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Advanced Solid TumorPhase 1/2NCT06260774

Study of TTX-MC138 in Subjects With Advanced Solid Tumors

A Phase 1/2 study testing TTX-MC138 in people with Advanced Solid Tumor, run by TransCode Therapeutics at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
TTX-MC138
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
4 sitesUnited States
Study dates
5 Sep 2024to 1 Feb 2027
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Have histologically or cytologically confirmed diagnosis of relapsed/refractory metastatic or locally advanced solid tumor where no standard therapy exists, standard therapy has failed and have no available therapies with known clinical benefit.
  • Must have measurable or evaluable disease per RECIST version 1.1.
  • ≥18 years at the time of informed consent.
  • Life expectancy of ≥3 months
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
  • Have adequate organ function defined as:
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  • Platelet count ≥75×109/L with no platelet transfusions in the past 7 days
  • Absolute neutrophil count ≥1.0×109/L
  • Hemoglobin ≥8 g/dL (red blood cell transfusion may be used to reach 8 g/dL but must have been administered at least 1 week prior to the administration of the study drug)
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) <2.5× the upper limit of normal (ULN) if no hepatic metastases are present; <5× ULN if hepatic metastases are present
  • Total bilirubin <1.5× ULN; <3 X ULN in the presence of Gilbert's disease
  • Estimated (Cockcroft-Gault formula) or measured creatinine clearance ≥60 mL/min
  • International normalized ratio (INR) ≤1.5× ULN unless participant is receiving anticoagulant therapy as long as the prothrombin time (PT) or activated partial thromboplastin time (aPTT) is within therapeutic range of intended use of anticoagulants
  • If female of childbearing potential, either abstain from sexual intercourse or employ highly effective contraception measures during the study and for ≥30 days after the administration of the study drug. Highly effective measures include 2 forms of contraception. Postmenopausal or surgically sterile women (ie, hysterectomy, bilateral salpingectomy, and bilateral oophorectomy) are eligible. Postmenopausal status is defined as either: amenorrheic for ≥12 months following cessation of exogenous hormonal treatments and without an alternative medical cause; luteinizing hormone and follicle-stimulating hormone levels in the postmenopausal range for women <50 years of age; radiation-induced ovarian ablation with last menses ≥1 year ago; or chemotherapy-induced menopause with a ≥1-year interval since last menses. Female subjects must refrain from donating or banking eggs (ova, oocytes) and retrieving eggs for use during study treatment and for 30 days after the administration of the study drug.
  • For male subjects not surgically sterile, must either abstain from sexual intercourse or employ highly effective contraception (condoms or other barrier forms of contraception) during the study and for at least 30 days after the administration of the study drug. Male subjects should also avoid semen donation or providing semen for in vitro fertilization during the above-mentioned duration.
  • Able to understand and willing to provide informed consent and able to comply with the study procedures, including biopsy, and restrictions.

Who cannot join

  • Unwilling or unable to comply with scheduled visits, study drug administration plan, laboratory tests, or other study procedures and study restrictions.
  • Have received anticancer therapy (including both systemic therapy and radiotherapy, but not including immunotherapy or other antibody therapies) within 14 days or 5 half-lives (whichever is shorter) of study drug administration or;
  • received antibody therapy within 30 days before the start of study drug administration.
  • Have a history of a second primary malignancy that has been diagnosed or required active therapy within the past year.
  • Note: The following prior malignancies are not exclusionary: completely resected basal cell and squamous cell skin cancer, curatively treated localized prostate or breast cancer, curatively treated localized thyroid cancer, and completely resected carcinoma in situ of any site.
  • Have central nervous system (CNS) metastases or primary CNS tumor that is associated with progressive neurologic symptoms or requires ongoing corticosteroids to control the CNS disease. Subjects must have a stable neurologic status without steroid support for ≥2 weeks before the start of study drug administration. Subjects with stable or asymptomatic CNS metastases or primary CNS are eligible.
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  • Require treatment with traditional/herbal medicines or their preparations indicated for tumors or with adjuvant anti-tumor effects that cannot be discontinued during the study.
  • Have clinically significant, uncontrolled cardiovascular disease including congestive heart failure Class III or Class IV according to the New York Heart Association classification; myocardial infarction or unstable angina within the previous 6 months; uncontrolled hypertension (Grade ≥3); or clinically significant, uncontrolled arrhythmia, including bradyarrhythmia that may cause QT prolongation (eg, Type II second-degree heart block or third-degree heart block).
  • Have QT interval corrected using Fridericia's formula >480 msec. Unless the subject has a history of prolonged QT syndrome or torsade de pointes or a familial history of prolonged QT syndrome.
  • Have a history of acute ischemic stroke, diagnosed by imaging (CT or MRI) or clinical diagnosis within 6 months prior to screening.
  • Have any severe or uncontrolled systemic disease or condition per clinical judgement, including: (i) uncontrolled hypertension or diabetes; (ii) serious cardiac, pulmonary, or renal conditions; (iii) active bleeding diatheses; (iv) any active type of bacterial, viral, fungal, or other infection that would pose a significant risk to the subject in the opinion of the Investigator; (v) cerebrovascular accident within the last 6 months before administration of study drug.
  • Have received a major surgical procedure within 28 days before the start of study drug administration (procedures such as central venous catheter placement and tumor needle biopsy are not considered major surgical procedures). The study center should discuss other minor surgeries with the sponsor.
  • Clinical diagnosis of hemochromatosis or secondary iron overload,
  • Have known human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection that is not well-controlled and meets any of the following exclusion criteria:
  • Documented detectable HIV RNA within 4 weeks of study drug administration,
  • Acquired immunodeficiency syndrome defining opportunistic infections within the past 12 months prior to study enrollment, and
  • Is not on antiretroviral therapy for at least 4 weeks prior to study enrollment.
  • Have clinical signs or symptoms consistent with COVID-19 infection or confirmed infection by appropriate laboratory test (done at the discretion of Investigator or per local regulation) within the last 2 weeks before the administration of the study drug. In case of confirmed COVID-19 infection before screening, documentation of resolution of infection by appropriate laboratory test is required.
  • Have received or are planning to receive a COVID-19 vaccination within 2 weeks before or after the administration of the study drug. However, COVID-19 vaccinations received >2 weeks before or after the administration of the study drug are permitted.
  • Have received a live or live attenuated vaccines within 30 days before the administration of the study drug.
  • Have any unresolved clinically relevant toxicities from prior therapy, greater than NCI CTCAE Grade 1 at the time of starting study treatment, except for alopecia.
  • Have a history of hypersensitivity to active or inactive excipients of the study drug or drugs with a similar chemical structure or class to the study drug, including ferumoxytol (Feraheme®).
  • Have an active autoimmune disease (eg, rheumatoid arthritis, systemic lupus erythematosus, ulcerative colitis, Crohn's disease, multiple sclerosis, ankylosing spondylitis, thyroiditis) requiring continuing immune suppressive therapy, including >10 mg prednisone per day or equivalent.
  • Pregnant or breastfeeding at the time of screening or on Day 1 before TTX-MC138 as documented by a serum beta human chorionic gonadotropin pregnancy test consistent with pregnancy.
  • Known current drug or alcohol abuse.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Mary Crowley Cancer Center

    Dallas, Texas, 75230

  • Next Oncology

    Fairfax, Virginia, 22031

  • MD Anderson Cancer Center

    Houston, Texas, 77230

  • START Mountain Region

    West Valley City, Utah, 84119

Other trials in United States

About this study

Official title: A Phase 1/2 Multicenter, Open-Label, Dose-escalation and Expansion Study of TTX-MC138 in Subjects With Advanced Solid Tumors

A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors

Read the detailed description

The study will consist of 2 phases, dose escalation and dose expansion, with 3 study periods: Screening (up to 28 days), Treatment (28-day treatment cycles, with dosing on Day 1), and Survival Follow-up (every 3 months). Each 28-day cycle is comprised of 1 dose of study drug administered as an intravenous (IV) infusion on Day 1.

A subject will continue on treatment until a dose limiting toxicity (DLT) is observed, other adverse event (AE) leading to unacceptable toxicity as assessed by the Investigator, progression of disease, or withdrawal of consent.

Being tested
TTX-MC138

What participants receive

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

  • TTX-MC138Drug

    The starting dose of TTX-MC138 in the first cohort will be 0.4 mg/kg and will be increased incrementally in subsequent cohorts until maximum tolerated dose (MTD) determination.

Study groups in NCT06260774
Study groupRoleWhat they receive
Dose level 1Experimental0.4 mg/kg of TTX-MC138
Receives: Drug: TTX-MC138
Dose level 2Experimental0.8 mg/kg of TTX-MC138
Receives: Drug: TTX-MC138
Dose level 3Experimental3.2 mg/kg of TTX-MC138
Receives: Drug: TTX-MC138

What is being measured

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

  1. Dose Escalation - Adverse Events

    The safety and tolerability of escalating dose levels of TTX-MC138 to determine incidence of treatment-emergent adverse events (TEAEs).

    Measured: Throughout study treatment for 18 subjects, for average of 3 months and post treatment for survival follow-up through study completion, an average of 1 year

  2. Dose Escalation - Overall Response Rate (ORR)

    proportion of subjects with a best response of CR, PR, or stable disease for at least 8 weeks per RECIST version 1.1.

    Measured: Throughout study treatment for 18 subjects, for average of 3 months and post treatment for survival follow-up through study completion, an average of 1 year

Timeline

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

  1. First posted15 Feb 2024
  2. Study start5 Sep 2024
  3. Primary completion30 Sep 2025
  4. Study completion1 Feb 2027 (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
Non-randomised
Intervention model
Sequential
Model description
Dose Escalation Study Design
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06260774
Sponsor's protocol ID
TTX-MC138-002
Other IDs
1R44CA295173-01
Status last verified
Oct 2025
First submitted
12 Dec 2023
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TTX-MC138 in people with Advanced Solid Tumor, run by TransCode Therapeutics at 4 sites 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 16 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: under way, not looking for participants, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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 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?

Dose Escalation - Adverse Events (time frame: Throughout study treatment for 18 subjects, for average of 3 months and post treatment for survival follow-up through study completion, an average of 1 year). 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 NCT06260774.

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 2 Oct 2025.

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