Safety Study of SEA-CD40 in Cancer Patients



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Skin Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Blood Cancer, Lymphoma, Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/26/2018
Start Date:February 2015
End Date:September 2022

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A Phase 1, Open-label, Dose-escalation Study of SEA-CD40 in Adult Patients With Advanced Malignancies

This study will examine the safety profile of SEA-CD40 given alone and in combination with
pembrolizumab. 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. Different dose regimens will
be evaluated. Different methods of administration may be evaluated. The pharmacokinetics,
pharmacodynamic effects, biomarkers of response, and antitumor activity of SEA-CD40 will also
be evaluated.

The study will be conducted in the following parts:

Part A: Intravenous (IV) monotherapy dose-regimen finding for solid tumors --
Dose-escalation, and possible dose-interval modification to lengthen the treatment cycle, to
define the IV SEA-CD40 monotherapy maximum tolerated dose (MTD) and/or the optimal biological
dose (OBD) regimens in patients with solid tumors. The ability to increase the dose intensity
(to give additional doses within a treatment cycle) may be evaluated.

Part B: IV monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor
expansion cohorts may be enrolled where patients will be treated with doses at or below the
IV SEA-CD40 monotherapy MTD and/or OBD determined in Part A.

Part C: IV monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible
dose-interval modification to lengthen the treatment cycle, to define the IV SEA-CD40
monotherapy MTD and/or the OBD regimens in patients with lymphomas. The ability to increase
the dose intensity (to give additional doses within a treatment cycle) may be evaluated.

Part D: IV monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion
cohorts may be enrolled where patients will be treated with doses at or below the IV SEA-CD40
monotherapy MTD and/or OBD determined in Part C.

Part E: Combination therapy dose-regimen finding for solid tumors -- IV SEA-CD40
dose-escalation to define the MTD and/or the OBD regimen to be administered in combination
with standard approved dose of pembrolizumab in patients with solid tumors.

Part F: Combination therapy solid tumor expansion cohorts -- Disease-specific solid tumor
expansion cohorts may be enrolled where patients will be treated with IV SEA-CD40 and
pembrolizumab combination therapy; doses of SEA-CD40 will be at or below the MTD and/or OBD
determined in Part E.

Part G: Subcutaneous (SC) injection (injected under the skin) monotherapy dose-regimen
finding for solid tumors -- Dose-escalation, and possible dose-interval modification to
lengthen the treatment cycle, to define the SC SEA-CD40 monotherapy maximum tolerated dose
(MTD) and/or the optimal biological dose (OBD) regimens in patients with solid tumors.

Part H: SC monotherapy solid tumor expansion cohorts -- Disease-specific solid tumor
expansion cohorts may be enrolled where patients will be treated with doses at or below the
SC SEA-CD40 monotherapy MTD and/or OBD determined in Part G.

(Note: There is no Part I)

Part J: SC monotherapy dose-regimen finding for lymphomas -- Dose-escalation, and possible
dose-interval modification to lengthen the treatment cycle, to define the SC SEA-CD40
monotherapy MTD and/or the OBD regimens in patients with lymphomas.

Part K: SC monotherapy lymphoma expansion cohorts -- Disease-specific lymphoma expansion
cohorts may be enrolled where patients will be treated with doses at or below the SC SEA-CD40
monotherapy MTD and/or OBD determined in Part J.

In Parts A, C, E, G, and J, a maximum feasible dose (MFD) will be defined if an MTD and/or
OBD cannot be identified. Parts B, D, F, H, and K will explore the recommended dosing regimen
once the MTD and/or OBD, or MFD (if the MTD and/or OBD cannot be identified) has been
determined.

Inclusion Criteria:

- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Histologically confirmed advanced
malignancy, either: (a) Metastatic or unresectable solid malignancy; or (b) Classical
Hodgkin lymphoma (HL), or diffuse large B-cell lymphoma (DLBCL), or indolent lymphoma
(including follicular lymphoma [FL])

- (Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Relapsed, refractory, or
progressive disease, specifically: (a) Solid tumors: Following at least 1 prior
systemic therapy, and no further standard therapy is available for the patient's
advanced solid tumor at the time of enrollment; or (b) Classical HL: Following at
least 2 prior systemic therapies in patients who are not candidates for autologous
stem cell transplant (SCT), or following failure of autologous SCT; or (c) DLBCL:
Following at least 1 prior systemic therapy; patients must have also received
intensive salvage therapy unless they refused or were deemed ineligible; or (d)
Indolent lymphoma: Following at least 1 prior chemoimmunotherapy regimen that included
an anti-CD20 monoclonal antibody and for which no other more appropriate treatment
option exists

- (Combination Therapy - Part E and Part F) -- Histologically or cytologically confirmed
advanced or metastatic solid malignancy for which pembrolizumab treatment is approved.
In Part F, other advanced solid tumor indications may be eligible as identified by the
Sponsor.

- Representative baseline tumor tissue sample is available

- Measurable disease

- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

- Adequate baseline hematologic, renal, and hepatic function

- Recovery to Grade 1 of any clinically significant toxicity attributed to prior
anticancer therapy prior to initiation of study drug administration

Exclusion Criteria:

- Prior chemotherapy, small molecule inhibitors, and/or other investigational anticancer
agents (excluding investigational monoclonal antibodies) within 4 weeks

- Prior radiotherapy: therapeutic radiotherapy within 4 weeks, or palliative
radiotherapy (to non-CNS disease) within 1 week

- Prior immune-checkpoint inhibitors within 4 weeks (or 8 weeks, if immuno-oncology
doublet used as the prior line of therapy)

- Prior monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates within
4 weeks (or 2 weeks if patient experienced disease progression on the prior treatment)

- Prior 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

- Known positivity for hepatitis B infection

- Known active hepatitis C infection

- Active autoimmune or auto-inflammatory ocular disease within 6 months

- Known or suspected active organ-threatening autoimmune disease

- Active central nervous system tumor or metastases

- Patients with lymphomas: prior allogeneic SCT

- Patients in Part E or Part F: history of severe immune-mediated adverse reactions or
severe hypersensitivity to pembrolizumab
We found this trial at
17
sites
3550 Jerome Avenue
Bronx, New York 10467
(718) 920-4321
Principal Investigator: Sanjay Goel, MD
Phone: 718-405-8515
Montefiore Medical Center As the academic medical center and University Hospital for Albert Einstein College...
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Bronx, NY
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1201 Camino de Salud Northeast
Albuquerque, New Mexico 87131
(505) 272-4946
Principal Investigator: Olivier Rixe
Phone: 505-925-0377
University of New Mexico Cancer Center It’s been 40 years since the New Mexico State...
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Albuquerque, NM
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Amitkumar Mehta, MD
Phone: 205-996-4673
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
Principal Investigator: Thomas Gajewski, MD, PhD
Phone: 773-702-1982
University of Chicago One of the world's premier academic and research institutions, the University of...
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Chicago, IL
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4805 Northeast Glisan Street
Portland, Oregon 97213
(503) 215-1111
Principal Investigator: Brendan Curti, MD
Phone: 503-215-5763
Providence Portland Medical Center We strive to give those we serve exceptional, compassionate health care...
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Portland, OR
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: David Smith, MD
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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Ann Arbor, MI
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Chapel Hill, North Carolina 27599
Principal Investigator: Juneko Grilley-Olson, MD
Phone: 984-974-8662
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Chapel Hill, NC
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Timothy Kuzel, MD
Phone: 312-942-8004
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Chicago, IL
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Cleveland, Ohio 44106
Principal Investigator: David Bajor
Phone: 800-641-2422
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Cleveland, OH
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Detroit, Michigan
Principal Investigator: Elisabeth Heath
Phone: 313-576-9816
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Detroit, MI
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Houston, Texas 77030
Principal Investigator: Hun Ju Lee, MD
Phone: 713-792-3850
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Houston, TX
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9280 W. Sunset Road Suite 100
Las Vegas, Nevada 89148
702.952.1251
Principal Investigator: Fadi Braiteh
Phone: 702-862-1104
Comprehensive Cancer Centers of Nevada Comprehensive Cancer Centers of Nevada (CCCN) is the award-winning multidisciplinary...
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Los Angeles, California 90048
Principal Investigator: Monica Mita, MD
Phone: 310-967-4322
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Rochester, Minnesota 55905
Principal Investigator: Svetomir Markovic, MD
Phone: 507-284-3137
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Salt Lake City, Utah 84106
Principal Investigator: Justin Call, MD
Phone: 801-269-0231
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2001 Santa Monica Blvd # 560W
Santa Monica, California 90404
Principal Investigator: Monica Mita, MD
Phone: 310-231-2181
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Seattle, Washington 98109
Principal Investigator: Andrew Coveler, MD
Phone: 206-288-7551
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Seattle, WA
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