ATG-022 / Antengene - LARVOL DELTA

ATG-022, a Claudin 18.2 ADC, in Advanced Gastric and Gastroesophageal Junction Cancer (CLINCH): Phase 2 Results (ESMO 2026) - No abstract available

ADC • Metastases • P2 data • Oncology • Solid Tumor • CLDN18

CLINCH-3: A Study of ATG-022 Compared With Investigator's Choice of Treatment in Claudin 18.2-Positive Advanced Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P3 | N=380 | Not yet recruiting | Sponsor: Antengene Biologics Limited

New P3 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Antengene Announces First Patient Dosed in Pivotal Phase III CLINCH-3 Study of ATG-022 (PRNewswire) - "Initiated in China with the first patient dosed and planned for expansion into a multi-regional clinical trial (MRCT), the CLINCH-3 study is intended to generate robust clinical evidence to support a future marketing approval application for ATG-022 as monotherapy for CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

An open-label, multicenter, phase I study of ATG-022 in patients with advanced/metastatic solid tumors (CLINCH). (ASCO 2024) - P1 | "ATG-022 demonstrated preliminary anti-tumor activity, tolerability, safety, as well as comparable PK properties at current dose levels. The high affinity of sub-nM grade of ATG-022 in pts with low CLDN 18.2 expression needs further investigation. The dose escalation is ongoing and updated data will be presented."

Clinical • Metastases • P1 data • Gastric Cancer • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CLDN18

ATG-022: Data from P1b/2 trial (NCT07327229) in combination with pembrolizumab and CAPOX for 1L CLDN18.2+ gastric/GEJ adenocarcinoma in Q4 2026 (Antengene) - H1 2026 Results

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology

Antengene Corporation Limited…announced that two clinical abstracts featuring the latest results from the Phase II study of Claudin 18.2 antibody-drug conjugate (ADC) ATG-022 and the Phase Ib/II study of oral CD73 small-molecule inhibitor ATG-037 have been accepted for poster presentation at the 2026 European Society for Medical Oncology Annual Congress (ESMO 2026) (PRNewswire)

P1/2 data • P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Melanoma

Antengene Receives CDE Endorsement to Initiate Pivotal Phase III CLINCH-3 Study of ATG-022 in CLDN18.2+ Advanced Gastric/GEJ Cancer (PRNewswire) - "The CLINCH-3 study will be led by Prof. Lin Shen from Peking University Cancer Hospital as the principal investigator. This is a randomized, controlled, open-label, multicenter Phase III clinical study designed to evaluate the efficacy and safety of ATG-022 versus treatment of investigator's choice in patients with CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma. As a pivotal registrational study, CLINCH-3 is intended to support a future marketing approval application for ATG-022 as monotherapy for the treatment of CLDN18.2+ advanced gastric or gastroesophageal junction adenocarcinoma."

Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

CLINCH-2: A Phase Ib/II Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants With Claudin (CLDN) 18.2-positive, HER2-negative, Unresectable or Metastatic Gastric or Gastroesophageal Junction AdenocarcinomaUnresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=132 | Recruiting | Sponsor: Antengene Biologics Limited | Not yet recruiting ➔ Recruiting

Enrollment open • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

CLINCH: A Study of ATG-022 in Patients With Advanced/Metastatic Solid Tumors (clinicaltrials.gov) - P1 | N=156 | Recruiting | Sponsor: Antengene Biologics Limited | Trial completion date: Jun 2026 ➔ Dec 2027 | Trial primary completion date: Jun 2026 ➔ Dec 2027

Trial completion date • Trial primary completion date • Oncology • Solid Tumor • CLDN18

Key Clinical Programs: ATG-022 (CLDN18.2 Antibody-Drug Conjugate) (PRNewswire) - "The Company expects to release the latest clinical data of ATG-022 in the second quarter of 2026....Advancing clinical development across 1L to 3L gastric cancer: Antengene is currently conducting the Phase II CLINCH study and the Phase Ib/II CLINCH-2 study of ATG-022 in Mainland of China and Australia....In addition, the CLINCH study of ATG-022 includes a basket trial cohort evaluating multiple tumor types, with the majority of patients continuing to receive treatment."

P1 data • Trial status • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Solid Tumor

CLINCH-2: Study of ATG-022 Plus Pembrolizumab With/Without Chemotherapy in Participants Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov) - P1/2 | N=132 | Not yet recruiting | Sponsor: Antengene Biologics Limited

New P1/2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1

First Disclosure of Positive Clinical Signals of ATG-022 in Non-Gastrointestinal Tumors (PRNewswire) - "As of January 6, 2025, among 9 efficacy evaluable patients, the ORR was 22.2% (2/9), and DCR was 88.9% (8/9). These data suggest that ATG-022 may have the potential to treat CLDN18.2-positive non-gastrointestinal tumors, which could expand the treatable patient population beyond gastrointestinal cancers."

P1/2 data • Solid Tumor

Latest data from the Phase I/II CLINCH study (PRNewswire) - "As of December 25, 2025, among patients with moderate to high CLDN18.2 expression (IHC 2+ > 20%) in the 2.4 mg/kg dose cohort, the objective response rate (ORR) was 40% (12/30) and the disease control rate (DCR) was 90% (27/30), with a median progression-free survival (mPFS) of 5.09 months and a median overall survival (mOS) of 14.72 months. In the 1.8 mg/kg dose cohort, the ORR was 46.7% (14/30), the DCR was 86.7% (26/30), the mPFS was 6.97 months, and the mOS has not yet been reached. Among patients with low/ultra-low CLDN18.2 expression (IHC 2+ ≤ 20%) treated at the efficacious dose range of 1.8-2.4 mg/kg, the ORR was 28.6% (6/21)."

P1/2 data • Solid Tumor

Antengene Announces IND Approval in China for Phase Ib/II Study of ATG-022 (CLDN18.2 ADC) in Combination with KEYTRUDA (Pembrolizumab) ± Chemotherapy (PRNewswire) - "The study is designed to evaluate two combination regimens in patients with CLDN18.2-positive, HER2-negative, and PD-L1-positive (CPS≥1) unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma (GC/GEJC): ATG-022 in combination with pembrolizumab (A+P); and ATG-022 in combination with pembrolizumab plus the CAPOX chemotherapy regimen (A+P+C)....Antengene will continue to advance both the ongoing CLINCH study and the newly approved CLINCH-2 study, with plans to share updated results at upcoming medical conferences to further demonstrate the clinical potential of ATG-022."

New P1/2 trial • P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

Antengene Hosts 2025 R&D Day Showcasing Encouraging Clinical Data and Solid Progress with Investigational Programs (The Malaysian Reserve) - "...it will present the latest data and future plans for three mid/late-stage clinical programs, including ATG-022 (CLDN18.2 antibody-drug conjugate [ADC]), ATG-037 (oral CD73 small molecule inhibitor), and ATG-101 (PD-L1/4-1BB bispecific antibody). The company will also share the latest progress on ATG-125 (B7H3 x PD-L1 bispecific ADC): A B7H3 x PD-L1 targeted therapy featuring “'O + ADC' dual-effect molecules for the treatment of solid tumors and its AnTenGager™ T-cell engager (TCE) technology platform which incorporates steric hindrance masking, along with updates on several key preclinical programs."

Clinical data • Colorectal Cancer • Hematological Malignancies • Melanoma • Neuroendocrine Carcinoma • Non Small Cell Lung Cancer • Ovarian Cancer

Phase I/II study of claudin 18.2 ADC ATG-022 in patients with advanced gastric/gastroesophageal junction cancer (CLINCH) (ESMO 2025) - P1 | "Clinical trial identification ATG-022-ST-001, 18 Nov 2022. Conclusions ATG-022 demonstrated a manageable safety profile and encouraging preliminary antitumor effects in GC/GEJC pts in current dosing levels, suggesting further clinical investigation in pts with variable CLDN 18.2 expression. The enrollment of GC and other solid tumors is ongoing."

Clinical • Metastases • P1/2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • CLDN18

Antengene Presents Latest ATG-022 Clinical Data at ESMO 2025 Demonstrating Efficacy Across All CLDN18.2 Expression Levels and Exceptional Tolerability (PRNewswire) - "Among GC/GEJC patients with moderate/high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort observed 1 complete response (CR), 11 partial responses (PRs) and 15 stable diseases (SDs), resulting in an objective response rate (ORR) of 40% (12/30) and a disease control rate (DCR) of 90% (27/30). The median progression-free survival (mPFS) was 6.97 months and the 12-month overall survival (OS) rate was 66.2%. In the 1.8 mg/kg dose cohort, there were 1 CR, 9 PRs, and 11 SDs, resulting in an ORR of 40% (10/25) and a DCR of 84% (21/25)....Preliminary efficacy has been observed in other non-GI tumor types which will be reported at upcoming conferences."

P1 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

The Phase II dose expansion study of ATG-022 is going smoothly in China and Australia. (PRNewswire) - "In parallel, Antengene is actively preparing for combination therapy studies involving ATG-022 to further advance its clinical development."

New trial • Trial status • Gastroesophageal Junction Adenocarcinoma

Updated Data from the Ongoing Phase I/II CLINCH Study (PRNewswire) - "In patients with moderate-to-high CLDN18.2 expression (IHC 2+ > 20%), the 2.4 mg/kg dose cohort achieved an objective response rate (ORR) of 40% (12/30), including 1 complete response (CR), with a disease control rate (DCR) of 90% (27/30), a median progression-free survival (mPFS) of 6.97 months, a 6-month PFS rate of 51.1%, a 9-month overall survival (OS) rate of 82.7%, and a 12-month OS rate of 66.2%. The 1.8 mg/kg dose cohort achieved an ORR of 40% (10/25), including 1 CR, and a DCR of 84% (21/25)."

P1/2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer

ATG-022,was granted a Breakthrough Therapy designation by the Center for Drug Evaluation (CDE) of the...NMPA for the treatment of CLDN18.2-positive, HER-2 negative unresectable or metastatic...GC/GEJ in patients who have received at least two prior lines of therapy (PRNewswire) - "In the ongoing CLINCH Phase I/II clinical study, data show that ATG-022 demonstrated significant antitumor activity and a favorable safety profile."

Breakthrough therapy • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

ATG-022: “Efficacy across the wildest patient population CLDN 18.2 + gastric cancer including from high to ultra-low expressors”; Gastric cancer (Antengene) - Investor Presentation: “Durable responses demonstrated and one patient exceeding 24 months”

P1/2 data • Gastric Cancer • Oncology

Antengene Announces Poster Presentation of ATG-022 (Claudin 18.2 ADC) at ESMO 2025 (PRNewswire) - "Antengene Corporation Limited...announced that an abstract featuring the latest data from a Phase I/II study of the Claudin 18.2 antibody-drug conjugate (ADC), ATG-022, has been accepted for poster presentation at the 2025 European Society for Medical Oncology Annual Congress (ESMO 2025)....Details of the Poster Presentation:...Title: Phase I/II study of Claudin 18.2 ADC ATG-022 in patients with advanced gastric/ gastroesophageal junction cancer (CLINCH); Abstract Number: 2907; Presentation Number: 2113P; Date: October 19, 2025."

P1/2 data • Gastric Cancer • Gastroesophageal Cancer

Antengene Enters into a Global Clinical Collaboration with MSD to Evaluate ATG-022 (CLDN18.2 ADC) In Combination with KEYTRUDA (pembrolizumab) (PRNewswire) - "Antengene Corporation Limited...announced it has entered into a global clinical collaboration with MSD (Merck & Co., Inc., Rahway, NJ, USA) to evaluate the combination of ATG-022, a CLDN18.2-targeting antibody-drug conjugate (ADC), and MSD's anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors."

Commercial • Oncology • Solid Tumor

Safety and preliminary efficacy of ATG-022 in patients with advanced/metastatic gastric cancer (CLINCH). (ASCO-GI 2025) - P1 | "ATG-022 demonstrated a manageable safety profile, comparable PK properties in current dosing levels, and encouraging preliminary antitumor effects in GC pts from high CLDN 18.2 expression to low CLDN 18.2 expression, suggesting further clinical investigation in pts with variable CLDN 18.2 expression. The enrollment of GC and other solid tumors are ongoing."

Clinical • IO biomarker • Metastases • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • CLDN18

Antennova Presents Latest Phase I/II Data on ATN-022 in Advanced/Metastatic Gastric Cancer, Including an ORR of 42.9%, at ASCO GI 2025 (PRNewswire) - P1/2 | N=156 | CLINCH (NCT05718895) | Sponsor: Antengene Biologics Limited | "As of November 22, 2024, among 21 gastric cancer patients in dose expansion phase with CLDN 18.2 expression of IHC 2+ ≥ 20% who had at least 1 tumor evaluation, the overall response rate (ORR) was 42.9%, and the disease control rate (DCR) was 95.2% (9 partial responses [PRs] including 8 confirmed PRs; and 11 stable diseases [SDs]). Among 10 gastric cancer patients with CLDN 18.2 expression of IHC 2+ < 20% treated at efficacious doses of 1.8 – 2.4 mg/kg, the ORR was 30.0% (1 complete response [CR] and 2 PRs, all PR/CR were confirmed with CLDN 18.2 expression of IHC 2+ < 5%), and the DCR was 50.0%. The patient with CR has demonstrated durable response and has been on the study for over 14 months as of the cut-off date. ATN-022 demonstrated a manageable safety profile and promising preliminary antitumor activity in late stage gastric cancer patients across various levels of CLDN18.2 expression..."

P1/2 data • Gastric Cancer