Drugs / VS-7375
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07020221 | Jun 2025 → Dec 2028 expected | colorectal cancer, non-small cell lung carcinoma, pancreatic ductal adenocarcinoma | Verastem, Inc. | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07659795 | Jul 2026 → Jun 2027 expected | colorectal cancer | Verastem, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07659782 | Jul 2026 → Jun 2027 expected | non-small cell lung carcinoma | Verastem, Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07644559 | Jun 2026 → Jun 2027 expected | pancreatic ductal adenocarcinoma | Verastem, Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-06-23 | Verastem, Inc. | Results VS-7375 Demonstrates Clinical Activity with a Favorable Safety and Tolerability Profile in TARGET-D 101 Phase 1/2 Clinical Trial in Patients with Advanced KRAS G12D-Mutated Solid Tumors verastem.com ↗
Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced positive preliminary data from the ongoing TARGET-D 101 Phase 1/2 clinical trial evaluating VS-7375, an investigational oral KRAS G12D (ON/OFF) inhibitor, with best-in-class potential, in patients with advanced KRAS G12D-mutated solid tumors. |
| 2026-06-06 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory FDA授予GFH375/VS-7375快速通道资格认定，用于治疗KRAS G12D突变型不可切除、局部晚期或转移性非小细胞肺癌 genfleet.com ↗
劲方医药（2595.HK）宣布GFH375/VS-7375（口服KRAS G12D抑制剂）获美国食品药品监督管理局 (FDA) 授予快速通道资格认定（FTD） |
| 2026-06-03 | Verastem, Inc. | Regulatory Verastem Oncology Announces U.S. FDA Fast Track Designation for VS-7375, an Oral and Potential Best-in-Class Investigational KRAS G12D (ON/OFF) Inhibitor for the Treatment of KRAS G12D-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer verastem.com ↗
the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to VS-7375, an oral and potential best-in-class investigational selective KRAS G12D (ON/OFF) inhibitor, for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially. |
| 2026-04-23 | Genfleet Therapeutics (Shanghai) Inc. | Results AACR LBA：两项GFH375/VS-7375临床前研究入选突破性研究摘要，展现产品强效抑瘤活性、持久通路抑制及多种联用方案开发潜力 genfleet.com ↗
LBA 183 | Strong durable tumor regressions with the KRAS G12D (ON/OFF) inhibitor VS-7375 in combination with PRMT5 inhibition in MTAP-deleted/KRAS G12D-mutant pancreatic cancer |
| 2026-03-17 | Verastem, Inc. | Results Verastem Oncology Announces Late Breaking and Regular Abstracts Accepted for Presentation at the AACR Annual Meeting 2026 verastem.com ↗
VS-7375 also showed deeper tumor regression compared to these RAS ON-only inhibitors in KRAS G12D-mutated lung and colorectal xenograft models. |
| 2026-03-04 | Verastem, Inc. | Results Verastem Oncology Reports Fourth Quarter and Full Year 2025 Financial Results and Highlights Recent Business Updates verastem.com ↗
Of the five efficacy evaluable patients in the VS-7375-101 study with at least one scan, four out of five patients have had a tumor reduction and were still on treatment. |
| 2025-11-04 | Verastem, Inc. | Results Verastem Oncology Reports Third Quarter 2025 Financial Results and Highlights Recent Business Updates verastem.com ↗
In the study, VS-7375 cleared both the 400 mg daily (QD) and the 600 mg QD monotherapy doses with no dose-limiting toxicities (DLTs) observed. |
| 2025-10-24 | Genfleet Therapeutics (Shanghai) Inc. | Results GFH375/VS-7375美国I/IIa期剂量递增试验显示初步抗肿瘤活性，未见一级以上消化道TRAE genfleet.com ↗
该试验针对经治晚期KRAS G12D突变型实体瘤患者开展并表现出抗肿瘤活性、未出现剂量限制性毒性事件，同时未见1级以上消化道治疗相关不良事件（TRAE）。 |
| 2025-10-23 | Verastem, Inc. | Results Verastem Oncology Announces Encouraging Preliminary Data from Ongoing Phase 1/2a Dose Escalation Trial of VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor, in Patients with KRAS G12D Mutant Solid Tumors verastem.com ↗
Of the five efficacy evaluable patients in the VS-7375-101 study with at least one scan, four out of five patients have had a tumor reduction and are still on treatment. |
| 2025-10-19 | Verastem, Inc. | Results Verastem Oncology Announces Updated Data from Partner GenFleet Therapeutics’ Phase 1/2 Monotherapy Study in China of GFH375 (VS-7375) in Advanced KRAS G12D Mutant Pancreatic Ductal Adenocarcinoma verastem.com ↗
GFH375 resulted in a 41% ORR for patients with heavily pre-treated pancreatic ductal adenocarcinoma (68% had received 2 or more prior lines of therapy) at the 600 mg daily dose |
| 2025-08-13 | Verastem, Inc. | Results Verastem Oncology Announces Late-Breaking Abstract from Partner GenFleet Therapeutics’ Study in China of GFH375 (VS-7375) in Advanced Non-Small Cell Lung Cancer at IASLC 2025 World Conference on Lung Cancer verastem.com ↗
GFH375 demonstrated an overall response rate (ORR) of 68.8% in non-small cell lung cancer (NSCLC) at the recommended Phase 2 dose of 600 mg QD |
| 2025-07-25 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory FDA授予GFH375（口服KRAS G12D抑制剂）快速通道资格认定，治疗局部晚期或转移性胰腺导管腺癌 genfleet.com ↗
劲方医药宣布GFH375/VS-7375（口服KRAS G12D抑制剂）获得美国食品药品监督管理局 (FDA) 授予快速通道资格认定，用于KRAS G12D突变局部晚期或转移性胰腺导管腺癌（PDAC）的一线及后线治疗。 |
| 2025-07-24 | Verastem, Inc. | Regulatory Verastem Oncology Granted Fast Track Designation for VS-7375 for the Treatment of KRAS G12D-mutated Locally Advanced or Metastatic Pancreatic Cancer verastem.com ↗
today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, for the first-line treatment of patients with KRAS G12D-mutated locally advanced or metastatic adenocarcinoma of the pancreas (PDAC) and for the treatment of patients with KRAS G12D-mutated locally advanced or metastatic PDAC who have received at least one prior line of standard systemic therapy. |
| 2025-06-02 | Verastem, Inc. | Results Verastem Oncology Announces Updated Data from Partner GenFleet Therapeutics’ Phase 1 Study in China of GFH375 (VS-7375), an Oral KRAS G12D (ON/OFF) Inhibitor verastem.com ↗ |
| 2025-04-24 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory GFH375（口服KRAS G12D抑制剂）海外临床试验申请获批，将进入美国I/IIa临床研究 genfleet.com ↗
劲方医药宣布GFH375/VS-7375（口服KRAS G12D抑制剂）临床试验申请获得美国食品药品监督局（FDA）批准，同意针对KRAS G12D突变晚期实体瘤患者开展临床试验。 |
| 2025-04-23 | Verastem, Inc. | Regulatory Verastem Oncology Announces U.S. IND Clearance of VS-7375, Oral KRAS G12D (ON/OFF) Inhibitor, Enabling Phase 1/2a Trial in Advanced Solid Tumors verastem.com ↗
today announced the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor for clinical evaluation. |
| 2025-04-09 | Genfleet Therapeutics (Shanghai) Inc. | Results AACR预告：劲方医药三款大、小分子产品临床前研究将登陆2025 AACR年会壁报 genfleet.com ↗
GFH375、西妥昔单抗联用的结直肠癌模型中，所有实验小鼠全部达到完全缓解。 |
| 2025-03-25 | Verastem, Inc. | Results Verastem Oncology Announces Multiple Presentations Focused on RAS/MAPK Pathway Inhibition at AACR Annual Meeting 2025 verastem.com ↗
VS-7375, when combined with cetuximab, demonstrated strong tumor regressions in preclinical KRAS G12D models, including complete responses in a colorectal cancer model |
| 2024-09-03 | Genfleet Therapeutics (Shanghai) Inc. | Results “七”开得胜，未来可期——聚焦劲方医药首届投资者开放日 genfleet.com ↗
上海胸科医院肿瘤科主任、GFH375国内研究Leading PI陆舜教授表示与氟泽雷塞相比，GFH375项目更加体现了劲方速度、更新的抑制机制有望带来更优的抗肿瘤活性，目前首例受试者已观察到明显的抗瘤活性。 |
| 2024-06-19 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory IND获批！劲方医药GFH375（口服KRAS G12D抑制剂）将启动单药I/II期临床研究 genfleet.com ↗
劲方医药宣布自主研发的KRAS G12D(ON/OFF)抑制剂GFH375临床试验申请获得国家药品监督管理局批准，同意公司针对KRAS G12D 基因突变的晚期实体瘤患者开展开放标签、多中心I/II期临床试验。 |
| 2024-04-09 | Genfleet Therapeutics (Shanghai) Inc. | Results AACR现场：劲方口服KRAS G12D抑制剂GFH375临床前研究登陆壁报，显示强效抗肿瘤活性及与RAF/MEK抑制剂联用潜力 genfleet.com ↗
多种动物模型在口服给药之后呈现剂量依赖式肿瘤消退；在颅内肿瘤模型中观察到显著的抗肿瘤活性，提示GFH375用于KRAS G12D突变型肿瘤脑转移病人的治疗潜力。 |
| 2024-03-05 | Verastem, Inc. | Results Verastem Oncology Announces Preclinical Presentations for New Oral G12D Inhibitor and for Avutometinib and Defactinib Combination as a Backbone of Therapy for RAS/MAPK Driven Cancers at AACR Annual Meeting 2024 verastem.com ↗
GFH375 (VS-7375), a potential best-in-class oral KRAS G12D (ON/OFF) inhibitor, demonstrated potent anti-tumor activity in pancreatic and colorectal cancer models; |
All press releases naming this drug 31 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | VS-7375 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07659782 ↗ |
| Action | Inhibit | “VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D (ON/OFF) inhibitor.” NCT07020221 ↗ |
| Modality | Small molecule | “VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D (ON/OFF) inhibitor.” NCT07020221 ↗ |
| Route | Oral | “VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D (ON/OFF) inhibitor.” NCT07020221 ↗ |
| Target | KRAS | “VS-7375 is a highly selective oral, non-covalent, small molecule KRAS G12D (ON/OFF) inhibitor.” NCT07020221 ↗ |