Abstract 5353
Background
9-ING-41 is a first-in-class, intravenously (IV) administered, small molecule potent selective GSK-3β inhibitor with significant pre-clinical antitumor activity in a broad spectrum of malignancies, both as a single agent and in combination with cytotoxic agents. GSK-3β is a serine/threonine kinase important in tumor progression and modulation of oncogenes, cell cycle regulators and mediators of epithelial-mesenchymal transition. Aberrant overexpression of GSK-3β is associated with advanced stage and aggressive tumor growth as well as chemotherapy resistance.
Trial design
This Phase 1/2 study is designed to evaluate the safety and efficacy of 9-ING-41 as a single agent and in combination with cytotoxic agents, in patients with refractory cancers. Treatment consists of twice-weekly IV infusion of 9-ING-41 as a single agent (21-day-cycle) or combined with chemotherapeutic agents including gemcitabine, doxorubicin, lomustine, carboplatin, nab-paclitaxel, or paclitaxel. Study parts 1 and 2 will evaluate the safety and tolerability, describe any dose-limiting toxicity (DLT), determine the maximum tolerated dose (MTD) and the recommended Phase 2 study dose (RP2D) for 9-ING-41 as monotherapy (Part 1) and in combination with chemotherapies (Part 2). Part 3 (Simon 2-Stage Phase 2 at the RP2D) will assess clinical benefit in patients with relapsed or refractory malignancies treated with 9-ING-41-based combinations at the RP2D established in Part 2. Safety will be assessed by recording and monitoring adverse events (CTCAE). For solid tumors, response will be defined by response evaluation criteria in solid tumors (RECIST) 1.1 criteria in the evaluable lesion(s). For lymphoma, response will be assessed per the International Working Group Response Criteria. For CNS tumors, response will be followed by the RANO and the MacDonald criteria. The study is opening in 25 sites globally and will accrue approximately 250 patients.
Clinical trial identification
NCT03678883.
Editorial acknowledgement
Legal entity responsible for the study
Actuate Therapeutics Inc.
Funding
Actuate Therapeutics Inc.
Disclosure
B. Carneiro: Research grant / Funding (institution): Actuate Therapeutics Inc; Research grant / Funding (institution): Abbvie; Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Bayer. L. Cavalcante: Research grant / Funding (institution): Actuate Therapeutics Inc. P. Munster: Research grant / Funding (institution): Actuate Therapeutics Inc. F. Giles: Leadership role, Shareholder / Stockholder / Stock options, Full / Part-time employment: Actuate Therapeutics Inc. All other authors have declared no conflicts of interest.
Resources from the same session
4321 - Health-related quality of life of advanced melanoma survivors treated with CTLA-4 immune checkpoint inhibition: a matched cohort study
Presenter: Annelies Boekhout
Session: Poster Display session 1
Resources:
Abstract
779 - Capecitabine vs Cisplatin along with concurrent radiotherapy in the treatment of inoperable lower esophageal cancers focusing on TWISTT score and QOL
Presenter: Goutham Anugu
Session: Poster Display session 1
Resources:
Abstract
5914 - Cancer, Mental Health and End Life Simulation (CAMhELS): A novel effectiveness evaluation.
Presenter: Asanga Fernando
Session: Poster Display session 1
Resources:
Abstract
2597 - Cancer patients’ expectations and understanding about their disease
Presenter: Mónica Pinho
Session: Poster Display session 1
Resources:
Abstract
5187 - Impact of patients’ death on oncologists and coping strategies: An online survey
Presenter: Soumaya Labidi
Session: Poster Display session 1
Resources:
Abstract
4579 - Clinical benefit from late lines of therapy offered to patients treated in a tertiary referral centre
Presenter: Andrea Sbrana
Session: Poster Display session 1
Resources:
Abstract
5058 - Preparedness for caregiving in caregivers of cancer patients
Presenter: Hatice Yakar
Session: Poster Display session 1
Resources:
Abstract
5917 - Oncologic Emergency Medicine in the real world: A survey and proposal for improvement
Presenter: Carintia Dorta Pérez
Session: Poster Display session 1
Resources:
Abstract
4077 - The Reality of Critical Cancer Patients in a Polyvalent Intensive Care Unit
Presenter: Tiago Filipe Da Cruz Tomas
Session: Poster Display session 1
Resources:
Abstract
1728 - A phase III trial evaluating olanzapine 5 mg for the prevention of chemotherapy-induced nausea and vomiting in patients receiving cisplatin: J-FORCE Study
Presenter: Hironobu Hashimoto
Session: Poster Display session 1
Resources:
Abstract