TT-4 As a Single Agent in Subjects with Advanced Selected Solid Tumors (NCT04976660) | Clinical Trial Compass
WithdrawnPhase 1/2
TT-4 As a Single Agent in Subjects with Advanced Selected Solid Tumors
Stopped: Tarus is conducting clinical development under a single IND, specifically IND for TT-10 (PORT-6). Tarus has withdrawn Study TT-4-101 under the TT-4 IND; however the TT-4 IND will remain active.
0Started 2022-12-15
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of orally administered TT-4 in subjects with advanced selected solid tumors. The dose escalation portion of the study will determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of TT-4.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subjects must be ≥18 years of age.
✓. Subjects or their legal representative must be able to provide written informed consent to participate in the trial prior to the performance of any study-specific procedures.
✓. Diagnosis of histologically or cytologically confirmed advanced selected solid tumors
✓. ECOG performance status (PS) score 0-1
✓. Have measurable disease per RECIST 1.1 or (for subjects in the expansion cohorts) iRECIST as assessed by the local site investigator/radiology. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
✓. Subjects must have locally advanced, recurrent or metastatic neoplastic disease that is not curable by currently available therapies.
✓. Failure to respond to standard therapy, or for whom no appropriate therapies are available (based on the judgment of the Investigator)
✓. Life expectancy of ≥ 3 months
Exclusion criteria
✕. Major surgery within 4 weeks prior to Screening
✕. Anti-cancer therapy, such as chemotherapy, immunotherapy, hormonal therapy, targeted therapy, or investigational agents within five half-lives or four weeks, whichever is shorter, prior to administration of the first dose of study treatment.
✕. Subjects with active central nervous system (CNS) metastases; however, subjects who have undergone radiation and/or surgery for the treatment of CNS metastases, who are neurologically stable, and who are no longer taking pharmacologic doses of corticosteroids are eligible; subjects with leptomeningeal metastases are not eligible.
What they're measuring
1
Number of subjects with Dose Limiting Toxicities (DLTs) of TT-4 during the dose escalation phase
Timeframe: 28 Days
2
Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-4during the dose escalation phase
Timeframe: Up to 1 year
3
Overall Response Rate (ORR)
Timeframe: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
✕. Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.
✕. Primary CNS malignancy
✕. HIV-infected subjects with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
✕. Subjects who are hepatitis B surface antigen positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to enrollment.
✕. Subjects with a history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening. Note: Subjects must have completed curative antiviral therapy at least 4 weeks prior to enrollment.