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NCT06730100
CBX-12 for the Treatment of Metastatic Chemotherapy-Refractory Microsatellite Stable Colorectal Cancer
Phase 2 trial testing Biopsy Procedure in Metastatic Mismatch Repair Proficient Colorectal Carcinoma. Withdrawn.
1 December 2026
Quick facts
| Lead sponsor | National Cancer Institute (NCI) |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Start date | 17 February 2026 |
| Primary completion | 1 December 2026 |
| Estimated completion | 1 December 2026 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- Biopsy Procedure
- Biospecimen Collection — full drug profile →
- Computed Tomography
- Magnetic Resonance Imaging
- pH Low Insertion Peptide-exatecan Conjugate CBX-12 — full drug profile →
- X-Ray Imaging
Conditions studied
- Metastatic Mismatch Repair Proficient Colorectal Carcinoma — all drugs for Metastatic Mismatch Repair Proficient Colorectal Carcinoma →
- Refractory Mismatch Repair Proficient Colorectal Carcinoma — all drugs for Refractory Mismatch Repair Proficient Colorectal Carcinoma →
- Stage IV Colorectal Cancer AJCC v8 — all drugs for Stage IV Colorectal Cancer AJCC v8 →
Sponsor
National Cancer Institute (NCI)
Who can join
18 and older, any sex, with Metastatic Mismatch Repair Proficient Colorectal Carcinoma or Refractory Mismatch Repair Proficient Colorectal Carcinoma. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This phase II trial studies how well CBX-12 works in treating patients with microsatellite stable colorectal cancer that has spread to other parts of the body (metastatic) and is no longer responding to chemotherapy treatment (chemotherapy-refractory). The usual approach to treating colorectal cancer includes treatment with surgery, radiation, or Food and Drug Administration (FDA)-approved drugs such as trifluridine-tipiracil, bevacizumab, regorafenib, or fruquintinib. However, most metastatic colorectal patients progress through all approved treatments and eventually succumb to their disease. CBX-12 is a drug that contains a peptide (a substance that contains many amino acids \[molecules that join together to form proteins\]) called pHLIP, linked to an anticancer substance called exatecan. Upon administration, pHLIP gets inserted into the cellular membrane of tumor cells, delivering exatecan to kill them. Giving CBX-12 may work better than the usual approach in treating patients with metastatic chemotherapy-refractory microsatellite stable colorectal cancer.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Innovative Peptide Therapeutics in the Pipeline: Transforming Cancer Detection and Treatment.
Nsereko Y, Armstrong A, Coburn F, Al Musaimi O. · · 2025 · cited 2× · PMID 40725089 · DOI 10.3390/ijms26146815
Verify or expand the search:
- PubMed search for NCT06730100
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other National Cancer Institute (NCI) trials
Trials by the same sponsor.
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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 NCT06730100 (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 National Cancer Institute (NCI)
- Last refreshed: 6 October 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/NCT06730100.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing