A Phase 2, Open-Label, Single-Arm, Multicenter Study to Assess the Safety and Efficacy of ASP1650, a Monoclonal Antibody Targeting Claudin 6 (CLDN6), in Male Subjects With Incurable Platinum Refractory Germ Cell Tumors

The purpose of this study was to establish the recommended phase 2 dose (RP2D) of ASP1650 (Safety Lead-in Phase), as well as, evaluate the efficacy of ASP1650 as measured by confirmed objective response rate (ORR) (phase 2) in participants with incurable platinum refractory germ cell tumors.
This study also evaluated the following efficacy measures for confirmed objective response rate (ORR); clinical benefit rate (CBR); duration of response (DOR); and progression-free survival (PFS); as well as safety and tolerability; the effect of ASP1650 on changes in serum beta human chorionic gonadotropin (βhCG) and alpha-fetoprotein (AFP); and the pharmacokinetics of ASP1650.

Start Date19 Mar 2019

Sponsor / Collaborator

Astellas Pharma Global Development, Inc.

NCT02054351

/ CompletedPhase 1

A First-in-human Dose Escalation and Dose Finding Phase 1 Trial of IMAB027 in Patients With Recurrent Advanced Ovarian Cancer (OVAR)

Advanced ovarian cancer is a high medical need indication. Cure is not available to these patients and treatment has palliative intent. A proportion of advanced stage ovarian cancer expresses substantial levels of Claudin 6 (CLDN6), a carcino-embryonic transmembrane protein, which is absent from normal adult human tissue. IMAB027 is a monoclonal antibody that binds to CLDN6. Preclinically IMAB027 was shown to inhibit tumor growth and to kill cancer cells by antibody-dependent cellular cytotoxicity and complement-dependent cytotoxicity. This trial is a first-in-human dose escalation and dose finding Phase 1 trial of IMAB027 in patients with recurrent advanced ovarian cancer to assess the safety and tolerability, the pharmacokinetics, the antitumoral activity and the immunogenicity of IMAB027.

Start Date06 Feb 2014

Sponsor / Collaborator

Ganymed Pharmaceuticals AG

100 Clinical Results associated with IMAB-027

100 Translational Medicine associated with IMAB-027

100 Patents (Medical) associated with IMAB-027

Literatures (Medical) associated with IMAB-027

01 Oct 2022·Investigational New Drugs

A phase II study assessing the safety and efficacy of ASP1650 in male patients with relapsed refractory germ cell tumors

Article

Author: Adra, Nabil ; Funt, Samuel A ; Rosales, Matt ; Hanna, Nasser H ; Einhorn, Lawrence H ; Vaughn, David J ; Feldman, Darren R ; Arozullah, Ahsan

Claudin6(CLDN6) is a tight junction protein of claudin-tetraspanin family and is of the earliest molecules expressed in embryonic epithelium. CLDN6 is frequently aberrantly expressed in testicular germ-cell tumors(GCT). ASP1650 is a chimeric-mouse/human-IgG1 antibody directed against CLDN6. Two-part, open-label, phase-II trial investigating ASP1650 in patients with relapsed/refractory GCT and no curable options. Part1 was a safety lead-in to establish the recommended-phase-II-dose(RP2D). Part2 was a phase-II study designed to evaluate the antitumor effects of ASP1650. CLDN6 expression was centrally assessed on archival tumor tissue using immunohistochemistry. The primary objectives were to establish the RP2D(safety lead-in) and the antitumor activity(phase-II) of ASP1650. Nineteen male patients were enrolled: 6 patients in 1000 mg/m² safety lead-in group, and 13 in 1500 mg/m² group. Median age 37.2 years(range,20-58). Histology was non-seminoma in 17/19 patients. Median number of previous chemotherapy regimens was 3. Thirteen patients had prior high-dose chemotherapy. No dose-limiting toxicity events were reported at any study drug dose. A RP2D of 1500 mg/m² every 2 weeks was established. No partial or complete responses were observed. The study was stopped at the end of Simon Stage-I due to lack of efficacy. 15/16 subjects with available tissue had CLDN6 positive staining. The mean percent membrane staining was 71.6% and the mean membrane H score was 152.6(SD 76). ASP1650 did not appear to have clinically meaningful single-agent activity in relapsed/refractory GCT. CLDN6 expression seems ubiquitous in all elements of GCT and is worthy of investigation as a diagnostic biomarker and therapeutic target. (Clinical trial information: NCT03760081).

100 Deals associated with IMAB-027

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Refractory Malignant Germ Cell Tumor	Phase 2	United States	Astellas Pharma Global Development, Inc.	19 Mar 2019
Recurrent ovarian cancer	Phase 2	Germany	Ganymed Pharmaceuticals AG	06 Feb 2014
Recurrent ovarian cancer	Phase 2	Belgium	Ganymed Pharmaceuticals AG	06 Feb 2014

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03760081 (Pubmed) Manual	Phase 2	Germ Cell and Embryonal Neoplasms	19	ASP1650 (Part1)	-	Negative	27 Jun 2022
				ASP1650 (Part2)	(cbizybzhjr) = ebbudgfsob iehcwjpyjr (jufswizikd )
NCT03760081 (CTgov)	Phase 2	Refractory Malignant Germ Cell Tumor	19	ASP1650 (ASP1650, Dose Level 1)	dvpbjfiioh(mhfrumfdip) = xrzngguijx wunxwphjug (cqedvxfwfx, dhkzfwzmjk - ytxpdvzjnw) View more	-	10 Nov 2021
				ASP1650 (ASP1650, Dose Level 2)	dvpbjfiioh(mhfrumfdip) = fryavembjw wunxwphjug (cqedvxfwfx, sdhdqgbwph - gqmoqmbbbv) View more

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