Drugs / CBX-12
Trials 4
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05691517 | Jun 2024 → Oct 2026 expected | metastatic malignant neoplasm | National Cancer Institute (NCI) | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04902872 | May 2021 → Jun 2025 | appendix cancer, breast cancer, esophageal cancer, gastric cancer +6 | Cybrexa Therapeutics | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT06730100 | Feb → Dec 2026 | colorectal carcinoma | National Cancer Institute (NCI) | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06315491 | Sep 2024 → Oct 2025 overdue | ovarian carcinoma, refractory malignant neoplasm | Cybrexa Therapeutics | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 7
| Date | Issuer | Release |
|---|---|---|
| 2024-09-16 | Cybrexa Therapeutics | Results Cybrexa Therapeutics Announces Positive Final Data at ESMO 2024 from Phase 1 Study of Peptide Drug Conjugate CBX-12 in Advanced Solid Tumors cybrexa.com ↗
Cybrexa Therapeutics, a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide drug conjugate (PDC) therapeutics, today announced positive final results from its Phase 1 clinical trial of CBX-12 (alphalex™ exatecan). |
| 2023-05-25 | Cybrexa Therapeutics | Results Cybrexa Therapeutics To Present Data at ASCO 2023 Highlighting First-In-Human, Dose-Finding Study of Lead Candidate CBX-12 cybrexa.com ↗
In addition, treatment with CBX-12 resulted in four objective responses. |
| 2022-10-28 | Cybrexa Therapeutics | Results Cybrexa Therapeutics Presents Findings from First-in-Human Study of CBX-12 as a Plenary Oral Presentation at 34th EORTC-NCI-AACR Symposium cybrexa.com ↗
This first-in-human study of CBX-12, an alphalex™ PDC in patients with advanced or metastatic solid tumors, demonstrates tolerability, safety and single-agent anti-tumor activity including two confirmed responses for patients receiving CBX-12. |
| 2021-10-26 | Cybrexa Therapeutics | Results Cybrexa Therapeutics Announces Data Demonstrating Early Signals of Efficacy and Powerful Potential of Antigen-Independent Tumor Targeting cybrexa.com ↗
The initial data show robust efficacy signals and tolerability in patients with metastatic cancer. |
| 2021-06-08 | Cybrexa Therapeutics | Results Cybrexa Therapeutics Announces Publication of Peer-Reviewed Article in NAR Cancer cybrexa.com ↗
The study found that CBX-12 displays pH selectivity, stability in plasma and selective delivery of exatecan to tumor cells versus healthy tissue. |
| 2021-03-23 | Cybrexa Therapeutics | Regulatory Cybrexa Therapeutics Receives Green Light from FDA on Investigational New Drug Application for CBX-12 (alphalex™-exatecan) cybrexa.com ↗
Cybrexa Therapeutics, an oncology-focused biotechnology company developing a new class of therapeutics through its alphalex™ Peptide Drug Conjugate (PDC) tumor targeting platform, today announced that the U.S. Food and Drug Administration (FDA) has provided the green light regarding the Investigational New Drug (IND) application for CBX-12 (alphalex™-exatecan), the company’s lead therapeutic candidate. |
| 2021-01-28 | Cybrexa Therapeutics | Results Cybrexa Therapeutics Reports Positive Results from GLP Toxicology Study of Lead Candidate CBX-12 (alphalex™-exatecan) cybrexa.com ↗
In the GLP toxicology studies CBX-12 was delivered via IV infusion, and based on multiple parameters, including mortality, clinical observations, body weights and food consumption, the results established a significant therapeutic index of ~20X over exatecan for CBX-12. |
All press releases naming this drug 17 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CBX-12 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05691517 ↗ |
| Modality | Other / unclassified | “CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety” NCT04902872 ↗ |
| Route | Intravenous | “Patients receive CBX-12 intravenously (IV)” NCT05691517 ↗ |
| Target | TOP1 | “CBX-12 works by binding to a protein called TOP1” NCT05691517 ↗ |