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Advanced Malignant Solid TumorPhase 1/2NCT07714395

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

A Phase 1/2 study testing Elraglusib Oral Tablets in people with Advanced Malignant Solid Tumor, run by Actuate Therapeutics Inc..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Malignant Solid Tumor
What is being tested?
Elraglusib Oral Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Oct 2026to Dec 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria to be eligible for inclusion in the study:
  • 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
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  • 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
  • Must not be receiving any other investigational medicinal product

Who cannot join

  • 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
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  • 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
  • Treatment with biologics (e.g., monoclonal antibodies, bispecific antibodies, cancer vaccines) ≤14 days prior to the first dose of study drug
  • Broad field radiation therapy ≤14 days prior to the first dose of study drug
  • Focal radiation therapy (including palliative) ≤ 7 days prior to the first dose of study drug
  • Systemic and topical corticosteroids ≤ 7 days prior to the first dose of study drug
  • Use of sensitive substrates of CYP3A4 with a narrow therapeutic from 14 days prior to first administration of study drug, during the study, and until Safety Follow-up Visit.
  • Use of strong inhibitors or inducers of CYP2C19, CYP1A2 and CYP3A4 from 14 days prior to first administration of study drug, during the study, and until Safety Follow-up Visit.
  • Use of inhibitors or inducers of major drug transporters (i.e., OATP1B1, OATP1B3, OCT1, OCT2 and MATE1/2K) from 14 days prior to first administration of study drug, during the study, and until the Safety Follow-up Visit.
  • Concomitant participation in another clinical study with study drug(s) or device
  • Unable to swallow a tablet or has any condition(s) that, in the opinion of the treating investigator, may affect gastrointestinal absorption
  • Considered to be a member of a vulnerable population (for example, prisoners)

About this study

Official title: Phase 1/2 Open-Label, Dose Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Anti-Tumor Activity of Elraglusib Oral Tablets in Adult Participants With Advanced Solid Tumors.

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
Read the detailed description

The study is a Phase 1/2, open label, dose escalation, safety, PK, PD and antitumor activity study of elraglusib tablets in participants aged 18 years or older with a histologically or cytologically confirmed diagnosis of advanced metastatic or progressive malignant solid tumors who are intolerant of or the malignancy is refractory to established therapy know to provide clinical benefit for their condition, or the malignancy has relapsed after standard therapy. Participants must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measured by computed tomography (CT) scan or MRI to be eligible.

The study's primary objective is to determine the MTD or MAD and DLTs of elraglusib tablets administered daily. The secondary objectives are to study the PK of elraglusib tablets, to evaluate preliminary antitumor activity of elraglusib when administered as tablets, and to establish the RDEs of elraglusib tablets in subsequent development.

Being tested
Elraglusib Oral Tablets
Keywords
Phase 1/2, Elraglusib, Elraglusib Oral tablet, Solid Tumor, GSK3beta, Glycogen Synthase Kinase 3 Beta inhibitor, ATR/Chk1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Elraglusib Oral TabletsDrug

    Elraglusib Oral Tablet, 250 mg

Study groups in NCT07714395
Study groupRoleWhat they receive
Elraglusib Monotherapy Dose escalation/de-escalationExperimentalElraglusib 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).
Receives: Drug: Elraglusib Oral Tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (11)

  1. Pharmacokinetic Assessment

    Characterize Elraglusib Cmax

    Measured: 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.

  2. Pharmacokinetic Assessment

    Characterize Tmax

    Measured: 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.

  3. Pharmacokinetic Assessment

    Assessment of half-life (t1/2), area under the plasma concentration-time curve from time 0 to time t (AUC0→t).

    Measured: 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.

  4. Pharmacodynamic Assessment

    Assess peripheral blood mononuclear cells (PBMCs, both cryopreserved and flash frozen).

    Measured: 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.

  5. Pharmacodynamic Assessment

    Plasma will be collected to analyze cfDNA.

    Measured: 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.

  6. Pharmacodynamic Assessment

    Plasma will be collected to analyze cytokines/chemokines.

    Measured: 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.

  7. Tumor Assessments

    Tumor response based on assessment of target and non-target lesions according to response evaluation criteria in solid tumors (RECIST) criteria.

    Measured: Baseline and per standard of care every 9 (±1) weeks during treatment and during follow-up through disease progression for unto 30 months.

  8. Electrocardiogram (ECG)

    Electrocardiograms will be collected to assess cardiac repolarization (QT) interval.

    Measured: Participation will be from Date of Screening through completion of the End of Treatment Visit, (EoT Visit), for up to 30 months. (Phase 1 Only)

  9. Electrocardiogram (ECG)

    Assessment of cardiac repolarization (QTc) interval.

    Measured: Participation will be from Date of Screening through completion of the End of Treatment Visit, (EoT Visit), for up to 30 months. (Phase 1 Only)

  10. Safety Assessments

    Frequencies and severities of adverse events (AEs)/TEAEs, including DLTs, serious adverse events (SAEs), and laboratory abnormalities that occur in Cycle 1 as well as in later treatment cycles will be assessed for all patients.

    Measured: From date of randomization until 30 days after receiving their last dose of study drug/completion of the End of Treatment Visit for up to 30 months.

  11. Number of participants with clinically significant changes in laboratory parameters, vital signs, and physical examinations.

    Blood and urine samples will be collected for analysis of lab parameters. Vital signs, physical examinations and organ-specific parameters will be collected at specified time points

    Measured: Participants will be tracked from Date of first dose through completion of end of study/Treatment visit for up to 30 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Model description
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.
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07714395
Sponsor's protocol ID
Actuate 2601
Status last verified
Jul 2026
First submitted
19 Jun 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Elraglusib Oral Tablets in people with Advanced Malignant Solid Tumor, run by Actuate Therapeutics Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and dose-limiting toxicities (DLTs) of elraglusib tablets (time frame: Determined at the end of Cycle 1 (each cycle is 21/28days) for each dose group tested up to 24 moths.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07714395.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2026.

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