RE: Beijiing Cancer Hospital Write up28 Feb 2025 16:41
Https://www-bjcancer-org.translate.goog/Html/News/Articles/20332.html?_x_tr_sl=auto&_x_tr_tl=en
AVA6000 results in clinically meaningful tumor reduction in FAP-positive salivary gland cancer
vacta Therapeutics announced that AVA6000 showed clinically meaningful tumor reduction in fibroblast activation protein-Ξ± (FAP)-positive salivary gland cancer, with a disease control rate of 90% in the trial cohort. The Phase Ia trial showed good safety, reducing severe hematological and cardiac toxicity compared with conventional doxorubicin. (From Avacta Therapeutics)
"Salivary gland cancer is a devastating disease with no established standard of care. AVA6000 demonstrated clinically meaningful tumor reduction in salivary gland cancer, highlighting its potential as an important new treatment option for patients with salivary gland cancer and other solid tumors."
In order to continue to explore the potential of AVA6000 in patients with fewer lines of treatment and to address unmet medical needs in these disease settings, this Phase I study enrolled patients with FAP-positive salivary gland cancer and administered the investigational peptide-drug conjugate AVA6000 loaded with doxorubicin.
Eligibility criteria for Phase Ia: Age β₯ 18 years; patients with FAP-positive, histologically or cytologically confirmed, locally advanced (unresectable) and/or metastatic tumors, including salivary gland cancer, urothelial carcinoma, ovarian cancer , or breast cancer , which have recurred or progressed under standard treatment or are intolerant to standard treatment; patients with soft tissue sarcoma who have received first-time treatment in a locally advanced (unresectable) or metastatic setting , and patients who have received first-time anthracycline treatment in any setting, will be candidates for doxorubicin treatment.
In the Phase Ia dose-escalation phase, Group 1 received AVA6000 every 3 weeks and Group 2 received it every 2 weeks. The maximum tolerated dose for either group has not yet been determined.
Phase Ia results showed that after receiving AVA6000 at a dose of β₯250 mg/m 2 , 5 of 10 patients experienced tumor reduction, 1 of whom achieved a confirmed partial response (PR; tumor reduction of 45%) and 4 achieved a mild response (MR; tumor reduction of 10% to 19.5%). At 12 weeks, one patient with a confirmed PR still had a sustained response, but the patient stopped AVA6000 treatment after reaching the maximum exposure dose of doxorubicin. One patient with MR experienced rapid and complete regression of large-area skin and visceral metastases, but only low to moderate levels of FAP expression were found in his cancer-associated fibroblasts.
... etc (details from 16 Jan RNS: Avacta Announces Positive New Data from the AVA6000 Phase 1 trial Demonstrating Clinically Meaningful Tumor Shrinkage in Patients with Salivary Gland Cancers)