Drugs / GFH375
Trials 7
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT07259590 | Oct 2025 → Jul 2027 expected | colorectal cancer, pancreatic ductal adenocarcinoma | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06500676 | Jul 2024 → Jul 2028 expected | cancer | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07784374 | Aug 2026 → Aug 2028 expected | malignant pancreatic neoplasm | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
| Phase 2 | NCT07554859 | May 2026 → Apr 2027 expected | non-small cell lung carcinoma | Genfleet Therapeutics (Shanghai) Inc. | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07026916 | Aug 2025 → Aug 2027 | malignant pancreatic neoplasm | Genfleet Therapeutics (Shanghai) Inc. | Withdrawn | No outcome recorded Stop: Business |
| Phase 32 trials | ||||||
| Phase 3 | NCT07668752 | Jul 2026 → Jun 2030 expected | non-small cell lung carcinoma | Genfleet Therapeutics (Shanghai) Inc. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07262567 | Dec 2025 → Jun 2027 expected | malignant pancreatic neoplasm | Genfleet Therapeutics (Shanghai) Inc. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-09-28 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 劲方GFH375获第三项BTD：国内首个KRAS G12D抑制剂治疗结直肠癌突破性疗法认定 genfleet.com ↗ |
| 2026-09-16 | Genfleet Therapeutics (Shanghai) Inc. | Results Nature Medicine | 劲方医药GFH375（KRAS G12D抑制剂）I 期临床回顾：对经多线治疗的患者展现积极疗效，支持多瘤种注册性临床研究 genfleet.com ↗
GFH375在跨越多个剂量水平（100-900 mg QD）的早期研究中，已对经多线治疗的胰腺癌、非小细胞肺癌（NSCLC）等瘤种患者展现令人鼓舞的抗肿瘤活性与可控的安全性/耐受性。 |
| 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） |
| 2026-04-23 | 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 ↗
本次公布的研究还系统探索了RAS抑制剂的潜在耐药机制及可逆性，显示了GFH375超越KRAS G12D（ON）抑制剂的抗耐药潜力，并为多种联用方案提供了坚实的科学依据。 |
| 2026-04-09 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 劲方GFH375获第二项BTD认定：国内首个KRAS G12D抑制剂单药治疗方案纳入胰腺癌突破性疗法认定名单 genfleet.com ↗
劲方医药（2595.HK）宣布口服KRAS G12D（ON/OFF）抑制剂GFH375已被国家药品监督管理局药品审评中心纳入突破性疗法认定（BTD）名单，拟用于单药治疗至少接受过一种系统性治疗的KRAS G12D突变型转移性胰腺癌患者。 |
| 2026-03-02 | Genfleet Therapeutics (Shanghai) Inc. | Regulatory 国内首款KRAS G12D抑制剂纳入非小细胞肺癌突破性疗法！劲方医药GFH375获得CDE突破性疗法认定 genfleet.com ↗
劲方医药宣布其自主开发的口服KRAS G12D（ON/OFF）抑制剂GFH375已被国家药品监督管理局药品审评中心纳入突破性疗法认定名单，拟用于至少接受过一种系统性治疗的KRAS G12D突变型非小细胞肺癌（NSCLC）患者，为国内首个针对NSCLC治疗的KRAS G12D抑制剂突破性疗法认定。 |
| 2025-12-15 | Genfleet Therapeutics (Shanghai) Inc. | Results 2025年劲方医药投资者开放日圆满举办 genfleet.com ↗
周教授表示GFH375单药治疗胰腺导管腺癌（PDAC）的I/II期疗效超越同靶点药物，安全性则超越已进入III期的海外泛RAS抑制剂，因此研究中心对GFH375注册性III期研究充满信心。 |
| 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. |
| 2025-10-23 | 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 | Genfleet Therapeutics (Shanghai) Inc. | Results ESMO口头报告及LBA：劲方GFH375治疗晚期KRAS G12D突变型胰腺导管腺癌显示优秀疗效 genfleet.com ↗
共59例患者完成至少一次治疗后肿瘤评估：客观缓解率（ORR）为40.7%、疾病控制率（DCR）为96.7%；91.5%的患者靶病灶肿瘤缩小。 |
| 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。 |
| 2025-06-03 | Genfleet Therapeutics (Shanghai) Inc. | Results ASCO现场 | PDAC、NSCLC治疗展现优秀初步疗效，劲方KRAS G12D抑制剂GFH375研究数据登陆快速口头报告 genfleet.com ↗
初步研究数据显示了GFH375的良好口服生物利用度、高选择性抑瘤活性，以及对胰腺导管腺癌（PDAC）、非小细胞肺癌（NSCLC）患者的优秀初步疗效。 |
| 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 ↗ |
| 2025-04-30 | Genfleet Therapeutics (Shanghai) Inc. | Results AACR现场：GFH375临床前研究显示单药、联用疗法优越活性，单药动物实验展现剂量依赖式疗效及显著肿瘤消退 genfleet.com ↗
靶向药对照实验：在结直肠癌模型中，GFH375口服给药的实验小鼠2周后观察到显著的肿瘤消退、多数（7/8）达到部分缓解（≥30%肿瘤消退），同等日均剂量的RMC-9805【KRAS G12D (ON) 抑制剂】口服给药后实验小鼠呈现不同程度疾病进展。 |
| 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 |
| 2024-06-19 | 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 28 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GFH375 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07668752 ↗ |
| Action | Inhibit | “GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation.” NCT07668752 ↗ |
| Modality | Small molecule | “GFH375 is an oral, highly selective, non-covalent small-molecule inhibitor targeting the KRAS G12D mutation.” NCT07668752 ↗ |
| Route | Oral | “orally” NCT06500676 ↗ |
| Target | KRAS | “targeting the KRAS G12D mutation” NCT07668752 ↗ |