- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap
Enrollment open, Trial completion date, Trial primary completion date, Metastases: Testing How the Body Responds to the Drug CBX-12 in Patients With Advanced Solid Cancers (clinicaltrials.gov) - May 6, 2024
P1, N=35, Recruiting,
Trial completion date: Sep 2024 --> Mar 2025 | Trial primary completion date: May 2024 --> Jan 2025 Not yet recruiting --> Recruiting | Trial completion date: Mar 2025 --> Oct 2026 | Trial primary completion date: Mar 2025 --> Oct 2026
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap
Pilot study of CBX-12 pharmacodynamics in patients with advanced solid tumors. (Hall A; Poster Bd #: 318b) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2158;
P1, P1/2
Mandatory biopsies will be collected at baseline, 24-36 hours post first dose, and on cycle 3 day 1 to assess both short- and long-term effects of CBX-12 on the tumor. Mandatory research blood samples will be collected at specified timepoints for pharmacokinetic, circulating tumor cell, and cell-free DNA analyses.
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap
Enrollment closed, Trial completion date, Trial primary completion date: CBX-12-101: Study of CBX-12 in Subjects With Advanced or Metastatic Refractory Solid Tumors (clinicaltrials.gov) - Jan 17, 2024
P1/2, N=130, Active, not recruiting,
Mandatory research blood samples will be collected at specified timepoints for pharmacokinetic, circulating tumor cell, and cell-free DNA analyses. Recruiting --> Active, not recruiting | Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: Feb 2024 --> May 2024
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap, Exelixis
CBX-12-101: A first-in-human study of CBX-12, an alphalex (On Demand | Hall A; Poster Bd # 285) - Apr 26, 2023 - Abstract #ASCO2023ASCO_1788;
P1/2
Phase 2 expansion cohorts are planned in pts with platinum-resistant ovarian cancer and hormone-receptor positive, HER2 negative breast cancer. Clinical trial information: NCT04902872.
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap, Exelixis
Utilizing a pH sensitive peptide (pHLIP) for tumor targeted delivery of an immunogenic peptide motif (Section 15; Poster Board #18) - Mar 14, 2023 - Abstract #AACR2023AACR_4962;
pHLIP-conjugates have undergone extensive development for drug delivery, with one notable candidate CBX12 entering phase I clinical trials in 2021...Cumulatively, these initial results suggest that pHLIP-SIINFEKL can be delivered to tumors to recruit OT1 cells to engage in antigen recognition and lead to efficacy in tumor growth delay in vivo. This technology has the capability to provide a novel approach to decorate solid tumors with engineered antigens for enhanced immune recognition and anti-tumor efficacy.
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap, Exelixis
Journal, PD(L)-1 Biomarker, IO biomarker: Antigen-independent tumor targeting by CBX-12 (alphalex-exatecan) induces long-term antitumor immunity. (Pubmed Central) - Jan 5, 2023
CBX-12 stimulates expression of MHC 1 and PD-L1 and is an inducer of immunogenic cell death, producing long-term immune recognition of tumor cells and resultant antitumor immunity. The authors' data provide the rationale for exploring immunotherapy combinations with CBX-12 in clinical trials.
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap, ceralasertib (AZD6738) / AstraZeneca
Journal, Combination therapy: TOP1-DNA trapping by exatecan and combination therapy with ATR inhibitor. (Pubmed Central) - Jul 8, 2022
The combination of CBX-12 with ceralasertib significantly suppressed tumor growth in mouse xenografts. Collectively, our results demonstrate the potency of exatecan as a TOP1 inhibitor and its clinical potential in combination with ATR inhibitors, using SLFN11 and HRD as predictive biomarkers.
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap
[VIRTUAL] Cybrexa Therapeutics () - Jun 9, 2020 - Abstract #BIO2020BIO_198;
CBX-12 is an alphalex™ conjugate that includes the highly potent topoisomerase I inhibitor exatecan. CBX-12 was selected based on its strong efficacy and solid safety profile demonstrated to date in preclinical studies.
- |||||||||| alphalex-exatecan (CBX-12) / Cybrexa Therap
CBX-12: A low pH targeting alphalex™-exatecan conjugate for the treatment of solid tumors (Virtual Meeting II: E-Posters) - May 16, 2020 - Abstract #AACRII2020AACR-II_2928;
In contrast, in animals dosed with the equimolar free exatecan (1.15 mg/kg) there was substantial tumor growth accompanied by neutropenia and weight loss.This superior profile of CBX-12 allow us to greatly enhance efficacy relative to dosing equimolar amounts of unconjugated exatecan, which causes significant, dose-limiting bone marrow toxicity. We have demonstrated that CBX-12 is both safe and has potent anti-tumor activity in preclinical models, and we plan to rapidly move forward with the clinical development of CBX-12 as our lead candidate.
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