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Solid Tumors (Phase 1)Phase 1NCT07874880

MTX-531-001 Phase 1 Study in Advanced Solid Tumors

A Phase 1 study testing MTX-531 in people with Solid Tumors (Phase 1) and HNSCC, run by MEKanistic Therapeutics, Inc. at 1 site in United States.

Not yet recruiting

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

Sites and contacts
Official record
Search all trials

Trial summary

This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess how the drug is… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors (Phase 1), HNSCC, Endometrial Cancer
What is being tested?
MTX-531
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteUnited States
Study dates
20 Oct 2026to 29 Sep 2029
Phase
Phase 1
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

  • Age
  • Age ≥18 years at the time of signing the informed consent.
  • Disease Characteristics
  • Has one of the following types of advanced or refractory solid tumor malignancy:
  • EC - No specific requirement
  • FIGO stage III or IV (unresectable, recurrent, or metastatic disease) at study entry
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  • Received 1, 2, or 3 prior systemic regimens in any setting that must include:
  • Anti-PD(L)1 in any setting (unless contraindicated) ii. A platinum-containing chemotherapy in any setting c. Adjuvant/neoadjuvant chemotherapy with or without additional anti-cancer therapy will not count as a prior regimen in the absence of recurrence during or within 6 months of completion of the last dose of planned therapy.
  • MBC - No specific requirement
  • Advanced or metastatic disease at the time of entry
  • HER2 negative according to American Society of Clinical Oncology/College of American Pathologists guidelines, defined as a HER2 IHC score of 0 or 1+, or an IHC score of 2+ accompanied by a negative fluorescence, chromogenic, or silver in situ hybridization test indicating the absence of HER2 gene amplification, or a HER2/CEP17 ratio of <2.0 based on the most recent tumor biopsy and assessed locally.
  • Refractory to or relapsed after at 2, 3, 4, or 5, prior systemic regimens for metastatic disease, including (unless contraindicated):
  • At least 1 cytotoxic chemotherapy regimen (as single agent or combination) in any setting.
  • At least 1 anticancer hormonal treatment in any setting. iii. At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting. iv. Other treatments (eg, antibody-drug conjugates, PI3K pathway inhibitors) are allowed as long as the number of prior lines of therapy is not exceeded.
  • Participants with bone-only metastases are excluded unless antitumor activity can be assessed using elevated baseline clinical tumor markers (eg, CA15-3, CA 27-29, CEA), or ctDNA.
  • HNSCC - No specific requirement
  • Recurrent, locally advanced or metastatic at time of entry b. Received 1, 2, 3, or 4 prior systemic regimens in any setting that must include: i. A platinum-based regimen in the relapse/metastatic setting ii. An anti-PD(L)1 in any setting.
  • Advanced or metastatic CRC Pan-RAS and BRAF wildtype in tumor and/or ctDNA
  • Advanced or metastatic disease at the time of entry
  • Received 1, 2, 3, or 4 prior systemic regimens for the treatment of advanced or metastatic CRC that must include the following (unless contraindicated):
  • Fluoropyrimidine ii. Irinotecan iii. Oxaliplatin iv. Biologic therapy (including but not limited to approved anti-VEGF, anti VEGFR or anti-EGFR monoclonal antibodies) v. Targeted therapy or immunotherapy if appropriate c. Adjuvant/neoadjuvant chemotherapy with or without additional anti-cancer therapy will not count as a prior regimen in the absence of recurrence during or within 6 months of completion of the last dose of planned therapy.
  • Other solid tumors
  • PIK3CA in tumor and/or ctDNA
  • Other solid tumors, excluding primary CNS tumor
  • At least 1 prior line of systemic anti-cancer therapy and no other standard therapeutic options.
  • Tumor mutation status using a validated method such as FoundationOne®CDx must be known before enrollment. Locally available testing may also be acceptable upon discussion with the Medical Monitor.
  • Has the ability to swallow and has a functional gastrointestinal tract.
  • ECOG performance status score of 0, 1, or 2.
  • Measurable disease by RECIST 1.1. If no measurable disease by RECIST 1.1, discuss with Medical Monitor the availability of other suitable tumor markers for assessments for antitumor activity.
  • Baseline oxygen saturation on room air ≥92%.
  • LVEF >50% as per echocardiography or multi-gated acquisition scan.
  • Baseline QTc interval ≤470 msec using Fridericia's QT correction formula. Note: This criterion does not apply to participants with right or left bundle branch block or on pacemakers, but prior discussion with the Medical Monitor is required.
  • Clinical Laboratory Values
  • HbA1c <8.0%.
  • Adequate organ function, defined as follows:
  • Bone Marrow
  • Platelets ≥100,000/mm3
  • Hemoglobin ≥9.0 g/dL (can be transfused within 7 days but cannot be transfusion dependent)
  • WBC >3000/mm3
  • ANC >1500/mm3
  • Liver Function
  • Total bilirubin ≤1.5 × ULN
  • AST ≤2.5 × ULN; ALT ≤2.5 × ULN (AST, ALT ≤5 × ULN if liver metastases are present)
  • Coagulation
  • INR ≤1.5; aPTT ≤1.5 × ULN in the absence of anticoagulant therapy or within acceptable parameters per local standard of care on anticoagulant therapy.
  • Renal Function
  • Creatinine clearance ≥60 mL/min either measured or calculated using standard Cockcroft-Gault formula.
  • Albumin ≥3.0 g/dL
  • Prior Therapy
  • Recovered to ≤Grade 1 toxicity from previous therapies, excluding alopecia, peripheral neuropathy, lymphopenia or therapy-related hypothyroidism or other endocrine disorders that are well controlled.
  • Demonstrated progressive disease or intolerance to the last regimen. Sex and Contraceptive/Barrier Requirements
  • Contraceptive use by participants should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Male Participants:
  • Participants are eligible to participate if they agree to the following during the study intervention period and for at least 180 days after the last dose of study intervention:
  • Refrain from donating sperm
  • PLUS, either:
  • Be abstinent from intercourse where pregnancy can occur (abstinent on a long term and persistent basis) and agree to remain abstinent
  • OR
  • Must agree to use [contraception /barrier] as detailed below: Agree to use an external condom and with child-bearing potential (CBP) partner use an additional highly effective contraceptive method with a failure rate of <1% per year as described in Section 10.4 when having sexual intercourse with a partner able to give birth who is not currently pregnant.
  • Female Participants:
  • A participant is eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies:
  • Is not of CBP.
  • OR
  • Is of CBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency, as described in Section 10.4, during the study intervention period and for at least 90 days after the last dose of study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The Investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention.
  • A CBP participant must have a negative highly sensitive pregnancy test (urine or serum, as required by local regulations) during screening and before the first dose of study intervention Day 1 of Cycle 1; see Section 8.3.5.
  • Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.5.
  • The Investigator is responsible for review of medical history, menstrual history, and recent sexual activity where pregnancy can occur to decrease the risk for inclusion of a participant with an early undetected pregnancy.
  • Informed Consent
  • Signed informed consent as described in Section 10.1.2, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Other Inclusion Criteria
  • Has a new or recent tumor biopsy (collected at screening, if feasible) or archived specimen within 5 years prior to screening.

Who cannot join

  • Medical Conditions
  • History (within 2 years before screening) of a malignancy that is histologically distinct from the cancers being studied with the exception of adequately treated basal cell or squamous cell skin cancers and/or ductal carcinoma in situ of the breast or other malignancies that have a very low potential for recurrence or for confounding study results.
  • Symptomatic brain metastases requiring steroids or other interventions. Participants with previously diagnosed brain metastases are eligible if treatment has been completed and the participant has recovered from the acute effects of radiation therapy or surgery prior to study entry, have discontinued corticosteroid treatment for these metastases for at least 2 weeks before the first dose of MTX-531, and are neurologically stable.
  • Known leptomeningeal metastases.
  • Concurrent congestive heart failure, prior history of class III/ IV cardiac disease (New York Heart Association), myocardial infarction within the last 6 months, unstable arrhythmias, unstable angina or other poorly controlled cardiac conditions (eg, arrhythmias) that are considered significant by the Investigator.
  • Poorly controlled diabetes mellitus (including prior HbA1c measurements or compliance).
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  • Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection requiring IV antibiotics.
  • Experienced prior Grade 3-4 toxicities or severe toxicities from PI3K or EGFR inhibitors.
  • Any other medical condition (eg, pulmonary, psychiatric, neurological, significant dermatologic conditions that may confound the interpretation of on-treatment toxicities or life-threatening toxicities from prior PI3K- or EGFR-directed therapies, if applicable) that in the opinion of the Investigator would place the participant at unacceptably high risk for toxicity.
  • Prior/Concomitant Therapy
  • Received systemic or local anticancer therapy within 3 weeks before the first dose of MTX-531 or 5 half-lives of the drug (whichever is less).
  • Received radiotherapy within 2 weeks before the first dose of MTX-531 and has not recovered from all radiation-related toxicities. A 1-week washout is allowed for palliative radiation (≤2 weeks of treatment course) to non-CNS tumors. Inability to swallow oral medications or impaired gastrointestinal absorption due to anomalies of the gastrointestinal tract, such as gastrectomy or active inflammatory bowel disease.(Administration of oral medications via feeding tubes is not allowed.)
  • Any condition requiring chronic administration of >10 mg daily prednisone or equivalent or other immunomodulators.
  • Unable or unwilling to discontinue prohibited concomitant medications or adhere to restrictions for use of concomitant medications as defined in the protocol (see Section 6.9.2).
  • Other Exclusion Criteria
  • Pregnant or nursing women

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

    Holland Orndorff Clinical Research Coordinator, 949-764-7110, holland.orndorff@hoag.org

    Patrice Jones Clinical Research Manager, (949) 764-5501, Patrice.Jones@hoag.org

Other trials in United States

About this study

Official title: First-in-Human, Phase 1, Open-label Study to Evaluate the Safety, Clinical Activity, Pharmacokinetics, and Pharmacodynamics of MTX-531, a Dual EGFR/PI3K Inhibitor, as Monotherapy in Adults With Advanced Solid Tumors

This is a first-in-human, Phase 1, open-label study evaluating MTX-531, an investigational dual EGFR/PI3K inhibitor, in adults with advanced solid tumors. The study will evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess how the drug is processed by the body and its preliminary anti-tumor activity.

Read the detailed description

This first-in-human, Phase 1, open-label study will evaluate MTX-531, an investigational small-molecule inhibitor of EGFR and PI3K, as monotherapy in adults with advanced solid tumors.

The study will evaluate the safety and tolerability of MTX-531 and determine the maximum tolerated dose (MTD) and provisional recommended Phase 2 dose (RP2D). The study will also characterize the pharmacokinetic (PK) profile of MTX-531 and evaluate its preliminary clinical activity.

Safety assessments will include adverse events, dose-limiting toxicities, laboratory assessments, vital signs, and electrocardiograms. Pharmacokinetic assessments will evaluate plasma concentrations and other PK parameters of MTX-531. Anti-tumor activity will be assessed through radiographic tumor evaluations and investigator-assessed response according to RECIST version 1.1.

This study represents the first clinical study of MTX-531.

Being tested
MTX-531
Keywords
Solid Tumors, HNSCC, Endometrial Cancer, Her2-negative metastatic breast cancer, Pan-RAS, BRAF wild-type advanced, Metastatic Colorectal Cancer (CRC), First-in-human, Phase 1 Solid Tumor, Phase 1, MTX-531, head and neck squamous cell carcinoma
Medical subject headings
Squamous Cell Carcinoma of Head and Neck, Endometrial Neoplasms, Colorectal Neoplasms

What participants receive

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

  • MTX-531Drug

    MTX-531 is an investigational small-molecule dual EGFR/PI3K inhibitor administered as monotherapy in adults with advanced solid tumors. Dose levels will be evaluated during dose escalation to assess safety, tolerability, pharmacokinetics, and preliminary clinical activity.

Study groups in NCT07874880
Study groupRoleWhat they receive
MTX-531 MonotherapyExperimentalParticipants receive MTX-531 as monotherapy in sequential dose levels to evaluate the safety and tolerability of MTX-531, determine the maximum tolerated dose and recommended Phase 2 dose, and assess pharmacokinetics and preliminary clinical activity.
Receives: Drug: MTX-531

What is being measured

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

  1. Safety and Tolerability profile of MTX-531

    To characterize the safety and tolerability profile of MTX-531 and to determine the MTD in participants with select advanced solid tumors.

    Measured: From the time of first dose of study drug administration up to 21 days.

  2. Provisional RP2D For Further Evaluation of MTX-531

    To determine the provisional RP2D for further evaluation of MTX-531

    Measured: From the time of first dose of study drug administration to 30 days after the last dose

Secondary outcomes (2)

  1. Evaluation of the Preliminary Clinical Activity of MTX-531

    To evaluate the preliminary clinical activity of MTX-531 as assessed by the Investigator

    Measured: Up to 30 days after the last dose

  2. Assessment of MTX-531's PK Profile

    To assess the PK profile of MTX-531

    Measured: Up to the end of the last study drug administration

Timeline

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

  1. First posted15 Oct 2026
  2. Study start20 Oct 2026 (estimated)
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion29 Sep 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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Participants receive MTX-531 as monotherapy in sequential dose levels to evaluate safety, tolerability, pharmacokinetics, and preliminary clinical activity.
Masking
None (open label)
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07874880
Sponsor's protocol ID
MTX-531-001
Status last verified
Oct 2026
First submitted
7 Oct 2026
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MTX-531 in people with Solid Tumors (Phase 1) and HNSCC, run by MEKanistic Therapeutics, Inc. at 1 site in United States.

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 71 inclusion and 16 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 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability profile of MTX-531 (time frame: From the time of first dose of study drug administration up to 21 days.). The study lists 2 primary outcomes in all. 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 NCT07874880.

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 15 Oct 2026.

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