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Association details:
| Biomarker: | PIK3CA mutation |
|---|---|
| Cancer: | Ovarian Cancer |
| Drug: | risovalisib (CYH33) (PIK3CA inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Study of CYH33 in Combination With Olaparib an Oral PARP Inhibitor in Patients With Advanced Solid Tumors.
Excerpt:
...- Cohort 2: Advanced solid tumors with PIK3CA hotspot mutation...
Trial ID:
Source:
Title:
A Study to Evaluate the Efficacy and Safety of CYH33 in Patients With Recurrent/Persistent Ovary Clear Cell Carcinoma
Excerpt:
...Tumor ORR per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 in patients with PIK3CA hotspot mutations.`...
Trial ID:
Less C2 evidence
Source:
Title:
First-in-human phase Ia study of the PI3Kα inhibitor CYH33 in patients with solid tumors
Published date:
11/16/2022
Excerpt:
Twenty-eight out of 42 evaluable patients had PIK3CA mutations, among whom the confirmed ORR was 14.3% (4/28) with a confirmed response observed in patients with breast cancer (2/5, 40%) and ovarian cancer (2/5, 40%), and a DCR of 46.4% (13/28).
DOI:
10.1038/s41467-022-34782-9
Trial ID:
Source:
Title:
A first-in-human phase I study of CYH33, a phosphatidylinositol 3-kinase (PI3K) a selective inhibitor, in patients with advanced solid tumors.
Published date:
05/28/2020
Excerpt:
... among 15 tumor response evaluable pts, partial response (PR) was observed in...1 breast cancer with PIK3CA mutant), and stable disease (SD) was observed in 3 pts with unknown PIK3CA mutation status. After the cut-off date, 1 more pt (ovarian cancer with PIK3CA mutation) treated with 40mg achieved PR...CYH33 demonstrated a manageable safety profile, linear PK, and encouraging preliminary anti-tumor activity.
DOI:
10.1200/JCO.2020.38.15_suppl.e15645
Trial ID:
