bozitinib (APL-101)

P2, N=300, Recruiting, Tianjin Medical University Second Hospital

P2, N=31, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China

P1/2, N=24, Recruiting, Washington University School of Medicine | Trial completion date: Sep 2029 --> May 2030 | Trial primary completion date: Sep 2027 --> Jun 2027

P2, N=165, Recruiting, Shanghai Chest Hospital; Shanghai Chest Hospital

P1/2, N=68, Not yet recruiting, Cancer Hospital Chinese Academy of Medical Sciences; Cancer Hospital Chinese Academy of Medical Sciences

P4, N=20, Recruiting, The First Affiliated Hospital, Zhejiang University School of Medicine; The First Affiliated Hospital, Zhejiang University School of Medicine | Not yet recruiting --> Recruiting

P2, N=120, Recruiting, Avistone Biotechnology Co., Ltd.

Vebreltinib has shown promising efficacy and a favorable safety profile in patients with METex14-mutant NSCLC.

P4, N=20, Not yet recruiting, The First Affiliated Hospital, Zhejiang University School of Medicine; The First Affiliated Hospital, Zhejiang University School of Medicine

KRASWT PDAC is molecularly distinct from KRASMUT and enriched with potentially actionable genetic variants. In our study, transcriptomic profiling revealed that the KRAS signaling cascade may play a key role in KRASWT PDAC. Our report of a KRASWT PDAC patient with TFG-MET rearrangement who responded to a cMET inhibitor further supports the pursuit of precision oncology in this sub-population. Identification of targetable mutations, perhaps through approaches like RNA-seq, can help enable precision-driven approaches to select optimal treatment based on tumor characteristics.

P1/2, N=156, Recruiting, Avistone Biotechnology Co., Ltd.

P1, N=6, Completed, CHABiotech CO., Ltd | Not yet recruiting --> Completed

P1/2, N=22, Recruiting, Washington University School of Medicine | Trial completion date: Sep 2027 --> Sep 2029

P2/3, N=84, Active, not recruiting, Beijing Pearl Biotechnology Limited Liability Company

P2, N=497, Recruiting, Apollomics Inc. | Phase classification: P1/2 --> P2 | N=344 --> 497

P1/2, N=22, Recruiting, Washington University School of Medicine | Trial completion date: Nov 2026 --> Sep 2027 | Trial primary completion date: Nov 2026 --> Sep 2027

48 patients received subsequent METi (crizotinib, n=20; capmatinib, n=15; bozitinib, n=4; tepotinib, n=3; amivantamab, n=3; cabozantinib, n=3; other, n=4; different METi in subsequent lines, n=4)... Robust and durable efficacy, particularly in the 1L setting, support early use of tepotinib in the treatment sequence. Almost half of this elderly population received subsequent treatment, higher than the 20%–30% reported for 1L CT/IO IPSOS trial in elderly patients (median age 75). METi treatment sequencing analyses are ongoing.

P3, N=131, Active, not recruiting, Beijing Pearl Biotechnology Limited Liability Company

P2, N=185, Recruiting, Beijing Pearl Biotechnology Limited Liability Company | Trial primary completion date: Dec 2022 --> Dec 2024

Most of the TRAEs were grade 1/2. Conclusions Vebreltinib showed promising efficacy and favorable safety in patients with METex14 mutant NSCLC.

All pts received radiotherapy and temozolomide as first-line...TT was dabrafenib/trametinib (9 pts), larotrectinib (2 pts), erdafitinib (4 pts), entrectinib (1 pt), vebreltinib (2 pts), capmatinib (1 pt), alpelisib (6 pts), ipatasertib+/-atezolizumab (12 pts)...We had a dramatic response to a MET inhibitor. Deeper explorations are needed in targeting FGFR e ROS1.

Blood and tumor biopsy are collected at baseline, prior to combination treatment (optional tumor biopsy) and at progression for exploratory analyses to help identify genomic alterations leading to drug tolerance and biomarkers that can predict for benefit of combination therapy. Dose level 1 has been completed with 1 dose-limiting toxicity and dose-level 2 began enrolling in August 2022.

If proven effective, this targeted multifaceted intervention protocol will be extended for more glioma patients as a protocol to evaluate the safety and efficacy of MET inhibitors.

48 pts received subsequent METi (20 crizotinib, 15 capmatinib, 4 bozitinib, 3 tepotinib, 3 amivantamab, 3 cabozantinib, 4 other; 4 pts received different METi in subsequent lines)...Almost half of this elderly population received subsequent Tx, higher than the 20–30% reported for 1L CT/IO IPSOS trial in elderly pts (median age 75). METi Tx sequencing analyses ongoing.

P1/2, N=344, Recruiting, Apollomics Inc. | N=201 --> 344 | Trial completion date: Dec 2022 --> Nov 2026 | Trial primary completion date: Dec 2022 --> Mar 2026

P1/2, N=22, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting

These data indicated that the MET-STAT4-PD-L1 axis and tumor-associated macrophages might enforce glioma immune evasion and were associated with poor prognosis in GBM samples, suggesting potential clinical strategies for targeted therapy combined with immunotherapy in patients with primary GBM.

P1/2, N=22, Not yet recruiting, Washington University School of Medicine | Trial completion date: Sep 2026 --> Jan 2027 | Initiation date: Nov 2021 --> Mar 2022 | Trial primary completion date: Sep 2026 --> Jan 2027

P1/2, N=22, Not yet recruiting, Washington University School of Medicine

Based on safety profiles, PK and efficacy analyses, 200mg BID was determined to be RP2D. Bozitinib was well-tolerated with manageable safety profiles when administered at RP2D. Preliminary antitumor activity was observed in patients with exon 14 skipping and/or amplification, particularly in those with NGS-identified exon 14 skipping.

P2, N=185, Recruiting, Beijing Pearl Biotechnology Limited Liability Company