[Translation] An open-label, multicenter, phase II, single-arm study to evaluate the efficacy and safety of CBP-1008 for injection in patients with folate receptor α (FRα)-positive, platinum-resistant advanced epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer

根据实体瘤疗效评价标准1.1版（RECIST V1.1）评估的客观缓解率（ORR）评价注射用CBP-1008单药治疗FRα阳性的铂耐药晚期上皮性卵巢癌、原发性腹膜癌和输卵管癌患者的疗效。

[Translation]

The efficacy of CBP-1008 injection as a monotherapy in patients with FRα-positive, platinum-resistant advanced epithelial ovarian cancer, primary peritoneal cancer, and fallopian tube cancer was evaluated based on the objective response rate (ORR) assessed according to RECIST V1.1.

Start Date15 Feb 2023

Sponsor / Collaborator

Coherent Biopharma Suzhou Co., Ltd.Startup

CTR20212205 / RecruitingPhase 1

多中心、开放、评价注射用 CBP-1008 周疗方案在 FOLR1 和/或 TRPV6 表达阳性的晚期恶性实体瘤患者中安全性、耐受性和药代动力学特征以及在选定适应症中扩展的 Ia、Ib 期研究

[Translation] A multicenter, open-label, Phase Ia and Ib study to evaluate the safety, tolerability, and pharmacokinetic characteristics of an 8-week treatment regimen of CBP-100 for injection in patients with advanced malignant solid tumors that are positive for FOLR1 and/or TRPV6 expression, and to expand in selected indications

主要目的： 1. 评估DLT并确定MTD； 2. 确定RP2D； 3. 评估CBP-1008的安全性、耐受性和免疫原性。次要目的： 1. 评估CBP-1008在晚期恶性实体瘤患者中的抗肿瘤活性； 2. 确定单次剂量下和多次剂量下CBP-1008及其主要代谢产物的PK特征。探索性目的： 1. 识别CBP-1008疗效的潜在预测性生物标志物。

[Translation]

Primary objectives: 1. Evaluate DLT and determine MTD; 2. Determine RP2D; 3. Evaluate the safety, tolerability and immunogenicity of CBP-1008. Secondary objectives: 1. Evaluate the anti-tumor activity of CBP-1008 in patients with advanced malignant solid tumors; 2. Determine the PK characteristics of CBP-1008 and its major metabolites at single and multiple doses. Exploratory objectives: 1. Identify potential predictive biomarkers for the efficacy of CBP-1008.

Start Date01 Sep 2021

Sponsor / Collaborator

Coherent Biopharma Suzhou Co., Ltd.Startup

NCT04740398 / RecruitingPhase 1

A Phase Ia/Ib, Open-Label, Multi-center, First in Human and Expansion Study to Assess the Safety, Tolerance, and Pharmacokinetics of the Novel Antitumor Agent CBP-1008 in Patients With Advanced Solid Tumors

The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of CBP-1008, a bi-specific ligand conjugated drugs in patients with advanced solid tumors.

Start Date06 Mar 2019

Sponsor / Collaborator

Coherent Biopharma Suzhou Co., Ltd.Startup

100 Clinical Results associated with FOLR1 x TRPV6 x Tubulin

100 Translational Medicine associated with FOLR1 x TRPV6 x Tubulin

0 Patents (Medical) associated with FOLR1 x TRPV6 x Tubulin

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