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NCT06792435
XNW27011 Study of Advanced Solid Tumor Subjects Who Failed Standard Therapies.
Phase 1, PHASE2 trial testing XNW27011 in Pancreatic Adenocarcinoma Metastatic in 240 participants. Currently enrolling.
30 June 2025
Quick facts
| Lead sponsor | Evopoint Biosciences Inc. |
|---|---|
| Phase | Phase 1, PHASE2 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 240 |
| Start date | 27 July 2023 |
| Primary completion | 30 June 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
Conditions studied
- Pancreatic Adenocarcinoma Metastatic — all drugs for Pancreatic Adenocarcinoma Metastatic →
- Lung Cancer (NSCLC) — all drugs for Lung Cancer (NSCLC) →
- Ovarian Cancer — all drugs for Ovarian Cancer →
- Colorectal Cancer Metastatic — all drugs for Colorectal Cancer Metastatic →
Sponsor
Evopoint Biosciences Inc. — full company profile →
Who can join
18 and older, any sex, with Pancreatic Adenocarcinoma Metastatic or Lung Cancer (NSCLC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a global, multi-center, open-label, Phase I/II first-in-human study of XNW27011 monotherapy as an investigational product (IP) in patients with locally advanced and/or metastatic solid tumors who have failed or are intolerant to standard therapies. XNW27011 is an antibody-drug conjugate (ADC) targeting Claudin 18.2 (CLDN18.2), a transmembrane protein important to tight junctions. The study consists of 2 parts: Part 1 is the dose-escalation phase (Phase I), and Part 2 is the does-expansion phase (Phase II). In phase I part of the study, approximately 42 patients with locally advanced and/or metastatic solid tumors will be enrolled, irrespective of CLDN18.2 expression. However, the most recently available tumor tissue specimen will be collected (if available) for a retrospective CLDN18.2 expression confirmation. In phase II part of the study, only patients with confirmed CLDN18.2 expression by IHC in the central laboratory will be enrolled.The phase II part of the study will consist of the following four groups，Up to three dose cohorts for each patient group are planned currently. Each dose cohort will include approximately 20 patients. Approximately 240 patients evaluable will be enrolled in Phase Ⅱ part of the study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Antibody-drug conjugates targeting the cadherin, claudin and nectin families of adhesion molecules.
Katoh M, Loriot Y, Nakayama I, Hamada A, et al · · 2025 · PMID 41164107 · DOI 10.3389/fmmed.2025.1661016
Verify or expand the search:
- PubMed search for NCT06792435
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Pancreatic Adenocarcinoma Metastatic
Currently open trials in the same condition.
- NCT06396637 — PD-1 Antibody and Sapropterin Dihydrochloride in Patients With PDAC · Phase 2 · recruiting
- NCT06051851 — Penpulimab Combined With Anlotinib and Nab-paclitaxel Plus Gemcitabine as First-line Treatment for Advanced Metastatic P · Phase 2 · recruiting
- NCT05077800 — FOLFIRINOX + Elraglusib + Losartan In Pancreatic Cancer · Phase 2 · active not recruiting
Other Evopoint Biosciences Inc. trials
Trials by the same sponsor.
- NCT07327294 — A Phase I/II Study to Evaluate XNW34017 in Patients With Advanced or Metastatic Solid Tumor · Phase 1, PHASE2 · not yet recruiting
- NCT06987500 — A Study of PARG Inhibitor XNW29016 in Patients With Advanced Solid Tumors Who Failed Standard Treatment · Phase 1, PHASE2 · recruiting
- NCT06799637 — Study of XNW28012 in Subjects With Advanced Solid Tumors Who Failed Standard Treatments · Phase 1, PHASE2 · recruiting
- NCT06702995 — Study of XNW5004 Tablet in Combination With Enzalutamide in Subjects With Metastatic Castration-Resistant Prostate Cance · Phase 1, PHASE2 · recruiting
- NCT05204563 — Imipenem/Cilastatin-XNW4107 Versus Imipenem/Cilastatin/Relebactam for Treatment of Participants With Bacterial Pneumonia · Phase 3 · completed
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 NCT06792435 (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 Evopoint Biosciences Inc.
- Last refreshed: 7 February 2025
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/NCT06792435.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing