P1, N=924, Recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

P1/2, N=206, Active, not recruiting, LaNova Medicines Zhejiang Co., Ltd. | Recruiting --> Active, not recruiting

P1, N=17, Completed, Turning Point Therapeutics, Inc. | Active, not recruiting --> Completed | N=42 --> 17

P1/2, N=304, Recruiting, Merck Sharp & Dohme LLC | Phase classification: P2 --> P1/2 | Trial completion date: Mar 2027 --> Jan 2026 | Trial primary completion date: Jan 2027 --> Jan 2026

P1, N=924, Not yet recruiting, Shanghai Hengrui Pharmaceutical Co., Ltd.

P1, N=30, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.

P3, N=589, Recruiting, AstraZeneca

P2, N=25, Not yet recruiting, Harbin Medical University

P2, N=304, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting

P1/2, N=135, Recruiting, RemeGen Co., Ltd. | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2023 --> Sep 2025

P3, N=450, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.

P2, N=304, Not yet recruiting, Merck Sharp & Dohme LLC

P2, N=123, Recruiting, AstraZeneca

P1/2, N=20, Terminated, LaNova Australia Pty Limited | N=50 --> 20 | Trial completion date: May 2024 --> Nov 2023 | Recruiting --> Terminated; Sponsor's decision

41, 2023. Clinical trial information: NCT05980416.

These data support clinical development of the CLDN18.2-307-mAb and CLDN18.2-307-ADC for treatment of CLDN18.2+ cancers. Both are now being investigated in phase 1 clinical studies.

P1/2, N=269, Suspended, Sotio Biotech Inc. | Recruiting --> Suspended

P2, N=25, Not yet recruiting, First Affiliated Hospital of Anhui Medical University

Historically, progression-free survival (PFS) hovers around 7 months and overall survival (OS) around 14 to 16 months. However, depending on the dose, PFS with CMG901 ranged from 3.3 to 14.5 months, and OS ranged from 8.5 months to not reached, after a median follow up of 6 months.

NCT04805307

CNS tumors exhibit subtype-specific expression of ADC targets including several FDA-approved for other indications. Clinical trials of ADCs in CNS tumors may therefore be warranted.

P1/2, N=206, Recruiting, LaNova Medicines Zhejiang Co., Ltd. | Enrolling by invitation --> Recruiting | N=128 --> 206

P1/2, N=50, Recruiting, LaNova Australia Pty Limited | Enrolling by invitation --> Recruiting | Trial primary completion date: Oct 2023 --> Feb 2024

P2, N=276, Recruiting, LaNova Medicines Zhejiang Co., Ltd. | Not yet recruiting --> Recruiting

P1/2, N=64, Recruiting, RemeGen Co., Ltd.

P1, N=42, Active, not recruiting, Turning Point Therapeutics, Inc. | Recruiting --> Active, not recruiting | Phase classification: P1/2 --> P1 | Trial completion date: Aug 2024 --> Jan 2024 | Trial primary completion date: Aug 2024 --> Jan 2024

P1, N=156, Recruiting, Antengene Biologics Limited | Not yet recruiting --> Recruiting

P1, N=0, Withdrawn, Conjupro Biotherapeutics, Inc. | N=72 --> 0 | Trial completion date: Mar 2025 --> Nov 2022 | Not yet recruiting --> Withdrawn | Trial primary completion date: Feb 2025 --> Nov 2022

P1, N=120, Recruiting, Elevation Oncology | Not yet recruiting --> Recruiting

Outlining the engineering of a Claudin18.2 targeting antibody; Outlining the preclinical development of SOT102, a novel PNU-based antibody– drug conjugate targeting Claudin18.2 -expressing cancers; Exploring combinations with immunotherapy

P1, N=120, Not yet recruiting, Elevation Oncology

The trial consists of the following modules: • Part A: First-in-human, CLDN18.2 agnostic, single-agent dose escalation trial of SOT102 in advanced or metastatic gastric/GEJ or pancreatic cancer patients • Part B gastric, GEJ cohort/pancreatic cohort: CLDN18.2 agnostic dose escalation trial of SOT102 in combination with SoC for first-line treatment of patients with advanced or metastatic gastric/GEJ cancer (SoC: mFOLFOX with nivolumab) or pancreatic cancer (SoC: nab-paclitaxel/gemcitabine), which will start once monotherapy SOT102 dose level 3 in Part A is deemed safe The following expansion cohorts are planned upon identification of the recommended phase 2 dose (RP2D): • Part C gastric, GEJ/pancreatic cohort: Single-agent SOT102 in CLDN18.2 positive gastric/GEJ cancer patients after two or more prior systemic therapies and in pancreatic cancer after one or more prior systemic therapies. Enrollment to dose level 4 of Part A and to dose level 1 in both cohorts of Part B are planned to begin in June 2023. Primary objectives and endpoints: -To determine the MTD and RP2D of SOT102 as monotherapy and in combination with first-line SoC treatment (Parts A and B) - To assess the efficacy of SOT102 in monotherapy and in combination with first-line SoC treatment by ORR (Parts C and D).

P2, N=276, Not yet recruiting, LaNova Medicines Zhejiang Co., Ltd.

P1, N=7, Completed, RemeGen Co., Ltd. | Active, not recruiting --> Completed | N=33 --> 7 | Trial primary completion date: Apr 2023 --> Nov 2022

Currently, several ADCs are under investigation in clinical trials for gastric cancer patients, targeting various receptors such as EGFR, HER-2, HER-3, CLDN18.2, Mucin 1, among others. This review offers a comprehensive exploration of ADC drug characteristics and provides an overview of the research progress in ADC-based therapies for gastric cancer.

P1, N=71, Not yet recruiting, Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

P1/2, N=42, Recruiting, Turning Point Therapeutics, Inc. | Trial completion date: May 2024 --> Aug 2024 | Trial primary completion date: Apr 2023 --> Aug 2024

SYSA1801 shows promising early signs of efficacy with a well-tolerated safety profile in pts with CLDN18.2-expressing resistant/refractory solid tumors, especially GC. Part 1 of the study is ongoing with part 2 to start when the optimized dose is determined in China; studies outside of Greater China including in the United States are being planned by Elevation Oncology. Clinical trial information: NCT05009966.