FOLR1 antagonists(Folate receptor alpha antagonists), TRPV6 antagonists(Transient receptor potential cation channel subfamily V member antagonists), Immunomodulators

Therapeutic Areas

NeoplasmsUrogenital Diseases

Active Indication

Advanced Malignant Solid NeoplasmBone metastasesMetastatic castration-resistant prostate cancer

Inactive Indication

Lung Cancer

Originator Organization

Coherent Biopharma Suzhou Co., Ltd.Startup

Active Organization

Coherent Biopharma Suzhou Co., Ltd.Startup

Inactive Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Structure

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Clinical Trials associated with CBP-1018

NCT04928612 / RecruitingPhase 1

An Open-Label, Non-randomized, Multi-center Phase I Study Evaluating the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of Bi-Ligand-Drug Conjugate CBP-1018 in Patients With Advanced Solid Tumors

This is an open-label, non-randomized, multi-center, phase I study of bi-ligand-drug conjugate CBP-1018 in patients with advanced solid tumors. This study will be conducted in 2 parts: Part A (Dose Escalation) and Part B (Dose Expansion). Both parts include screening period, treatment period, end of treatment (EOT)/withdrawal, safety follow-up (SFU) and long-term-follow-up (LTFU). CBP-1018 will be administrated on eligible subjects until disease progression, unacceptable toxicity, withdrawal of consent or Sponsor's decision to stop the study, etc.

Start Date04 Nov 2021

Sponsor / Collaborator

Coherent Biopharma Suzhou Co., Ltd.Startup

CTR20212655 / RecruitingPhase 1

评价注射用CBP-1018在晚期恶性实体瘤患者中安全性和耐受性、药代动力学及初步疗效的非随机、开放、首次用于人体的Ⅰ期临床研究

[Translation] A non-randomized, open-label, first-in-human Phase I clinical study to evaluate the safety and tolerability, pharmacokinetics, and preliminary efficacy of CBP-1018 for injection in patients with advanced malignant solid tumors

主要研究目的： 1. 评估CBP-1018在晚期恶性实体瘤患者中的安全性和耐受性； 2. Ⅰa期：确定CBP-1018在晚期恶性实体瘤患者的最大耐受剂量（MTD）和Ⅱ期推荐剂量（RP2D）； 3. Ⅰb期：评估CBP-1018在各种晚期恶性实体瘤患者的客观反应率（ORR）。次要研究目的： 1. Ⅰa期：评估CBP-1018在晚期恶性实体瘤患者的抗肿瘤活性； 2. Ⅰb期：评估CBP-1018在各种晚期恶性实体瘤患者除ORR外的其他疗效指标； 3. 评估CBP-1018和MMAE在晚期恶性实体瘤患者中的药代动力学（PK）特征； 4. 评估在晚期恶性实体瘤患者中的免疫原性。探索性目的： 1. 探索与CBP-1018疗效相关的生物标志物； 2. 探索mCRPC神经内分泌或小细胞转化与CBP-1018疗效的关系； 3. 尽可能获得CBP-1018在人体内的药物代谢产物信息。

[Translation]

Main study objectives: 1. To evaluate the safety and tolerability of CBP-1018 in patients with advanced malignant solid tumors; 2. Phase Ia: To determine the maximum tolerated dose (MTD) and phase II recommended dose (RP2D) of CBP-1018 in patients with advanced malignant solid tumors; 3. Phase Ib: To evaluate the objective response rate (ORR) of CBP-1018 in patients with various advanced malignant solid tumors. Secondary study objectives: 1. Phase Ia: To evaluate the anti-tumor activity of CBP-1018 in patients with advanced malignant solid tumors; 2. Phase Ib: To evaluate other efficacy indicators of CBP-1018 in patients with various advanced malignant solid tumors except ORR; 3. To evaluate the pharmacokinetic (PK) characteristics of CBP-1018 and MMAE in patients with advanced malignant solid tumors; 4. To evaluate the immunogenicity in patients with advanced malignant solid tumors. Exploratory purpose: 1. Explore biomarkers related to the efficacy of CBP-1018; 2. Explore the relationship between mCRPC neuroendocrine or small cell transformation and the efficacy of CBP-1018; 3. Obtain as much information as possible on the drug metabolites of CBP-1018 in the human body.

Start Date04 Nov 2021

Sponsor / Collaborator

Coherent Biopharma Suzhou Co., Ltd.Startup

100 Clinical Results associated with CBP-1018

100 Translational Medicine associated with CBP-1018

100 Patents (Medical) associated with CBP-1018

Literatures (Medical) associated with CBP-1018

01 Nov 2024·Talanta

LC-MS/MS method for dual-ligand peptide-drug CBP-1018 and its deconjugated payload MMAE including sample stabilization strategy for its MC-Val-Cit-PABC linker

Article

Author: Li, Xianjing ; Shu, Chang ; Cheng, Minlu ; Song, Qinxin ; Zou, Bingjie ; Ding, Li ; Wang, Yiya

Recently, peptide-drug conjugate (PDC) has become the most promising conjugated drug for tumor therapy after antibody-drug conjugate due to stronger tumor penetration capacity and lower immunogenicity. CBP-1018 was a PDC with dual-ligand conjugated to MMAE via a cleavable linker (MC-Val-Cit-PABC) that can be lysed by cathepsins B. In this study, two specific LC-MS/MS methods were developed and validated for the determination of CBP-1018 and its metabolite MMAE in human plasma. To prevent the cleavable MC-Val-Cit-PABC linker from degradation, a protease inhibitor (cOmplete solution) was added to the pre-cooled vacuum tubes and the separated plasma samples. The assays involved the pretreatment of CBP-1018 by protein precipitation with H₂O-ACN (1:9, v/v) and the extraction of MMAE by liquid-liquid extraction with ethyl acetate under alkaline condition to eliminate the interference of CBP-1018 on MMAE. The two analytes showed good linearities over the calibration ranges (R² ≥ 9980). Both accuracy and precision met the acceptance criteria. The validated methods were successfully applied to the phase I dose-escalation study of CBP-1018 injection in Chinese patients with solid tumors to evaluate the pharmacokinetic properties of CBP-1018 and MMAE. The results showed that CBP-1018 was eliminated immediately after injection and MMAE reached the maximum exposure at approximately 2 h after infusion. The maximum concentration of MMAE did not exceed 20.0 ng/mL, suggesting that the off-target toxicity of CBP-1018 injection was controllable.

100 Deals associated with CBP-1018

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	CN	Coherent Biopharma Suzhou Co., Ltd.Startup	04 Nov 2021
Lung Cancer	Phase 1	CN	Coherent Biopharma Suzhou Co., Ltd.Startup	05 Nov 2020
Prostatic Cancer	Phase 1	CN	Coherent Biopharma Suzhou Co., Ltd.Startup	05 Nov 2020
Bone metastases	Phase 1	CN	Coherent Biopharma Suzhou Co., Ltd.Startup	-
Metastatic castration-resistant prostate cancer	IND Approval	US	Coherent Biopharma Suzhou Co., Ltd.Startup	12 Jun 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04928612 (ESMO2024) Manual	Phase 1	Metastatic castration-resistant prostate cancer	93	CBP-1018	(gyhepitxjq) = not yet reached prjhgjaxsb (zyocpmtilu ) View more	Positive	15 Sep 2024
NCT04928612 (ESMO2023) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	20	CBP-1018	(flylzvhjjb) = dqcvtvdxks orjmqgleqf (hagvahzctz ) View more	Positive	22 Oct 2023
NCT04928612 (ASCO2023) Manual	Phase 1	Solid tumor	14	CBP-1018	(iziggpbvff) = aavncsrqxk bsyaqtjrtc (xukcdiqgyh ) View more	Positive	26 May 2023
NCT04928612 (ASCO2023) Manual	Phase 1	Solid tumor	14	CBP-1018 (mCRPC)	(heyjfdrrcd) = wthvzfvrtz svgqbnkpkj (qmkdeqbawd ) View more	Positive	26 May 2023

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CBP-1018

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