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NCT05985707
KN026 Plus Chemotherapy ± KN-046 in HER2 Positive Colorectal Cancer and Biliary Carcinoma
Phase 2 trial testing KN026 in HER2-positive Colorectal Cancer in 80 participants. Not yet recruiting.
31 December 2026
Quick facts
| Lead sponsor | Peking University Cancer Hospital & Institute |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 15 August 2023 |
| Primary completion | 31 December 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- HER2-positive Colorectal Cancer — all drugs for HER2-positive Colorectal Cancer →
- HER2-positive Biliary Tract Cancer — all drugs for HER2-positive Biliary Tract Cancer →
Sponsor
Peking University Cancer Hospital & Institute
Who can join
18 and older, any sex, with HER2-positive Colorectal Cancer or HER2-positive Biliary Tract Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this Interventional clinical trial is to learn about the efficacy and safety of KN026 and chemotherapy ± KN046 in HER2-positive metastatic colorectal cancer and biliary tract cancer. Participants will receive standard first-line chemotherapy (capecitabine + oxaliplatin) combined with KN026 (a HER2-targeted bispecific antibody) ± KN046 （a PD-L1/CTLA-4 targeted bispecific antibody）.
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412 -
HER2-targeted therapy in colorectal cancer: a comprehensive review.
Benli Y, Arıkan H, Akbulut-Çalışkan Ö. · · 2025 · cited 4× · PMID 40087250 · DOI 10.1007/s12094-025-03887-0 -
Targeting HER2 in Metastatic Colorectal Cancer: Current Therapies, Biomarker Refinement, and Emerging Strategies.
Vaghi C, Tosi F, Mauri G, Bonazzina E, et al · · 2026 · cited 2× · PMID 41247589 · DOI 10.1007/s40265-025-02253-2 -
Advancements in Targeted Therapies for Colorectal Cancer: Overcoming Challenges and Exploring Future Directions.
Khelwatty SA, Puvanenthiran S, Seddon AM, Bagwan I, et al · · 2025 · cited 1× · PMID 40940907 · DOI 10.3390/cancers17172810 -
Colorectal cancer pathogenesis, oncogenic signaling networks and targeted therapeutic advances.
Chen Y, Zhang J, Ding Y, Zhu F, et al · · 2026 · PMID 41826571 · DOI 10.1186/s43556-026-00433-4
Verify or expand the search:
- PubMed search for NCT05985707
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of KN026
Trials testing the same drug.
- NCT07441460 — A Phase III Study of KN026 in Combination With HB1801 as Adjuvant Therapy for Resectable HER2-Positive Breast Cancer · Phase 3 · recruiting
- NCT07332533 — A Study of KN026-based Combination Therapy in HER2-positive Gastric Cancer · Phase 2, PHASE3 · not yet recruiting
- NCT06998771 — JSKN003 Combined Treatment of HER2-positive Gastric Cancer · Phase 2 · not yet recruiting
- NCT06747338 — A Phase III Study of KN026 in Combination With HB1801 ± Carboplatin as Neoadjuvant Treatment for Early or Locally Advanc · Phase 3 · recruiting
- NCT06023758 — Phase 2 Trial of KN026+KN046±XELOX in HER2-positive Locally Advanced GC · Phase 2 · 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)
- Trial protocol + status: ClinicalTrials.gov NCT05985707 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 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: 21 August 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/NCT05985707.
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