Actuate1801

Primary Objectives
To evaluate the safety and tolerability, describe any dose-limiting toxicity (DLT), and determine the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) (in the absence of exceeding the MTD) for 9-ING-41 as monotherapy (Part 1) and in combination with chemotherapies (Part 2) in patients with relapsed or refractory malignancies and to assess clinical benefit in patients with advanced malignancies who are treated with 9-ING-41-based combinations (Part 3)

Voir la section 8.7 du protocole pour les détails de la partie Partie 3 bras B
LE CISSSMC ne participera qu’à la portion 3B de l’Étude en se concentrant sur le cancer du pancréas métastatique.

La toxicité des traitements actuels ne sont pas appropriés pour tous les patients d’ou l’urgence de trouver de meilleurs traitements pour cette population. This is an international, open label, multi-center Phase 1/2 study of 9-ING-41 as a single agent or when combined with chemotherapy in adult patients with recurrent or refractory advanced cancers. Treatment will consist of twice-weekly intravenous (IV) infusion of 9-ING-41 as a single agent or by infusion following standard chemotherapeutic agent(s) administration

By Amendment 4.0 Part 3 Arm B introduces a once weekly intravenous (IV) infusion along with the twice weekly schedule of 9-ING-41 following administration of standard chemotherapeutic agents for pancreatic cancer (gemcitabine plus nab-paclitaxel). By Amendment 5.0 Part 3 Arm B is being expanded to determine the 1-year survival rate of the better 9-ING-41 schedule (once or twice weekly).

Avec l’amendement 6
Pour la partie 3B, 9-ING-41 est donné par infusion pour 1 – 4 heures (selon la dose) une fois semaine. Les patients qui seront randomisés dans cette phase recevront:

o nab-paclitaxel plus gemcitabine (33% de chance) , OU
o nab-paclitaxel plus gemcitabine, plus 9-ING-41 (67% de chance)