Primary objective: To evaluate the safety and tolerability of SGN-B6A monotherapy in Chinese patients with advanced solid tumors. Secondary objective: To evaluate the PK and immunogenicity of SGN-B6A. Exploratory objective: To evaluate the anti-tumor activity of SGN-B6A.

Start Date08 Aug 2024

Sponsor / Collaborator

BSP Pharmaceuticals SpA

[+2]

CTR20232550 / RecruitingPhase 3

一项在肿瘤相关静脉血栓栓塞（VTE）患者中比较Abelacimab与阿哌沙班对VTE复发和出血影响的多中心、随机、开放性、盲法终点评估的III期研究（ASTER）

[Translation] A phase III, multicenter, randomized, open-label, blinded endpoint evaluation study comparing abelacimab and apixaban on VTE recurrence and bleeding in patients with tumor-associated venous thromboembolism (VTE) (ASTER)

主要目的：在近期诊断为VTE的肿瘤患者中评估Abelacimab与阿哌沙班相比，在随机化后6个月内预防VTE复发方面是否具有非劣效性。如果证明了其具有非劣效性，则将评估优效性。次要目的：评估在随机化后6个月内，Abelacimab与阿哌沙班相比在预防大出血或CRNM出血复合终点事件方面是否具有优效性；Abelacimab与阿哌沙班相比在净临床获益（定义为无VTE复发或大出血或CRNM出血事件的生存期）方面是否具有优效性；Abelacimab与阿哌沙班相比在非死亡导致的永久终止治疗率方面是否具有优效性；Abelacimab与阿哌沙班相比在预防CRNM出血事件方面是否具有优效性; Abelacimab与阿哌沙班相比在预防大出血事件方面是否具有优效性; Abelacimab与阿哌沙班相比在预防GI大出血和GI CRNM出血复合终点事件方面是否具有优效性。评价Abelacimab与阿哌沙班相比在随机化后6个月内的安全性和耐受性，并在接受Abelacimab治疗的患者中评估注射部位反应、超敏反应和免疫原性的发生率。

[Translation]

Primary objective: To evaluate whether abelacimab is non-inferior to apixaban in preventing VTE recurrence within 6 months after randomization in cancer patients with recently diagnosed VTE. If non-inferiority is demonstrated, superiority will be assessed. Secondary objectives: To evaluate whether Abelacimab is superior to apixaban in preventing the composite endpoint of major or CRNM bleeding within 6 months after randomization; whether Abelacimab is superior to apixaban in net clinical benefit (defined as survival without VTE recurrence or major or CRNM bleeding events); whether Abelacimab is superior to apixaban in the rate of permanent discontinuation of treatment due to non-death; whether Abelacimab is superior to apixaban in preventing CRNM bleeding events; whether Abelacimab is superior to apixaban in preventing major bleeding events; whether Abelacimab is superior to apixaban in preventing the composite endpoint of GI major bleeding and GI CRNM bleeding. To evaluate the safety and tolerability of Abelacimab compared with apixaban within 6 months after randomization, and to assess the incidence of injection site reactions, hypersensitivity reactions, and immunogenicity in patients treated with Abelacimab.

Start Date09 May 2024

Sponsor / Collaborator

Quintiles Enterprise Management (Shanghai) Co., Ltd.

[+2]

CTR20232947 / RecruitingPhase 3

一项在中度至重度活动性溃疡性结肠炎受试者中评价ABX464每日一次诱导治疗的有效性和安全性的随机、双盲、安慰剂对照、多中心、3期研究

[Translation] A randomized, double-blind, placebo-controlled, multicenter, phase 3 study to evaluate the efficacy and safety of once-daily induction therapy with ABX464 in subjects with moderately to severely active ulcerative colitis

主要目的是比较ABX464与安慰剂在临床缓解方面的有效性。

[Translation]

The primary objective was to compare the effectiveness of ABX464 with placebo in achieving clinical remission.

Start Date12 Mar 2024

Sponsor / Collaborator

Creapharm Clinical Supplies SAS

[+3]

100 Clinical Results associated with Quintiles Enterprise Management (Shanghai) Co., Ltd.

0 Patents (Medical) associated with Quintiles Enterprise Management (Shanghai) Co., Ltd.

Literatures (Medical) associated with Quintiles Enterprise Management (Shanghai) Co., Ltd.

01 Jun 2022·Journal of Clinical Oncology

Global multi-center phase I trial of the intraperitoneal infusion of anti-EpCAM x anti-CD3 bispecific antibody catumaxomab for advanced gastric carcinoma with peritoneal metastasis.

Author: QI, Changsong ; Shen, Lin ; Kim, In-Ho ; Kim, Seung Tae ; Wang, Jufeng ; Cai, Shirong ; Wei, Jian Xin ; Lin, Cheng-Yao ; Wang, Jaw-Yuan ; Wu, Shikai ; Liang, Zhezhao ; Bai, Li-Yuan

e16102 Background: Advanced gastric cancer (GC) patients (pts) have high incidence of peritoneal metastasis (PM), resulting in ascites, cachexia and poor life quality. EpCAM is highly expressed on GC but no on peritoneum. Catumaxomab intraperitoneal infusion (i.p.) was previously demonstrated to eradicate EpCAM+ cancers and control the malignant ascites in Europe (Heiss. Int. J. Cancer.2010). We present initial safety, pharmacokinetics (PK), and efficacy from the multi-center phase I trial of Catumaxomab on GC pts with PM in Asian population (NCT04222114). Methods: GC pts who had progressed on at least two prior standard systemic therapies with peritoneal metastasis were enrolled. Pts received Catumaxomab i.p. of 10 μg, 20 μg, 50 μg and 150 μg on days 1, 4, 8 and 11, respectively in the 1st cycle. From the 2nd cycle, Pts received Catumaxomab i.p. of 20 μg, 50 μg, 150 μg on days 1, 4 and 8, respectively. The cycle was 42 days in Cohort A, and 28 days in Cohort B. Catumaxomab PK were evaluated, tumor measurements and quantification of ascites by five-point method (Oriuchi, JJCO,2005) were performed Q6W. The primary endpoint was overall survival (OS); secondary endpoints were response rate of ascites, progression-free interval of peritoneal metastatic lesions and puncture-free survival (PuFS); Data cut-off date was Jan 29,2022. Results: 17 pts from 14 sites (median age: 52.5 yr, ECOG PS: 0 [n=2], 1 [n=14], 2[n=1], Cohort A:9, Cohort B:8) were treated. There were no dose-limiting toxicities (DLTs). The most common treatment-emergent adverse event (TEAE) was pyrexia (76.5%) and abdominal pain (58.8%). Grade ≥3 treatment related adverse events (TRAE) of abdominal pain (23.5%), bilirubin conjugated increased (23.5%), lymphocyte count decreased (17.6%), ALT increased (11.8%), and AST increased (11.8%) were reported. No treatment related death or neurotoxicity occurred in the study. Median overall survival was 102 days (95%CI: 38-166), with 10 (58.8%) deaths observed. For ascites, CR+PR was observed in 4 cases (33%), no PD case was reported. No therapeutic ascites drainage was recorded after cycle 1. Median PuFS was 116 days (95%CI: 28-157). Median progression-free interval of peritoneal metastatic lesions was 102 days (95%CI: 38-166). PK: Catumaxomab concentrations in plasma increased in a dose-dependent manner and were similar to Caucasian population in Europe. Conclusions: This clinical study indicated that multiple cycles of Catumaxomab i.p. were safe and well tolerated in Asian population. PK profile was similar. Early efficacy signals were promising, especially in pts with ascites, which will be further investigated in phase 3 study. Clinical trial information: NCT04222114.

100 Deals associated with Quintiles Enterprise Management (Shanghai) Co., Ltd.

100 Translational Medicine associated with Quintiles Enterprise Management (Shanghai) Co., Ltd.

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