ARR-217 / ArriVent, Lepu Biopharma - LARVOL DELTA

First-in-human study of MRG007 (ARR-217), a CDH17-directed exatecan ADC, in patients with locally advanced or metastatic solid tumors (ESMO 2026) - No abstract available

ADC • Clinical • First-in-human • Late-breaking abstract • Metastases • P1 data • Oncology • Solid Tumor • CDH17

Four clinical studies selected for presentation at 2026 ESMO congress: CMG901 (AZD0901) clinical trial results selected as LBA for proffered paper presentation at presidential symposium, MRG007 clinical trial results selected as LBA for rapid oral presentation, and two other studies selected for rapid oral presentation (HKEXnews) - "(1) the Phase III clinical trial of CMG901 in second or later-line (2L+) advanced/metastatic Claudin 18.2-positive gastroesophageal carcinoma ('GEC') has been accepted for presentation as a late-breaking abstract ('LBA') for Proffered Paper presentation at the Presidential Symposium; (2) the Phase I clinical study of MRG007...for the treatment of colorectal cancer ('CRC') has been selected as an LBA for rapid oral presentation; (3) the Phase II study in Europe for the combination therapy of MRG003 and HX008 targeting locally advanced head and neck squamous cell carcinoma ('LA-HNSCC') has been selected for rapid oral presentation; and (4) the Phase II study for the combination therapy of MRG003 and HX008 in epidermal growth factor receptor-positive ('EGFR-positive') unresectable anaplastic/poorly differentiated thyroid cancer has been selected for rapid oral presentation, at the 2026 European Society for Medical Oncology (the 'ESMO') Congress."

Late-breaking abstract • P1 data • P2 data • P3 data • Colorectal Cancer • Gastroesophageal Cancer • Squamous Cell Carcinoma of Head and Neck • Thyroid Gland Carcinoma

Upcoming Milestones:…Initial Phase 1 data for ARR-217 (GlobeNewswire) - "Initial Phase 1 dose escalation data for ARR-217 planned to be presented at a future medical conference."

P1 data • Solid Tumor

A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=572 | Recruiting | Sponsor: ArriVent BioPharma, Inc. | N=405 ➔ 572 | Trial primary completion date: May 2029 ➔ Mar 2028

Enrollment change • Trial primary completion date • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CDH17

A Study of MRG007 Combination Therapy for Advanced Colorectal Cancer (clinicaltrials.gov) - P1/2 | N=316 | Not yet recruiting | Sponsor: Lepu Biopharma Co., Ltd.

New P1/2 trial • Colorectal Cancer • Oncology • Solid Tumor

ArriVent received FDA IND clearance for ARR-217 and dosed its first patient in March 2026 and continues to advance the ongoing Phase 1 dose escalation for ARR-217, a CDH17 targeted ADC, in gastrointestinal malignancies (The Manila Times) - "Complete Phase 1 dose escalation and initiate dose optimization for ARR-217, a CDH17 targeting ADC program, in the second half of 2026."

Trial status • Gastric Cancer • Gastrointestinal Cancer

MRG007, a cadherin 17-targeted, glycan-linked, exatecan-based antibody-drug conjugate, demonstrated potent anti-tumor activity and a good safety profile in preclinical studies (AACR 2025) - "Overall, the preclinical study results suggest that MRG007 is a differentiated and potent ADC drug candidate for the treatment of CDH17-expressing cancers in clinical trials."

ADC • Preclinical • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CDH17

Clinical advancement of ADC lead ARR-217 (MRG007) (GlobeNewswire) - "ArriVent...dosed its first patient in March 2026....Upcoming Milestones:...Plan to complete Phase 1 dose escalation and enter into dose optimization for ARR-217, a CDH17 targeting ADC program, in the second half of 2026."

Trial status • Colorectal Cancer • Gastric Cancer • Pancreatic Cancer

A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=405 | Recruiting | Sponsor: Lepu Biopharma Co., Ltd. | Phase classification: P1/2 ➔ P1

Phase classification • Colorectal Cancer • Gastric Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Clinical advancement of ADC lead candidate ARR-217 (MRG007). (GlobeNewswire) - "Phase 1 dose escalation continues in the Phase 1 study for ARR-217, a CDH17-targeted ADC, in gastrointestinal malignancies with our partner, Lepu Biopharma Co., Ltd. In addition, ArriVent has received FDA IND clearance for ARR-217."

IND • Trial status • Gastrointestinal Cancer

A Study of MRG007 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=336 | Recruiting | Sponsor: Shanghai Miracogen Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Solid Tumor

A Study of MRG007 in Patients With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=336 | Not yet recruiting | Sponsor: Shanghai Miracogen Inc.

New P1/2 trial • Solid Tumor

ArriVent BioPharma Reports First Quarter 2025 Financial Results (GlobeNewswire) - "First IND for ARR-217 (MRG007), an antibody drug conjugate (ADC) targeting CDH17, submitted in China"

IND • Colorectal Cancer • Gastrointestinal Cancer • Pancreatic Cancer

ArriVent BioPharma Reports Full Year 2024 Financial Results (GlobeNewswire) - "Upcoming Milestones - EGFR PACC plans. Data from the FURTHER Phase 1b (NCT05364043) trial continues to mature for first-line firmonertinib monotherapy in NSCLC patients with EGFR PACC mutations. ArriVent expects to provide an update on our plans to develop firmonertinib in EGFR PACC mutant NSCLC in the first half of 2025. First IND Filing for ADC Program. ArriVent and its partner, Lepu BioPharma, plan to file the first IND for ARR-217 in the first half of 2025. Top-line pivotal Phase 3 data. Firmonertinib has reached its target enrollment in the FURVENT study. ArriVent anticipates having top-line data in 2025 and expects to provide an update on timing of the top-line Phase 3 data release in Q2 2025."

IND • P1 data • P3 data: top line • Non Small Cell Lung Cancer

ArriVent BioPharma Enters Exclusive License with Lepu Biopharma for MRG007, an Antibody Drug Conjugate for the treatment of Gastrointestinal Cancers (GlobeNewswire) - "ArriVent BioPharma...announced that it has entered into an exclusive license agreement with Lepu Biopharma...for MRG007, an antibody-drug conjugate (ADC) that can target several gastrointestinal (GI) cancers. Under the terms of the agreement, ArriVent obtains the exclusive rights to develop and commercialize MRG007 worldwide outside of Greater China which includes mainland China, Hong Kong, Macau and Taiwan....The first IND submission is planned for the first half of 2025 with an initial clinical development focus in CRC, pancreatic and other GI cancers."

IND • Licensing / partnership • Colorectal Cancer • Pancreatic Cancer