[Translation] Phase II clinical study on the safety and efficacy of BEBT-109 combined with chemotherapy as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutation

主要目的：评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌的安全性。次要目的：评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌的有效性；评估BEBT-109联合培美曲塞和卡铂或顺铂一线治疗携带EGFR 20号外显子插入突变的局部晚期、复发或转移性非小细胞肺癌患者中药代动力学特征。

[Translation]

Primary objective: To evaluate the safety of BEBT-109 combined with pemetrexed and carboplatin or cisplatin as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations. Secondary objective: To evaluate the efficacy of BEBT-109 combined with pemetrexed and carboplatin or cisplatin as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations; To evaluate the pharmacokinetic characteristics of BEBT-109 combined with pemetrexed and carboplatin or cisplatin as first-line treatment for locally advanced, recurrent or metastatic non-small cell lung cancer with EGFR exon 20 insertion mutations.

Start Date22 Aug 2024

Sponsor / Collaborator

BeBetter Med, Inc.

NCT06514027 / Not yet recruitingPhase 2

A Multicenter, Open Phase II Clinical Study on the Safety and Efficacy of BEBT-109 Combined With Chemotherapy as First-Line Treatment for Non-Small Cell Lung Cancer Carrying EGFR Exon 20 Insertion Mutations

This is a multicenter, open Phase II clinical study to evaluate the efficacy, safety, and pharmacokinetic characteristics of BEBT-109 combined with injectable pemetrexed disodium and carboplatin or cisplatin injection as first-line treatment for locally advanced, recurrent, or metastatic non-small cell lung cancer carrying EGFR exon 20 insertion mutations.

Start Date01 Jul 2024

Sponsor / Collaborator

BeBetter Med, Inc.

ChiCTR2200059127 / SuspendedPhase 2IIT

A Multicenter, Open-label Phase II Trial to Evaluate the Efficacy and Safety of BEBT-109 in Patients with Locally Advanced or Metastatic Cancer of the EGFR 20 Exon Insertion Mutation

Start Date16 May 2022

Sponsor / Collaborator-

100 Clinical Results associated with BEBT-109

100 Translational Medicine associated with BEBT-109

100 Patents (Medical) associated with BEBT-109

Literatures (Medical) associated with BEBT-109

01 May 2024·Med

First-in-human phase I study of BEBT-109 in previously treated EGFR exon 20 insertion-mutated advanced non-small cell lung cancer

Article

Author: Liu, Li ; Wang, Zhan ; Zhang, Xing ; Lin, Shaoding ; Zhang, Yongchang ; Liu, Min ; Liu, Zhaoyi ; Song, Lianxi ; Wang, Ya ; Xu, Qinqin ; Zhang, Lin ; Yang, Nong ; Zhou, Chunhua ; Jiang, Wenjuan ; Xiao, Jiwen ; Zeng, Liang ; Qin, Haoyue ; Yan, Huan ; Deng, Li ; Xiong, Yi ; Wu, Fang

BACKGROUNDBEBT-109 is an oral pan-mutant-selective inhibitor of epidermal growth factor receptor (EGFR) that demonstrated promising antitumor potency in preclinical models.METHODSThis first-in-human study was a single-arm, open-label, two-stage study. Phase Ia dose-escalation study evaluated the safety and pharmacokinetics of BEBT-109 in 11 patients with EGFR T790M-mutated advanced non-small cell lung cancer (aNSCLC). Phase Ib dose-expansion study evaluated the safety and efficacy of BEBT-109 in 18 patients with EGFR exon 20 insertion (ex20ins)-mutated treatment-refractory aNSCLC. The primary outcomes were adverse events and antitumor activity. Clinical trial registration number CTR20192575.FINDINGSThe phase Ia study demonstrated no dose-limiting toxicity, no observation of the maximum tolerated dose, and no new safety signals with BEBT-109 in the dose range of 20-180 mg/d, suggesting that BEBT-109 had an acceptable safety profile among patients with EGFR T790M-mutated aNSCLC. Plasma pharmacokinetics of BEBT-109 showed a dose-proportional increase in the area under the curve and maximal concentration, with no significant drug accumulation. The dose-expansion study demonstrated that BEBT-109 treatment was tolerable across the three dose levels. The three most common treatment-related adverse events were diarrhea (100%; 22.2% ≥Grade 3), rash (66.7%; 5.6% ≥Grade 3), and anemia (61.1%; 0% ≥Grade 3). The objective response rate was 44.4% (8 of 18). Median progression-free survival was 8.0 months (95% confidence intervals, 1.33-14.67).CONCLUSIONPreliminary findings showed that BEBT-109 had an acceptable safety profile and favorable antitumor activity in patients with refractory EGFR ex20ins-mutated aNSCLC.FUNDINGNational Natural Science Foundation of China.

01 Feb 2021·Translational OncologyQ3 · MEDICINE

BEBT-109, a pan-mutant-selective EGFR inhibitor with potent antitumor activity in EGFR-mutant non-small cell lung cancer

Q3 · MEDICINE

ArticleOA

Author: Liu, Xinjian ; Liu, Haiqi ; Fan, Fushun ; Ma, Yaru ; Ye, Xiaolan ; Mo, Zhenxian ; Zhou, Minhua ; Luo, Liying ; Liang, Xiaotong ; Lin, Mingsheng ; Weng, Yunwo ; Cai, Xiong ; Qian, Changgeng

EGFR mutation-positive NSCLC tumors are highly heterogeneous, therefore, exploring an agent simultaneously targeting multiple EGFR mutations may be valuable for clinical practice. Compared with osimertinib, BEBT-109 shows more sensitive and extensive antitumor activity in EGFR mutant NSCLC, while sparing wild-type EGFR cell lines. Meanwhile, unlike the metabolite of osimertinib AZ5104, the main metabolites of BEBT-109 are found lacking in activity against wild-type EGFR cell lines. Preclinical and clinical studies demonstrate a unique pharmacokinetic profiles of BEBT-109 with rapid absorption and quick in vivo clearance without accumulation, which are conducive to minimizing the off-target toxicity of the covalent irreversible EGFR inhibitor. Oral administration of BEBT-109 induces tumor regression in EGFR exon 20 insertion xenografts, and even tumor disappearance in PC-9, HCC827 and H1975 xenograft models. Furthermore, in clinical trials, the objective responses were observed in NSCLC patients with EGFR T790M mutation in the first and second dosing cohorts. These findings demonstrate that BEBT-109, a potent pan-mutant-selective EGFR inhibitor with improved pharmacokinetic properties, might offer a promising new option for the treatment of multiple mutant-EGFR-driven NSCLC.

100 Deals associated with BEBT-109

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
EGFR ex20ins mutation in non-small cell lung cancer	Phase 2	CN	BeBetter Med, Inc.	11 Jul 2022
EGFR positive non-small cell lung cancer	Phase 2	CN	BeBetter Med, Inc.	13 Apr 2022
EGFR-mutated non-small Cell Lung Cancer	Phase 1	CN	BeBetter Med, Inc.	15 Jan 2020

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