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TT-10

Phase 1

Renal Cell Cancer | Small molecule | Oncology |AlphaTON Capital Corp.|Last Updated: Apr 2, 2025

Success Probability
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Market & Valuation
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Trial Design
CONTROLLEDBiomarker
Total Trials1
Total Enrollment90
FDA Designations
No designations recorded
Clinical trial landscape

TT-10 · 1 trial · 7 indications

Phase 1 1
NCT04969315TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid TumorsRenal Cell Cancer
RECRUITING90 Analytics
PHASE1RECRUITING
TT-10 (PORT-6) and TT-4 (PORT-7) as Single Agents and in Combination in Subjects With Advanced Selected Solid Tumors
Renal Cell Cancer
NCT0496931590
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Study Endpoints
Primary Endpoints
Number of subjects with Dose Limiting Toxicities (DLTs) of TT-10, TT-4 and TT-10 + TT-4 during the dose escalation phase
28 Days

All toxicities will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-10, TT-4 and TT-10 + TT-4 during the dose escalation phase
Through study completion, an average of 1 year

To confirm the maximum tolerated dose (MTD) of TT-10, TT-4 and TT-10 + TT-4, defined as the highest dose level at which \<2 out of 6 participants experience a dose-limiting toxicity

Expansion cohort primary objective - safety
Through study completion, an average of 1 year

Incidence and severity of treatment-related adverse events (TRAEs) in participants treated at the recommended phase 2 dose in the expansion phase

Secondary Endpoints
Overall Response Rate (ORR)
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Duration of Response (DoR)
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
Progression Free Survival (PFS)
From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort A: Dose EscalationEXPERIMENTALDrug: TT-10 (A2A Receptor Antagonist) * Supplied in capsules for daily oral administration twice a day (BID) * One cycle is considered 28 days * Ascending Dose levels are being explored * Dose Level 1 * Dose Level 2 * Dose Level 3 * Dose Level 4\* \*Additional dose levels may be explored, if appropriate based on emerging safety, PK or pharmacodynamic data
Cohort B: Dose EscalationEXPERIMENTALDrug: TT-4 (A2B Receptor Antagonist) * Supplied in capsules for daily oral administration once a day (QD) * One cycle is considered 28 days * Ascending Dose levels are being explored * Dose Level 1 * Dose Level 2 * Dose Level 3\* * \*Additional dose levels or frequency may be explored, if appropriate based on emerging safety, PK or pharmacodynamic data
Cohort C: Dose EscalationEXPERIMENTALDrugs: TT-10 + TT-4 - Dual Receptor Antagonists * Both drugs will be supplied in capsules for daily oral administration and administered separately. * One cycle is considered 28 days * Ascending Dose levels of both drugs are being explored and will be determined after safety review of Cohorts A and B
Interventions
NameTypeDescription
TT-10DRUGTT-10 orally administered BID
TT-4DRUGTT-4 is orally administered QD
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

To be eligible for inclusion in the dose escalation cohorts or expansion cohorts in this study, participants must meet all of the following criteria: 1. Participants must be ≥18 years of age. 2. Participants or their legal representative must be able to provide written informed consent to participa...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04969315studyFirstPostDate: changed