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NCT05985109
KN 046 Plus Regorafenib in MSS Metastatic Colorectal Cancer
Phase 2 trial testing KN046 in Colorectal Cancer in 98 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Peking University Cancer Hospital & Institute |
|---|---|
| Phase | Phase 2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 98 |
| Start date | 26 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 →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Peking University Cancer Hospital & Institute
Who can join
18 and older, any sex, with Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is an interventional Phase II clinical trial aiming to optimize immunotherapy strategies for microsatellite-stable colorectal cancer. We will include three types of metastatic colorectal cancer patients: those without liver metastasis, or carrying BRAF V600E mutation, or unable to tolerate chemotherapy as their initial or second-line treatment. The participants will receive a combination treatment of regorafenib and KN046 which is a PD-L1/CTLA-4 bispecific antibody. Treatment efficacy and safety profile would be evaluated in this study.
Publications & conference data
4 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 -
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 -
A comprehensive overview of the molecular features and therapeutic targets in BRAF<sup>V600E</sup>-mutant colorectal cancer.
Gu R, Fang H, Wang R, Dai W, et al · · 2024 · cited 8× · PMID 39073010 · DOI 10.1002/ctm2.1764 -
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
Verify or expand the search:
- PubMed search for NCT05985109
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT06099821 — KN046 Plus Regorafenib or Apatinib in MSI-H Digestive System Cancers Resistant to PD-1/PD-L1 Blockade · 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 recruiting trials for Colorectal Cancer
Currently open trials in the same condition.
- NCT07152821 — Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcino · Phase 3 · recruiting
- NCT07353645 — KRAS Neoantigen Nanovaccine as Adjuvant Therapy for Colorectal Cancer/Pancreatic Cancer · Phase 1, PHASE2 · recruiting
- NCT07432633 — [18F]FPyQCP PET Imaging of Fibroblast Activation Protein in Selected Oncology Indications · Phase 1, PHASE2 · recruiting
- NCT07523919 — Functional and Respiratory Determinants of Long-Term Colorectal Cancer Outcomes · recruiting
- NCT07529301 — Functional and Respiratory Predictors of Early Postoperative Outcomes · 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 NCT05985109 (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/NCT05985109.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing