Delving into the Latest Updates on TAVO-412 with Synapse

Overview

Basic Info

Drug Type

Trispecific antibody

Synonyms

Target

EGFR x VEGF x c-Met

Action

antagonists, inhibitors

Mechanism

EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), VEGF inhibitors(Vascular endothelial growth factor inhibitors), c-Met inhibitors(Hepatocyte growth factor receptor inhibitors)

Therapeutic Areas

NeoplasmsDigestive System DisordersRespiratory Diseases+ [2]

Active Indication

Adenocarcinoma of EsophagusGastrooesophageal junction cancerHepatocellular Carcinoma+ [5]

Inactive Indication-

Originator Organization

Tavotek Biotherapeutics Co. Ltd.

Active Organization

Tavotek Biotherapeutics Co. Ltd.

Tuochuang Biotechnology (Jiangsu) Co., Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

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TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of TAVO412. Part 1 will utilize a standard 3 + 3 design to determine the MTD/RP2D of TAVO412 in subjects with advanced or metastatic solid tumors who progressed on prior approved standard of care therapy. Part 2 will further evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacologic activity of TAVO412 in a new set of subjects with advanced or metastatic gastric cancer, non-small cell lung cancer (NSCLC), or subjects of other solid tumor types with best clinical responses (e.g., CR > PR > SD) from Part 1 that progressed on prior approved standard of care therapy.

Start Date20 Dec 2023

Sponsor / Collaborator

Tavotek Biotherapeutics Co. Ltd.

CTR20232871

/ RecruitingPhase 1

TAVO412在接受过标准治疗的晚期/转移性实体瘤患者中的两阶段、开放标签的I期研究

[Translation] A two-stage, open-label, Phase I study of TAVO412 in patients with advanced/metastatic solid tumors who have received prior standard therapy

主要目的：在经标准治疗失败或无标准治疗的晚期 /转移性实体瘤受试者中，评估 TAVO412的安全性、耐受性和剂量限制性毒性（ DLT），并确定 TAVO412在晚期或转移性实体瘤受试者中的最大耐受剂量 /推荐第 2阶段剂量（ MTD和 /或 RP2D）。次要目的：评估TAVO412在经标准治疗失败或无标准治疗的晚期或转移性实体瘤受试者中的药代动力学（ PK）、免疫原性和药效学（ PD）。根据RECIST v1.1，通过评估客观缓解率、疾病控制率、缓解持续时间、PFS和 OS来评估 TAVO412的初步疗效。研究肿瘤生物标志物的变化情况，并初步评估其和疗效之间的相关性。

[Translation]

Primary objective: To evaluate the safety, tolerability and dose-limiting toxicity (DLT) of TAVO412 in subjects with advanced/metastatic solid tumors who have failed or have no standard treatment, and to determine the maximum tolerated dose/recommended phase 2 dose (MTD and/or RP2D) of TAVO412 in subjects with advanced or metastatic solid tumors. Secondary objective: To evaluate the pharmacokinetics (PK), immunogenicity and pharmacodynamics (PD) of TAVO412 in subjects with advanced or metastatic solid tumors who have failed or have no standard treatment. The preliminary efficacy of TAVO412 was evaluated by evaluating the objective response rate, disease control rate, duration of response, PFS and OS according to RECIST v1.1. To study the changes in tumor biomarkers and preliminarily evaluate their correlation with efficacy.

Start Date04 Dec 2023

Sponsor / Collaborator

Tuochuang Biotechnology (Jiangsu) Co., Ltd.

NCT05548634

/ Active, not recruitingPhase 1

A 2-Part Open-Label Phase I Study of TAVO412 in Patients with Advanced or Metastatic Solid Tumors Who Progressed on Prior Approved Standard of Care Therapy

TAVO412 Phase 1 is an open-label, non-randomized, 2-part Phase I study to examine the safety, tolerability, pharmacokinetics/pharmacodynamics, and preliminary efficacy of TAVO412. Part 1 will utilize a standard 3 + 3 design to determine the MTD/RP2D of TAVO412 in subjects with advanced or metastatic solid tumors who progressed on prior approved standard of care therapy. Part 2 will further evaluate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK), and pharmacologic activity of TAVO412 in a new set of subjects with advanced or metastatic gastric cancer, non-small cell lung cancer (NSCLC), or subjects of other solid tumor types with best clinical responses (e.g., CR > PR > SD) from Part 1 that progressed on prior approved standard of care therapy.

Start Date08 May 2023

Sponsor / Collaborator

Tavotek Biotherapeutics Co. Ltd.

100 Clinical Results associated with TAVO-412

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100 Translational Medicine associated with TAVO-412

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100 Patents (Medical) associated with TAVO-412

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1

Literatures (Medical) associated with TAVO-412

Frontiers in Immunology

Developing transcriptomic biomarkers for TAVO412 utilizing next generation sequencing analyses of preclinical tumor models

Article

Author: Wu, Simin ; Ma, Bin ; Chiu, Mark L ; Zha, Zhengxia ; Mu, Guangmao ; Han, Chao ; Chen, Peng ; Jin, Ying ; Zhou, Huajun

IntroductionTAVO412, a multi-specific antibody targeting epidermal growth factor receptor (EGFR), mesenchymal epithelial transition factor (c-Met), and vascular endothelial growth factor A (VEGF-A), is undergoing clinical development for the treatment of solid tumors. TAVO412 has multiple mechanisms of action for tumor growth inhibition that include shutting down the EGFR, c-Met, and VEGF signaling pathways, having enhanced Fc effector functions, addressing drug resistance that can be mediated by the crosstalk amongst these three targets, as well as inhibiting angiogenesis. TAVO412 demonstrated strong in vivo tumor growth inhibition in 23 cell-line derived xenograft (CDX) models representing diverse cancer types, as well as in 9 patient-derived xenograft (PDX) lung tumor models.MethodsUsing preclinical CDX data, we established transcriptomic biomarkers based on gene expression profiles that were correlated with anti-tumor response or distinguished between responders and non-responders. Together with specific driver mutation that associated with efficacy and the targets of TAVO412, a set of 21-gene biomarker was identified to predict the efficacy. A biomarker predictor was formulated based on the Linear Prediction Score (LPS) to estimate the probability of patients or tumor model response to TAVO412 treatment. ResultsThis efficacy predictor for TAVO412 demonstrated 78% accuracy in the CDX training models. The biomarker model was further validated in the PDX data set and resulted in comparable accuracy. ConclusionsIn implementing precision medicine by leveraging preclinical model data, a predictive transcriptomic biomarker empowered by next-generation sequencing was identified that could optimize the selection of patients that may benefit most from TAVO412 treatment.

100 Deals associated with TAVO-412

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Esophagus	Phase 1	China	Tavotek Biotherapeutics Co. Ltd.	20 Dec 2023
Gastrooesophageal junction cancer	Phase 1	China	Tavotek Biotherapeutics Co. Ltd.	20 Dec 2023
Hepatocellular Carcinoma	Phase 1	China	Tavotek Biotherapeutics Co. Ltd.	20 Dec 2023
Locally Advanced Malignant Solid Neoplasm	Phase 1	China	Tavotek Biotherapeutics Co. Ltd.	20 Dec 2023
Non-Small Cell Lung Cancer	Phase 1	China	Tavotek Biotherapeutics Co. Ltd.	20 Dec 2023
Uterine Cervical Cancer	Phase 1	China	Tavotek Biotherapeutics Co. Ltd.	20 Dec 2023
Small Cell Lung Cancer	Phase 1	China	Tuochuang Biotechnology (Jiangsu) Co., Ltd.	04 Dec 2023
Advanced Malignant Solid Neoplasm	Phase 1	United States	Tavotek Biotherapeutics Co. Ltd.	08 May 2023

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05548634 (TAVO412, SABCS2023)	Phase 1	Triple Negative Breast Cancer EGFR \| cMet \| VEGF	-	TAVO412	mkuheyhkiq(ywebbpzfgp) = engaging the innate immune responses that include ADCC, ADCP, and CDC hegkffbxxz (gxgngtvdkl )	-	01 Mar 2023

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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