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TTX-MC138

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment16
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06260774Study of TTX-MC138 in Subjects With Advanced Solid TumorsPHASE1 ACTIVE NOT_RECRUITING 16Sep 5, 2024Feb 1, 2027Oct 2, 20254 United States
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06260774primaryCompletionDate: changed
LOWMay 24, 2026NCT06260774studyFirstPostDate: changed