NCT05427383

A Randomized, Multicenter, Phase Ⅱ/Ш Clinical Study to Evaluate the Efficacy of KN026 in Combination With Chemotherapy in Subjects With HER2 Positive Advanced Unresectable or Metastatic Gastric Cancer (Including Gastro-esophageal Junction Adenocarcinoma) Who Have Failed First-line Therapy.

Recruiting now Phase 2/Phase 3 Last updated 11 December 2023

What this trial tests

Phase 2/Phase 3 trial testing KN026/Placbo Injection in Stomach Cancer in 286 participants. Currently enrolling.

Timeline

7 April 2022

Primary endpoint
1 November 2025

1 November 2026

Quick facts

Lead sponsor	Shanghai JMT-Bio Inc.
Phase	Phase 2/Phase 3
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	286
Start date	7 April 2022
Primary completion	1 November 2025
Estimated completion	1 November 2026
Sites	1 location across China

Drugs / interventions tested

• KN026/Placbo Injection — full drug profile →
• Paclitaxel Injection — full drug profile →
• Docetaxel Injection — full drug profile →
• Irinotecan Injection — full drug profile →

Conditions studied

• Stomach Cancer — all drugs for Stomach Cancer →

Sponsor

Shanghai JMT-Bio Inc. — full company profile →

Who can join

18 and older, any sex, with Stomach Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Progression Free Survival (PFS) according to RECIST 1.1 by IRC
  Time frame: Up to 2.5 years
  The time from the first dose of study treatment to the date of documented disease
• Overall Survival (OS) according to RECIST 1.1 by IRC
  Time frame: Up to 2.5 years
  The time from the first dose of study treatment until the date of death from any cause

Sponsor's own description

KN026-001 is a two-stage study (Open-label stage/Randomized stage). Open-label stage is designed to evaluate the safety and efficacy of KN026 and chemotherapy when given together. Randomized stage is designed to evaluate the OS and PFS in patients receiving KN026 and chemotherapy compared to patients receiving placebo and chemotherapy.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Gastric cancer treatment: recent progress and future perspectives.
   Guan WL, He Y, Xu RH. · · 2023 · cited 639× · PMID 37245017 · DOI 10.1186/s13045-023-01451-3
2. Antibodies to watch in 2025.
   Crescioli S, Kaplon H, Wang L, Visweswaraiah J, et al · · 2025 · cited 87× · PMID 39711140 · DOI 10.1080/19420862.2024.2443538
3. Biparatopic antibodies: therapeutic applications and prospects.
   Niquille DL, Fitzgerald KM, Gera N. · · 2024 · cited 41× · PMID 38439551 · DOI 10.1080/19420862.2024.2310890
4. HER2-Positive Gastric Cancer: The Role of Immunotherapy and Novel Therapeutic Strategies.
   Pous A, Notario L, Hierro C, Layos L, et al · · 2023 · cited 32× · PMID 37511163 · DOI 10.3390/ijms241411403
5. Targeted therapy and immunotherapy for gastric cancer: rational strategies, novel advancements, challenges, and future perspectives.
   Luo D, Liu Y, Lu Z, Huang L. · · 2025 · cited 31× · PMID 39923010 · DOI 10.1186/s10020-025-01075-y
6. HER2-Positive Gastric Cancer and Antibody Treatment: State of the Art and Future Developments.
   Scheck MK, Hofheinz RD, Lorenzen S. · · 2024 · cited 28× · PMID 38611014 · DOI 10.3390/cancers16071336
7. Clinical Progresses and Challenges of Bispecific Antibodies for the Treatment of Solid Tumors.
   Gu Y, Zhao Q. · · 2024 · cited 16× · PMID 39172329 · DOI 10.1007/s40291-024-00734-w
8. Bispecific Antibodies in Solid Tumors: Advances and Challenges.
   Shan KS, Musleh Ud Din S, Dalal S, Gonzalez T, et al · · 2025 · cited 12× · PMID 40565299 · DOI 10.3390/ijms26125838