NCT06099821 is a Phase 2 clinical trial of KN046 in Digestive System Cancers, sponsored by Peking University Cancer Hospital & Institute.

Who is sponsoring NCT06099821?

NCT06099821 is sponsored by Peking University Cancer Hospital & Institute.

What drugs are being tested in NCT06099821?

Interventions in NCT06099821: KN046, Regorafenib, Apatinib.

What condition does NCT06099821 study?

NCT06099821 studies Digestive System Cancers.

Is NCT06099821 still recruiting?

NCT06099821 is currently recruiting now. Last updated 26 October 2023.

Last reviewed 2023-10-26 · How we verify

NCT06099821

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade

Recruiting now Phase 2 Last updated 26 October 2023

What this trial tests

Phase 2 trial testing KN046 in Digestive System Cancers in 39 participants. Currently enrolling.

Timeline

25 October 2023

Primary endpoint
31 December 2026

31 December 2026

Quick facts

Lead sponsor	Peking University Cancer Hospital & Institute
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	39
Start date	25 October 2023
Primary completion	31 December 2026
Estimated completion	31 December 2026
Sites	1 location across China

Drugs / interventions tested

KN046 — full drug profile →
Regorafenib — full drug profile →
Apatinib (Apatinib) — full drug profile →

Conditions studied

Digestive System Cancers — all drugs for Digestive System Cancers →

Sponsor

Peking University Cancer Hospital & Institute

Who can join

18 and older, any sex, with Digestive System Cancers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is an interventional phase II clinical trial aiming to evaluate the efficacy and safety of KN046, a PD-L1 and CTLA-4 bispecific antibody, in combination with regorafenib or apatinib for microsatellite instability-high digestive system cancers resistant to PD-1/PD-L1 blockade. KN046 plus regorafenib will be given for patients with colorectal cancers, and KN046 plus apatinib will be given for patients with gastric cancers (including esophageal-gastric junction cancers) and other kinds of digestive system cancers.

Publications & conference data

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

Programmed cell death in tumor immunity: mechanistic insights and clinical implications.
Wang M, Yu F, Zhang Y, Li P. · · 2023 · cited 26× · PMID 38283351 · DOI 10.3389/fimmu.2023.1309635
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
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
Long-term survivals of immune checkpoint inhibitors as neoadjuvant and adjuvant therapy in dMMR/MSI-H colorectal and gastric cancers.
Wang Z, Cheng S, Yao Y, Liu S, et al · · 2024 · cited 12× · PMID 38967817 · DOI 10.1007/s00262-024-03764-9
Drug resistance in cancer: molecular mechanisms and emerging treatment strategies.
Li J, Hu J, Yang Y, Zhang H, et al · · 2025 · cited 5× · PMID 41247642 · DOI 10.1186/s43556-025-00352-w

Verify or expand the search:

Other trials of KN046

Trials testing the same drug.

NCT05832892 — Surufatinib Combined With KN046 and AG Regimen Chemotherapy as First-Line Treatment for Unresectable Advanced Pancreatic · Phase 1, PHASE2 · unknown
NCT05985109 — KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer · Phase 2 · recruiting
NCT06023758 — Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC · Phase 2 · recruiting
NCT05985707 — KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma · Phase 2 · not yet recruiting
NCT05827796 — IN10018+ Standard Chemotherapy (+KN046) in Subjects With Advanced Pancreatic Cancer · Phase 1, PHASE2 · recruiting

Other Peking University Cancer Hospital & Institute trials

Trials by the same sponsor.

NCT07527806 — Optimization of Dynamic Neoadjuvant Therapy Strategies for HER2-Positive Breast Cancer Based on HER2-PET/CT Molecular Im · Phase 2 · not yet recruiting
NCT07529002 — Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors · recruiting
NCT07417241 — SHR-A1811 vs Pyrotinib/Capecitabine in Trastuzumab-Resistant HER2+ Advanced Breast Cancer: A Randomized Study · Phase 2 · not yet recruiting
NCT07470203 — Pyrotinib Combined With Trastuzumab and Pertuzumab for Maintenance Therapy in HER2-Positive Advanced Breast Cancer · not yet recruiting
NCT07394192 — Short-Course Radiotherapy With Tumor-Draining Lymph Node Preservation Followed by PD-1 Inhibitors in pMMR/MSS Stage II-I · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06099821 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Peking University Cancer Hospital & Institute
Last refreshed: 26 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06099821.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing