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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 CancerUnlock trial analytics

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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Frequently asked questions about TT-10

What is TT-10 used for?

TT-10 is an investigational small molecule being developed for the treatment of Renal Cell Cancer. It is also being studied in other advanced solid tumors, including Castrate Resistant Prostate Cancer, Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Endometrial Cancer, and Ovarian Cancer.

Who makes TT-10?

TT-10 is being developed by AlphaTON Capital Corp. (ticker: ATON). The company is currently conducting clinical trials to evaluate the safety and efficacy of TT-10 in patients with advanced solid tumors.

What phase is TT-10 in?

TT-10 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary efficacy.

What clinical trials is TT-10 in?

TT-10 is being studied in a Phase 1 clinical trial with the identifier NCT04969315. This trial evaluates TT-10 (PORT-6) and TT-4 (PORT-7) as single agents and in combination in subjects with advanced selected solid tumors. The trial is recruiting in the United States with an enrollment of 90 participants.

Is TT-10 the same as PORT-6?

Yes, TT-10 is also known as PORT-6. The clinical trial NCT04969315 refers to TT-10 as PORT-6, indicating that these names are used interchangeably for the same investigational drug.