Actuate 1801: Phase 1/2 of 9-ING-41 in Refractory Malignancies
Research type
Research Study
Full title
Actuate 1801: Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematological Malignancies or Solid Tumors.
IRAS ID
1007140
Contact name
Daniel Schmitt
Contact email
Sponsor organisation
Actuate Therapeutics, Inc
Eudract number
2018-003739-32
Clinicaltrials.gov Identifier
Research summary
This is a clinical trial, a type of research study, which involves giving patients an investigational drug called 9-ING-41, either by itself or together with standard anti-cancer drugs. Patients taking part in this study have cancer that has continued to grow despite the treatments they may have already received and/or have cancer that has spread to other parts of the body (metastatic disease). Either the standard drugs used to treat their disease are no longer working or there are no known treatments that work because the tumor cells may be resistant to these treatments, or they have not received any treatment for the metastatic disease.
9-ING-41 stops an enzyme called GSK-3β from working in cancer cells. GSK-3β helps cancer cells to grow and to become resistant to chemotherapy drugs. The purpose of this study is to see if by stopping the activity of GSK-3β using 9-ING-41, it may be possible for chemotherapy drugs to regain their effectiveness in treating cancers in patients where they have stopped being effective or are effective in only a minority of patients or if it will improve the effectiveness of standard chemotherapy drugs.
There are 3 parts to this study. Part 1 was to find out about the safety of 9-ING-41 when given as a single drug to patients and to determine what dose of 9-ING-41 would be tested in Part 2. In Part 2, 9-ING-41 was combined with chemotherapy drugs to find out about the safety of 9-ING-41 in these combinations. The choice of chemotherapy drug depended on what was given for the patient’s cancer in the past. Part 2 determined what dose of 9-ING-41 is safe to be combined with the chemotherapy drugs for testing in study Part 3. Part 3 will assess if the 9-ING-41-based combinations are effective in either reducing the amount of cancer that a patient has and/or if the combinations can stop or delay the cancer’s growth. In Part 3 Arm B, the effectiveness will be compared between 9-ING-41 with gemcitabine/nab-paclitaxel (GA) and GA alone.
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
23/NE/0108
Date of REC Opinion
17 Aug 2023
REC opinion
Further Information Favourable Opinion