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Actuate 1801: Phase 1/2 Study of Elraglusib (9-ING-41), a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined with Chemotherapy, in Patients with Refractory Hematologic Malignancies or Solid Tumors

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518409-16-00
Acronym
1801
Enrollment
225
Registered
2024-10-30
Start date
2021-04-14
Completion date
Unknown
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Hematologic Malignancies or Solid Tumors

Brief summary

1-year survival rate of patients treated on the Elraglusib schedule chosen from the run-in portion of the study compared to the control arm.

Detailed description

Disease control rate (DCR), defined as: Stable disease for ≥16 weeks, confirmed complete response, or confirmed partial response., Objective response rate (ORR), defined as the percent of patients with Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria relative to the efficacy population., Duration of Response (DOR), defined as the time from documentation of tumor response to disease progression, Progression-Free Survival (PFS), defined as the time from study enrolment until objective tumor progression or death, OS, defined as the time from study entry to death from any cause, Time to Treatment Failure (TTF), Adverse events will be monitored from the date of first administration of Elraglusib and ending 30 days after the final administration of Elraglusib using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0, Correlation of disease control rate with tumor molecular profiles

Interventions

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

Sponsors

Actuate Therapeutics Limited
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1-year survival rate of patients treated on the Elraglusib schedule chosen from the run-in portion of the study compared to the control arm.

Secondary

MeasureTime frame
Disease control rate (DCR), defined as: Stable disease for ≥16 weeks, confirmed complete response, or confirmed partial response., Objective response rate (ORR), defined as the percent of patients with Complete Response (CR) or Partial Response (PR) according to the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria relative to the efficacy population., Duration of Response (DOR), defined as the time from documentation of tumor response to disease progression, Progression-Free Survival (PFS), defined as the time from study enrolment until objective tumor progression or death, OS, defined as the time from study entry to death from any cause, Time to Treatment Failure (TTF), Adverse events will be monitored from the date of first administration of Elraglusib and ending 30 days after the final administration of Elraglusib using the Common Terminology Criteria for Adverse Events (CTCAE), v5.0, Correlation of disease control rate with tumor molecular profiles

Countries

Belgium, France, Portugal, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026