This study will examine the safety profile of SGN-CD70A. The study will test increasing doses of SGN-CD70A given every 3 weeks (or an alternate dosing schedule up to every 6 weeks) to small groups of patients. The goal is to find the highest dose of SGN-CD70A that can be given to patients without causing unacceptable side effects. The pharmacokinetics and antitumor activity of SGN-CD70A will also be evaluated.

Start Date01 Aug 2014

Sponsor / Collaborator

Seagen Inc.

100 Clinical Results associated with SGN-CD70A

100 Translational Medicine associated with SGN-CD70A

100 Patents (Medical) associated with SGN-CD70A

Literatures (Medical) associated with SGN-CD70A

12 Apr 2022·Blood Advances

Targeting CD70 in cutaneous T-cell lymphoma using an antibody-drug conjugate in patient-derived xenograft models

Article

Author: Yang, Chen-Yen ; Ai, Weiyun Z. ; Wen, Kwun Wah ; Moasser, Mark ; Hinds, Brian ; Pincus, Laura ; McCormick, Frank ; Wu, Chi-Heng ; Wang, Linlin ; Gill, Ryan

AbstractCD70 is a member of the tumor necrosis factor receptor superfamily. Emerging data indicate that CD70 may be a suitable target for various malignancies. We investigated the expression of CD70 in cutaneous and systemic T-cell lymphomas and conducted preclinical studies of SGN-CD70A, a CD70-directed antibody-drug conjugate (ADC), using patient-derived xenograft cutaneous T-cell lymphoma (CTCL PDX) models. CD70 expression was examined by immunohistochemical (IHC) stains in 49 diagnostic specimens of T-cell lymphomas. The activities of SGN-CD70A in growth inhibition and apoptosis induction were examined in CTCL cell lines and primary CTCL tumor cells. Using previously established CTCL PDXs, we conducted a dose-finding trial followed by a phase 2-like trial to evaluate the optimal dosing and the efficacy of SGN-CD70A in tumor-bearing PDX animals. The therapeutic efficacy of SGN-CD70A was measured by tumor-associated cell-free DNA (cfDNA) and survival of treated PDXs. We found that CD70 is highly expressed in T-cell lymphomas, especially in CTCL. SGN-CD70A inhibited cell growth and induced apoptosis in CD70-expressing CTCL cell lines and primary tumors cells. Additionally, SGN-CD70A at 100 μg/kg and 300 μg/kg prolonged the survival of PDXs in a dose-dependent manner. Finally, treatment with 3 doses of SGN-CD70A at 300 μg/kg was superior to a single-dose treatment in survival prolongation (median survival: 111 days vs 39 days; P = .017). Most importantly, multiple dosing of SGN-CD70A induced complete eradication of established tumors in PDXs measured by cfDNA. Our results demonstrated marked antitumor activity of SGN-CD70A in CTCL PDXs, providing compelling support for its clinical investigation.

15 Apr 2019·Investigational New DrugsQ3 · MEDICINE

A phase 1 trial of SGN-CD70A in patients with CD70-positive diffuse large B cell lymphoma and mantle cell lymphoma

Q3 · MEDICINE

Article

Author: Chen, Robert ; Boyd, Thomas ; Phillips, Tycel ; Kingsley, Edwin C ; Gartner, Elaina M ; Barr, Paul M ; Park, Steven I ; Yu, Cindy ; Carret, Anne-Sophie ; Chhabra, Saurabh ; Caimi, Paolo F ; Smith, David C ; Kolibaba, Kathryn ; Li, Hong

SummaryPurpose This first-in-human study evaluated SGN-CD70A, an antibody-drug conjugate (ADC) directed against the integral plasma membrane protein CD70 and linked to a pyrrolobenzodiazepine (PBD) dimer, in patients with relapsed or refractory (R/R) CD70-positive non-Hodgkin lymphoma (NHL) including diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma (MCL), and Grade 3b follicular lymphoma (FL3b). Methods SGN-CD70A was administered intravenously on Day 1 of 3-week cycles beginning at 8 mcg/kg with planned dose escalation to 200 mcg/kg. Due to observations of prolonged thrombocytopenia, the study was amended to dose every 6 weeks (q6wk). Results Twenty patients were enrolled and treated with SGN-CD70A. The maximum tolerated dose of SGN-CD70A was 30 mcg/kg q6wk. The most common adverse events (AEs) reported were thrombocytopenia (75%), nausea (55%), anemia (50%), and fatigue (50%). The onset for treatment-related thrombocytopenia typically occurred during Cycle 1. Most of the treatment-related events of thrombocytopenia were ≥ Grade 3. Antitumor activity in patients included 1 complete remission (CR) and 3 partial remissions (PRs), 2 of which were ongoing for at least 42.9 weeks. SGN-CD70A exposures were approximately dose proportional, with a mean terminal half-life of 3 to 5 days. Conclusions While modest single-agent activity was observed in heavily pretreated NHL patients, the applicability of SGN-CD70A is limited by the frequency and severity of thrombocytopenia, despite the long-term response with limited drug exposure.

100 Deals associated with SGN-CD70A

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
CD70 positive Neoplasms	Phase 2	US	Seagen Inc.	01 Aug 2014
Diffuse Large B-Cell Lymphoma	Phase 2	US	Seagen Inc.	01 Aug 2014
Follicular Lymphoma	Phase 2	US	Seagen Inc.	01 Aug 2014
Mantle-Cell Lymphoma	Phase 2	US	Seagen Inc.	01 Aug 2014
Renal Cell Carcinoma	Phase 2	-	Seagen Inc.	-
Renal Cell Carcinoma	Phase 2	-	Seagen Inc.	-

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02216890 (Pubmed \| Cancer) Manual	Phase 1	Metastatic Renal Cell Carcinoma CD70 Positive	18	SGN-CD70A	(udpatfliko) = thrombocytopenia (75%), nausea (55%), anemia (50%), and fatigue (50%) jtktlxblyz (aqvwgniqzl ) View more	Negative	01 Apr 2019

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