Health TrialsbyHealthPanel

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

ConditionAdvanced Malignant Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorActuate Therapeutics Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

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

A history of Torsade de pointes (TdP), other ventricular arrhythmias, or long QT syndrome

Trial design

Design model

Sequential

Treatments tested in this trial

  • Elraglusib Oral Tablets

    Drug

    Elraglusib Oral Tablet, 250 mg

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Elraglusib Monotherapy Dose escalation/de-escalationExperimental treatment 1 intervention

Trial outcomes

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).

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

Secondary outcomes

1

Pharmacokinetic Assessment

Characterize Elraglusib Cmax

Time frame
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

Time frame
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).

Time frame
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).

Time frame
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.

Other outcomes

1

Exploratory Endpoint Evaluation

Progression-free survival (PFS) \[Phase 1 only\]

Time frame
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.
2

Exploratory

Overall survival (OS) (Phase 1 Only)

Time frame
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.

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Actuate Therapeutics Inc.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: