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Association details:
| Biomarker: | CLDN18.2 expression |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | EO-3021 (Microtubule inhibitor, CLDN18.2-targeted antibody-drug conjugate) |
| Direction: | Sensitive |
Evidence:
Title:
Elevation Oncology Receives Fast Track Designation from the FDA for EO-3021 for the Treatment of Adult Patients with Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer Expressing Claudin 18.2
Published date:
09/23/2024
Excerpt:
Elevation Oncology...today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to EO-3021, a differentiated antibody drug conjugate (ADC), for the treatment of patients with advanced or metastatic gastric and gastroesophageal junction (GC/GEJ) cancer expressing Claudin 18.2 that has progressed on or after prior therapy.
Source:
Title:
Study of SYSA1801 in the Treatment of Claudin( CLDN) 18.2 Positive Advanced Malignant Solid Tumor
Excerpt:
...Subjects with locally advanced unresectable or metastatic malignant solid tumors confirmed by histology and/or cytology and CLDN 18.2 positive expression in the tumor tissue confirmed by the central laboratory: dose-escalation phase defined as IHC ≥ 1+ by central laboratory IHC assay; dose-expansion phase and extension cohort studies defined as CLDN18.2 expression in ≥ 40% of tumor cells, the IHC ≥ 2+); 4....
Trial ID:
Source:
Title:
Study of EO-3021 in Adult Patients With Solid Tumors Likely to Express CLDN18.2
Excerpt:
...- Select advanced or metastatic solid tumor that is likely to express CLDN18.2 such as gastric/GEJ, pancreatic and esophageal cancer...
Trial ID:
Less C2 evidence
Source:
Title:
First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in patients with resistant/refractory solid tumors.
Published date:
05/31/2023
Excerpt:
Among 17 evaluable pts with GC, ORR and DCR were 47.1% (95% CI: 23.0-72.2%, 8 PRs) and 64.7% (95% CI: 38.3-85.8%, 3 SDs)...SYSA1801 shows promising early signs of efficacy with a well-tolerated safety profile in pts with CLDN18.2-expressing resistant/refractory solid tumors, especially GC.
DOI:
10.1200/JCO.2023.41.16_suppl.3016
Trial ID:
Source:
Title:
First-in-human dose escalation and expansion study of SYSA1801, an antibody-drug conjugate targeting claudin 18.2 in patients with resistant/refractory solid tumors.
Published date:
05/25/2023
Excerpt:
SYSA1801 shows promising early signs of efficacy with a well-tolerated safety profile in pts with CLDN18.2-expressing resistant/refractory solid tumors, especially GC.
DOI:
10.1200/JCO.2023.41.16_suppl.3016
Trial ID:
Source:
Title:
Abstract ND11: EO-3021: An antibody drug conjugate targeting CLDN18.2 expressing cancers
Published date:
05/29/2023
Excerpt:
EO-3021 is internalized in claudin 18.2-expressing cells as well as demonstrates cell killing across a range of cancer cell lines with low (IC50 = 228 ng/ml), medium (IC50 = 7 ng/ml), and high levels of claudin 18.2 (IC50 = 28 ng/ml) expression...EO-3021 demonstrates tumor regressions with a single dose across low, medium, and high claudin 18.2-expressing in vivo models derived from pancreatic (9 mg/kg), gastric (2 mg/kg), and lung cancers (8 mg/kg), respectively.
DOI:
10.1158/1538-7445.AM2023-ND11
Title:
Elevation Oncology Presents EO-3021 Preclinical Proof-of-Concept Data and Highlights a Clinical Case Study in Claudin 18.2-Expressing Cancers at AACR 2023
Published date:
04/17/2023
Excerpt:
Elevation Oncology, Inc...presenting preclinical proof-of-concept data and highlighting a clinical case study in Claudin 18.2-expressing cancers for the company's lead candidate, EO-3021...EO-3021 demonstrated anti-tumor activity in preclinical xenograft models of pancreatic and gastric cancers expressing varying levels of Claudin 18.2.
Source:
Title:
Abstract 6300: Therapeutic potential of EO-3021/SYSA1801, a Claudin18.2 antibody-drug conjugate, for the treatment of CLDN18.2-expressing cancers
Published date:
04/04/2023
Excerpt:
EO-3021 demonstrated profound in vivo antitumor activity and outperformed SOC in gastric, pancreatic, and lung cancer models. Results from in vitro and in vivo studies highlight the promising therapeutic potential of EO-3021/SYSA1801 for patients with CLDN18.2-expressing cancers.
DOI:
10.1158/1538-7445.AM2023-6300
