Neoplasms

All Conditions

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Gland and Hormone Related Diseases

Rare Diseases

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Carcinoma, Hepatocellular

Stomach Cancer

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Anti-Arrhythmia Agents

Vasodilator Agents

Analgesics

All Drugs and Chemicals

Adenosine

3+3 Dose escalation until MTD and/or R2PD of TT-4 is determined

TT-4 orally administered QD starting at 200 mg and will be increased to 800 mg (dosing may be increased to BID, if appropriate based on emerging safety, PK or PD data).

TT-4

Sushant Kumar, PhD

Desa Rae E Pastore, MS

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.

Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-4 in subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment.

The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-4 in subjects with advanced subjects diagnosed with Colorectal Cancer (CRC), Gastric cancer (GC), Hepatocellular Carcinoma (HCC) and locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC); who have failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, antitumor activity, and efficacy of TT-4.

TT-4 as a Single Agent in Subjects With Advanced Selected Solid Tumors

Phase I/II First-in-Human Study of TT-4 as a Single Agent in Participants With Advanced Selected Solid Tumors

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

This is defined as complete response (CR) or PR according to RECIST 1.1 and from the first dose until documented confirmed disease progression.

Safety assessments will be performed on a regular basis using physical examination, spontaneous AE reporting, scheduled and unscheduled laboratory assessments, and other diagnostic evaluations as indicated. Adverse events will be reported using the Common Terminology Criteria for Adverse Events (CTCAE) v5.0

Time from first confirmed documented objective response (CR or PR) to the date of first confirmed documented objective progression of disease (PD) or death due to any cause whichever occurs first. If a subject has not had an event (PD or death), DR is censored at the date of last adequate tumor assessment.

Time from first dose to the date of the first confirmed documented objective progression of disease (PD) or death due to any cause, whichever occurs first.

Tarus Therapeutics, Inc.

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma, Non-Small-Cell Lung

Prostatic Neoplasms

Carcinoma, Squamous Cell

Carcinoma, Renal Cell

Lung Neoplasms

Squamous Cell Carcinoma of Head and Neck

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Head and Neck Neoplasms

Adenocarcinoma

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Renal Cell Carcinoma

Androgen Receptor Antagonists

3+3 Dose escalation until MTD and/or R2PD of TT-10 is determined

TT-10 orally administered BID starting at 10 mg and will be increased to 200 mg (additional dose levels maybe explored, if appropriate based on emerging safety, PK or PD data).

TT-10

The purpose of this study is to evaluate the safety and tolerability of orally administered TT-10 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-10.

Multicenter, open-label dose-escalation Phase I/II clinical study, designed to evaluate the safety, tolerability, PK, PD, anti-tumor activity, and efficacy of TT-10 in subjects diagnosed with advanced Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC) and Non-small cell lung cancer (NSCLC); who have failed or are not eligible for standard of care treatment.

The study will be conducted in two phases. Dose escalation (Phase 1) will be to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D), safety and tolerability of TT-10 in subjects with advanced subjects diagnosed with advanced Renal cell cancer (RCC), castrate resistant prostate cancer (CRPC) and Non-small cell lung cancer (NSCLC); who have failed or are not eligible for standard of care treatment. Dose expansion (Phase 2) will be to further explore the safety and tolerability of the MTD and/or RP2D, PK, PD, anti-tumor activity, and efficacy of TT-10.

TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors

Phase I/II First-in-Human Study of TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors

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

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

ORR is to be reported as the proportion of patients who have a Complete Response or Partial Response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Defined as the time from first documented objective response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 to the date of first documented radiographic progression of disease (PD) or death.

Time from first dose to the date of the first confirmed documented progression per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
TT-4 as a Single Agent in Subjects With Advanced Selected Solid Tumors	NCT04976660	Colorectal Canc... Gastric Cancer Hepatocellular ... Pancreatic Canc...	TT-4	18 Years -	Tarus Therapeutics, Inc.
TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors	NCT04969315	Renal Cell Canc... Castrate Resist... Non Small Cell ... Head and Neck S...	TT-10	18 Years -	Portage Biotech
TT-10 as a Single Agent in Subjects With Advanced Selected Solid Tumors	NCT04969315	Renal Cell Canc... Castrate Resist... Non Small Cell ... Head and Neck S...	TT-10	18 Years -	Portage Biotech

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