures, Arms and Interventions, Study Status, Contacts/Locations, Study Design, Study Description, Eligibility and Conditions
51 September 30, 2019 Contacts/Locations and Study Status
52 October 31, 2019 Study Status and Contacts/Locations
53 November 30, 2019 Study Status and Contacts/Locations
54 January 15, 2020 Contacts/Locations and Study Status
55 February 25, 2020 Study Status and Contacts/Locations
56 April 25, 2020 Study Status and Contacts/Locations
57 May 31, 2020 Contacts/Locations and Study Status
58 July 7, 2020 Study Status
59 August 1, 2020 Study Status and Contacts/Locations
60 October 13, 2020 Study Status, Contacts/Locations and Study Design
61 December 7, 2020 Study Status, Contacts/Locations and Conditions
62 March 12, 2021 Recruitment Status, Study Status, Contacts/Locations, Study Design and Conditions
63 September 17, 2021 Study Status and Contacts/Locations
64 December 3, 2021 Study Status
65 December 10, 2021 Contacts/Locations and Study Status
66 January 21, 2022 Study Status
67 February 1, 2022 Study Status
68 May 18, 2022 Study Status
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Study NCT02376699
Submitted Date:  February 25, 2015 (v1)

Open or close this module Study Identification
Unique Protocol ID: SGNS40-001
Brief Title: Safety Study of SEA-CD40 in Cancer Patients
Official Title: A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2015
Overall Status: Recruiting
Study Start: February 2015
Primary Completion: January 2018 [Anticipated]
Study Completion: March 2019 [Anticipated]
First Submitted: February 17, 2015
First Submitted that
Met QC Criteria:
February 25, 2015
First Posted: March 3, 2015 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 25, 2015
Last Update Posted: March 3, 2015 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Seagen Inc.
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: This study will examine the safety profile of SEA-CD40. The study will test increasing doses of SEA-CD40 given at least every 3 weeks to small groups of patients. The goal is to find the highest dose of SEA-CD40 that can be given to patients that does not cause unacceptable side effects. The pharmacokinetics, pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also be evaluated.
Detailed Description:
Open or close this module Conditions
Conditions: Cancer
Carcinoma
Neoplasms
Neoplasm Metastasis
Keywords: CD40 Antigen
Drug Therapy
Immunotherapy
Monoclonal Antibody
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 144 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SEA-CD40 Drug: SEA-CD40
Given intravenously at least every 3 weeks. Number of cycles: until progression or unacceptable toxicity develops.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Incidence of adverse events
[ Time Frame: Through up to approximately 6 weeks following last dose ]

2. Incidence of chemistry and hematology laboratory abnormalities
[ Time Frame: Through up to approximately 6 weeks following last dose ]

Secondary Outcome Measures:
1. Blood concentrations of SEA-CD40
[ Time Frame: Through up to approximately 6 weeks after dosing ]

2. Incidence of antitherapeutic antibodies against SEA-CD40
[ Time Frame: Through up to approximately 6 weeks after dosing ]

3. Mean absolute and percent change from baseline over time of selected pharmacodynamic markers
[ Time Frame: Through up to approximately 6 weeks after dosing ]

4. Objective response rate
[ Time Frame: Through up to approximately 6 weeks following last dose ]

5. Disease control rate
[ Time Frame: Through up to approximately 6 weeks following last dose ]

6. Duration of response
[ Time Frame: Up to approximately 3 years ]

7. Progression-free survival
[ Time Frame: Up to approximately 4 years ]

Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • Histologically confirmed advanced metastatic or unresectable solid malignancy
  • Relapsed, refractory, or progressive disease following at least 1 prior systemic therapy
  • Representative baseline tumor tissue sample is available
  • No further standard therapy is available for the patient's advanced solid tumor at the time of enrollment
  • Measurable disease
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Adequate baseline hematologic, renal, and hepatic function
  • Recovery to Grade 1 of any clinically significant toxicity prior to initiation of study drug administration

Exclusion Criteria:

  • Prior chemotherapy, small molecule inhibitors, radiation, and/or other investigational anticancer agents (excluding investigational monoclonal antibodies) within 2 weeks
  • Prior immune-checkpoint inhibitors within 4 weeks
  • Prior monoclonal antibodies, antibody-drug conjugates, radioimmunoconjugates, or T-cell or other cell-based therapies within 12 weeks; or 2 weeks if patient experienced disease progression on the prior treatment
  • Recent or ongoing serious infections within 2 weeks
  • Active autoimmune or auto-inflammatory ocular disease within 6 months
  • Known or suspected active organ-threatening autoimmune disease
  • Prior or current central nervous system tumor or metastases
Open or close this module Contacts/Locations
Central Contact Person: Terri Lowe
Telephone: 866-333-7436
Email: clinicaltrials@seagen.com
Study Officials: Stanford Peng, MD, PhD
Study Director
Seagen Inc.
Locations: United States, Oregon
Providence Portland Medical Center
[Recruiting]
Portland, Oregon, United States, 97213
Contact:Contact: Scot Lary 503-215-2604 john.lary@providence.org
Contact:Principal Investigator: Brendan Curti, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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