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TTX-MC138

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |TransCode Therapeutics, Inc.|Last Updated: Oct 2, 2025

Target and mechanism

Molecular targetmicroRNA-10b
Target classMicrorna
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment16

FDA Designations

ORPHAN_DRUG

Clinical trial landscape

TTX-MC138 · 1 trial · 1 indication

Phase 1 1
NCT06260774Study of TTX-MC138 in Subjects With Advanced Solid TumorsAdvanced Solid Tumor
ACTIVE NOT_RECRUITING16 Analytics
PHASE1ACTIVE NOT_RECRUITING
Study of TTX-MC138 in Subjects With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Dose Escalation - Overall Response Rate (ORR)
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

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

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose level 1EXPERIMENTAL0.4 mg/kg of TTX-MC138
Dose level 2EXPERIMENTAL0.8 mg/kg of TTX-MC138
Dose level 3EXPERIMENTAL3.2 mg/kg of TTX-MC138

Interventions

NameTypeDescription
TTX-MC138DRUGThe 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.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: 1. 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. 2. Must have measurable or eva...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Frequently asked questions about TTX-MC138

What is TTX-MC138 used for?

TTX-MC138 is an investigational small molecule being developed for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in patients with advanced solid tumors who are at least 18 years old.

What does TTX-MC138 target?

TTX-MC138 targets microRNA-10b, a microRNA involved in cancer progression. By targeting this molecule, the drug aims to interfere with pathways that may contribute to tumor growth and spread. This mechanism is being evaluated in a Phase 1 clinical trial for advanced solid tumors.

Who is developing TTX-MC138?

TTX-MC138 is being developed by TransCode Therapeutics, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug in patients with advanced solid tumors. TransCode Therapeutics is publicly traded under the ticker symbol RNAZ.

What phase is TTX-MC138 in?

TTX-MC138 is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 1 trial is active but not recruiting participants, and it is designed to study the drug in patients with advanced solid tumors.

What clinical trials is TTX-MC138 in?

TTX-MC138 is being studied in a single Phase 1 clinical trial with the identifier NCT06260774. The trial, titled 'Study of TTX-MC138 in Subjects With Advanced Solid Tumors,' is active but not recruiting and has an enrollment of 16 participants. It is being conducted in the United States.

Has TTX-MC138 received FDA orphan drug designation?

Yes, TTX-MC138 has received orphan drug designation from the FDA. This designation is granted to drugs intended to treat rare diseases and may provide certain development incentives. The drug is still in Phase 1 clinical development and remains investigational.