Evaluate Preliminary Anti-tumor Activity of Elraglusib in Adult Participants With Advanced Solid Tumors

NCT07714395 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Actuate 2601
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being done to test the safety of elraglusib when taken once a day and to assess:

• How the body processes the drug (pharmacokinetics)
• Assess potential effects of the drug on heart rhythm
• Find the highest daily dose that can be given without causing side effects

Conditions

Advanced Malignant Solid Tumor

Keywords

Phase 1/2; Elraglusib; Elraglusib Oral tablet; Solid Tumor; GSK3beta; Glycogen Synthase Kinase 3 Beta inhibitor; ATR/Chk1

Outcome Measures

Primary Outcomes (1)

• To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and dose-limiting toxicities (DLTs) of elraglusib tablets

  Dose escalation/de-escalation decisions and the MTD will be determined at the end of Cycle 1 (each cycle is 21/28days).

  Determined at the end of Cycle 1 (each cycle is 21/28days) for each dose group tested up to 24 moths.

Secondary Outcomes (11)

• Pharmacokinetic Assessment

  From date of first dose through completion of Initial 21-day cycle. (Assessed Cycle 1 Only-up to 28 days) for each dose cohort, up to 24 months.

• Pharmacokinetic Assessment

  From date of first dose through completion of Initial 21-day cycle. (Assessed Cycle 1 Only-up to 28 days) for each dose cohort, up to 24 months.

• Pharmacokinetic Assessment

  From date of first dose through completion of initial 21-day cycle. (Assessed Cycle 1 Only-up to 28 days) for each cohort, up to 24 months.

• Pharmacodynamic Assessment

  From Day 1 Dosing through completion of Day 21 of Cycle 1 only. (Assessed Cycle 1 only, up to 28-days) for each dose cohort up to 24 months.

• Pharmacodynamic Assessment

  From date of first dose through completion of Initial 21-day cycle. (Assessed Cycle 1 Only-up to 28 days) for each dose cohort, up to 24 months.

Other Outcomes (2)

• Exploratory Endpoint Evaluation

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first. Patient will be assessed up to 30 months or up to 12 months after patient receives last dose of study drug.

• Exploratory

  From date of randomization until the date of first documented progression, date of death from any cause, whichever came first, assessed up to 12 months after receiving their last dose of study drug.

Study Arms (1)

Elraglusib Monotherapy Dose escalation/de-escalation

EXPERIMENTAL

Elraglusib 250 mg tablets will be administered once daily with food in 21-day cycles. DG-1: 125mg (Days 1, 3, 5 of a 21 day cycle) DG1: (Starting Dose) 125 mg/QD for 21 days DG2: 250mg/QD for 21 days DG3: 500mg QD for 21 days DG4: 750mg/QD for 21 days, Dosing will continue until MTD or MED is identified. Any higher dose levels which are explored will not exceed 50% increment relative to the prior cohort rounded down to the nearest 250 mg dose (or 125 mg dose if necessary).

Drug: Elraglusib Oral Tablets

Interventions

Elraglusib Oral Tablets DRUG

Elraglusib Oral Tablet, 250 mg

Elraglusib Monotherapy Dose escalation/de-escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign a written informed consent and is willing and able to comply with the protocol requirements including scheduled visits, treatment plan, laboratory tests and other study procedures
• Age ≥ 18 years
• Has histologically or cytologically confirmed diagnosis of advanced metastatic or progressive solid tumor characterized by one or more of the following:
• Participant is intolerant of existing therapy(ies) known to provide clinical benefit for their condition
• Malignancy is refractory to existing therapy(ies) known to potentially provide clinical benefit
• Malignancy has relapsed after standard therapy
• Participant has contraindication to or declines standard therapies
• Has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, measured preferably by computed tomography (CT) scan or magnetic resonance image (MRI)
• Has laboratory function within specified parameters (may be repeated):
• Adequate bone marrow function: absolute neutrophil count (ANC) ≥ 1.5 x 109/L; hemoglobin ≥ 8.5 g/dL, platelets ≥ 100 x 103/μL
• Adequate liver function: transaminases (aspartate aminotransferase/ alanine aminotransferase, AST/ALT) and alkaline phosphatase ≤ 2.5 x upper limit of normal (ULN) or ≤ 5 x the ULN if liver metastases are present; total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN if elevations are due to underlying disease or concomitant medication/diseases
• Adequate renal function: BSA-adjusted glomerular filtration rate (GFR) ≥ 60 mL/min determined by multiplying estimated GFR by participant's body surface area (BSA) and dividing by 1.73
• Eastern Co-operative Oncology Group (ECOG) Performance Status (PS) ≤ 2
• Women of childbearing potential must have a negative baseline blood or urine pregnancy test within 72 hours of first dose of study drug. Women may be neither breastfeeding nor intending to become pregnant during study participation and must agree to use effective contraceptive methods (hormonal or barrier method of birth control, or true abstinence) for the duration of study participation and in the following 6 months after discontinuation of study treatment
• Male participants with partners of childbearing potential must take appropriate precautions to avoid fathering a child from screening until 6 months after discontinuation of study treatment and use appropriate barrier contraception or true abstinence

You may not qualify if:

• Participants who meet any of the following criteria will be excluded from the study:
• Pregnant or lactating
• Known to be hypersensitive to any of the components of elraglusib tablets or to the excipients used in its formulation
• Has not recovered from clinically significant toxicities as a result of prior anticancer therapy, except alopecia and/or infertility. Recovery is defined as ≤ Grade 2 severity per Common Terminology Criteria for Adverse Events (CTCAE), v6.0
• The following risk factors for abnormal heart rhythms/QT prolongation:
• A history of Torsade de pointes (TdP), other ventricular arrhythmias, or long QT syndrome
• A QT or QT interval corrected using Fridericia's formula (QTcF) \> 470 msec at Screening from triplicate ECGs
• Has significant cardiovascular impairment: congestive heart failure greater than New York Heart Association (NYHA) Class II, family history of long QT syndrome, unstable angina, or stroke within 6 months of the first dose of study therapy
• Has had a myocardial infarction within 6 months of the first dose of study therapy or has ECG abnormalities that are deemed medically relevant by the investigator
• Has symptomatic brain metastases or leptomeningeal involvement as assessed by CT scan or MRI. Participants with stable brain metastases or leptomeningeal disease are eligible provided they have not required new treatments for this disease in a 28-day period before the first dose of study drug, and anticonvulsants and steroids are at a stable dose for a period of 14 days prior to the first dose of study drug
• Has had major surgery within 14 days prior to study entry or is planned to have major surgery during the course of the study (major surgery may be defined as any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. In general, if a mesenchymal barrier is opened \[pleural cavity, peritoneum, meninges\], the surgery is considered major)
• Has any medical and/or social condition which, in the opinion of the Investigator or Medical Monitor would preclude study participation
• Previous anticancer therapies with any of the following:
• Small molecule ≤ 14 days or 5× the terminal phase elimination t1/2, whichever is shorter, prior to the first dose of study drug
• Cytotoxic chemotherapy ≤ 14 days prior to the first dose of study drug

Sponsors & Collaborators

• Actuate Therapeutics Inc.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There are two phases to this study: In Phase 1: To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and dose-limiting toxicities (DLTs) of elraglusib tablets In Phase 2: Determine the effect of elraglusib on different types of cancer determined based on the information from Phase 1.

Study Record Dates

• First Submitted: June 19, 2026
• First Posted: July 20, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share