TT-4 As a Single Agent in Subjects with Advanced Selected Solid Tumors

A Phase 1/2 study testing TT-4 in people with Colorectal Cancer and Gastric Cancer, run by Tarus Therapeutics, Inc..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer, Gastric Cancer, Hepatocellular Carcinoma
What is being tested?: TT-4
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 15 Dec 2022to 30 Sep 2023
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

To eligible for inclusion in the dose escalation cohort or expansion cohort 1 in this study, subjects must meet all of the following 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
Cohort A dose escalation: Colorectal Cancer, Gastric cancer, Hepatocellular Carcinoma and locally advanced, unresectable, or metastatic Pancreatic Cancer, who have failed or are not eligible for standard of care treatment.
Cohort B: Advanced colorectal cancer (CRC), who have failed or not eligible for standard of care

Show all 31Show fewer

Cohort C: Advanced Gastric cancer (GC), who have failed or not eligible for standard of care
Cohort D: Advanced Hepatocellular Carcinoma (HCC), who have failed or not eligible for standard of care
Cohort E: Locally advanced, unresectable, or metastatic Pancreatic Cancer (PANC), who have failed or not eligible for standard of care
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
Subjects must have adequate hematologic function based on the following:
Absolute neutrophil count ≥ 1.5 x 109/L
Platelet count ≥ 100 x 109/L
Hemoglobin ≥ 9.0 g/dL
Subjects must have adequate hepatic function based on the following:
Total bilirubin <1.5 × upper limit of normal (ULN) Patients with a known history of Gilbert's syndrome (≤ 3.0 × ULN) and/or isolated elevations of indirect bilirubin are eligible for study participation
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤2.5 x ULN (≤5 × ULN for subjects with known hepatic metastases)
Subjects must have adequate renal function based on the following:
Serum creatinine ≤1.5 × ULN
For women of childbearing potential (WCBP): negative serum β human chorionic gonadotropin (βhCG) pregnancy test within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 12 consecutive months for women > 55 years of age)
Human immunodeficiency virus (HIV) infected subjects must be on antiretroviral therapy (ART) and have a well-controlled HIV infection/disease defined as:
Subjects on ART must have a CD4+ T cell count >350 cells/mm3 at time of screening
Subjects on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies/mL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening
Subjects on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to study entry (Day 1).
For women of childbearing potential (WCBP): negative urine pregnancy test (UPT) within 1 week before first treatment (WCBP defined as a sexually mature woman who has not undergone surgical sterilization or who has not been naturally post-menopausal for at least 12 consecutive months for women > 55 years of age). WCBP should be placed on effective birth control directly after testing negative for pregnancy; if not, then WCBP should have a UPT on Day 1 of every cycle, prior to drug administration. Any positive or indeterminant UPT result must be confirmed by Serum.
Female subjects of childbearing potential must use a highly effective mode of contraception or abstain from heterosexual activity for the duration of the trial and for 120 days following the last dose of study medication. A female is NOT of childbearing potential if she has undergone bilateral salpingoophorectomy or is menopausal, defined as an absence of menses for 12 consecutive months. Male subjects must agree to use highly effective contraception.
Ability to adhere to the study visit schedule and all protocol requirements

Who cannot join

Subjects are to be excluded from the study if they meet any of the following 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.
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

Show all 30Show fewer

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.
Note: Subjects should remain on antiviral therapy throughout study intervention and follow local guidelines for HBV antiviral therapy post completion of study intervention.
Hepatitis B screening tests are not required unless:
Known history of HBV infection
As mandated by local health authority.
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.
Hepatitis C screening tests are not required unless:
Known history of HCV infection
As mandated by local health authority.
Subjects who require immunosuppressive therapy including, but not limited to, treatment with corticosteroids in pharmacologic doses (equivalent to ≥10 mg prednisone daily), cyclosporine, mycophenolate, azathioprine, methotrexate, adalimumab, infliximab, vedolizumab, tofacitinib, dupilumab, rituximab, etc. or systemic steroids (except for steroid use as cortisol replacement therapy in documented adrenal insufficiency)
Ongoing systemic bacterial, fungal, or viral infections at Screening
NOTE: Subjects on antimicrobial, antifungal, or antiviral prophylaxis are not specifically excluded if all other inclusion/exclusion criteria are met
Administration of a live vaccine within 30 days of first dose of study drug
Baseline QT interval corrected with Fridericia's method (QTcF) > 480 ms (average of triplicate readings)
NOTE: Criterion does not apply to subjects with a right or left bundle branch block.
Subjects with a history of Torsade de Pointes or taking QT-prolonging drugs
Prior surgery or gastrointestinal dysfunction that may affect drug absorption (eg, gastric bypass surgery, gastrectomy)
Female subjects who are pregnant or breastfeeding
Concurrent active malignancy other than non-melanoma skin cancer, carcinoma in situ of the cervix, or prostate intraepithelial neoplasia
Past medical history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis which required steroid treatment, or any evidence of clinically active interstitial lung disease
History of peptic ulcer and/or gastrointestinal bleed within the past 6 months prior to Screening
History of stroke, unstable angina, myocardial infarction, or ventricular arrhythmia requiring medication or mechanical control within the last 6 months prior to Screening
Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the subject associated with his or her participation in the study

About this study

Official title: Phase I/II First-in-Human Study of TT-4 As a Single Agent in Participants with Advanced Selected Solid Tumors

Read the detailed description

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.

Conditions: Colorectal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Pancreatic Cancer
Being tested: TT-4
Keywords: failed or not eligible for standard of care, Advanced Selected Solid Tumors, TT-4, Adenosine, Adenosine Antagonist, A2B, A2BR Inhibitor
Medical subject headings: Colorectal Neoplasms, Stomach Neoplasms, Carcinoma, Hepatocellular, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TT-4Drug
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).

Study groups in NCT04976660
Study group	Role	What they receive
Multiple Ascending Dose	Experimental	3+3 Dose escalation until MTD and/or R2PD of TT-4 is determined Receives: Drug: TT-4

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of subjects with Dose Limiting Toxicities (DLTs) of TT-4 during the dose escalation phase
All toxicities will be graded using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: 28 Days
Define the maximum tolerated dose (MTD) or phase 2 recommended dose of TT-4during the dose escalation phase
Measured: Up to 1 year
Overall Response Rate (ORR)
This is defined as complete response (CR) or PR according to RECIST 1.1 and from the first dose until documented confirmed disease progression.
Measured: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)

Secondary outcomes (6)

Incidence of treatment-emergent adverse events (TEAEs) overall and by severity, seriousness and relatedness.
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
Measured: Through study completion, an average of 1 year
Duration of Response (DoR)
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.
Measured: 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)
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.
Measured: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)]
Peak serum concentration (Cmax) of TT-4
PK Parameter
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Area under the serum concentration versus time curve (AUC) of TT-4
PK Parameter
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Half-life of TT-4
PK Parameter
Measured: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Dec 202230 Sep 2023

First posted26 Jul 2021
Study start15 Dec 2022 (estimated)
Primary completion1 Jun 2023 (estimated)
Study completion30 Sep 2023 (estimated)

Why it 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.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for Colorectal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Model description: 3+3 Design
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04976660
Sponsor's protocol ID: TT-4-101
Status last verified: Mar 2025
First submitted: 6 Jul 2021
Last updated: 18 Mar 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Antonioli L, Blandizzi C, Pacher P, Hasko G. Immunity, inflammation and cancer: a leading role for adenosine. Nat Rev Cancer. 2013 Dec;13(12):842-57. doi: 10.1038/nrc3613. Epub 2013 Nov 14.
PubMed 24226193
Cekic C, Sag D, Li Y, Theodorescu D, Strieter RM, Linden J. Adenosine A2B receptor blockade slows growth of bladder and breast tumors. J Immunol. 2012 Jan 1;188(1):198-205. doi: 10.4049/jimmunol.1101845. Epub 2011 Nov 23.
PubMed 22116822
Aherne CM, Kewley EM, Eltzschig HK. The resurgence of A2B adenosine receptor signaling. Biochim Biophys Acta. 2011 May;1808(5):1329-39. doi: 10.1016/j.bbamem.2010.05.016. Epub 2010 May 28.
PubMed 20546702
Allard B, Allard D, Buisseret L, Stagg J. The adenosine pathway in immuno-oncology. Nat Rev Clin Oncol. 2020 Oct;17(10):611-629. doi: 10.1038/s41571-020-0382-2. Epub 2020 Jun 8.
PubMed 32514148
Zhou Y, Chu X, Deng F, Tong L, Tong G, Yi Y, Liu J, Tang J, Tang Y, Xia Y, Dai Y. The adenosine A2b receptor promotes tumor progression of bladder urothelial carcinoma by enhancing MAPK signaling pathway. Oncotarget. 2017 Jul 25;8(30):48755-48768. doi: 10.18632/oncotarget.17835.
PubMed 28548944
Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.
PubMed 28271869
Horigome E, Fujieda M, Handa T, Katayama A, Ito M, Ichihara A, Tanaka D, Gombodorj N, Yoshiyama S, Yamane A, Yamada K, Horiguchi J, Shinozuka K, Oyama T, Nishiyama M, Rokudai S. Mutant TP53 modulates metastasis of triple negative breast cancer through adenosine A2b receptor signaling. Oncotarget. 2018 Oct 2;9(77):34554-34566. doi: 10.18632/oncotarget.26177. eCollection 2018 Oct 2.
PubMed 30349649
Vecchio EA, Tan CY, Gregory KJ, Christopoulos A, White PJ, May LT. Ligand-Independent Adenosine A2B Receptor Constitutive Activity as a Promoter of Prostate Cancer Cell Proliferation. J Pharmacol Exp Ther. 2016 Apr;357(1):36-44. doi: 10.1124/jpet.115.230003. Epub 2016 Jan 20.
PubMed 26791603
Lan J, Lu H, Samanta D, Salman S, Lu Y, Semenza GL. Hypoxia-inducible factor 1-dependent expression of adenosine receptor 2B promotes breast cancer stem cell enrichment. Proc Natl Acad Sci U S A. 2018 Oct 9;115(41):E9640-E9648. doi: 10.1073/pnas.1809695115. Epub 2018 Sep 21.
PubMed 30242135
Ma DF, Kondo T, Nakazawa T, Niu DF, Mochizuki K, Kawasaki T, Yamane T, Katoh R. Hypoxia-inducible adenosine A2B receptor modulates proliferation of colon carcinoma cells. Hum Pathol. 2010 Nov;41(11):1550-7. doi: 10.1016/j.humpath.2010.04.008.
PubMed 20619442
Ryzhov S, Novitskiy SV, Zaynagetdinov R, Goldstein AE, Carbone DP, Biaggioni I, Dikov MM, Feoktistov I. Host A(2B) adenosine receptors promote carcinoma growth. Neoplasia. 2008 Sep;10(9):987-95. doi: 10.1593/neo.08478.
PubMed 18714400

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer

All Colorectal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase I/II First-in-Human Study of TT-4 As a Single Agent in Participants with Advanced Selected Solid Tumors
ClinicalTrials.gov ID: NCT04976660
Acronym / sponsor ID: TT-4-101
Conditions: Colorectal Cancer, Gastric Cancer, Hepatocellular Carcinoma, Pancreatic Cancer
Keywords: failed or not eligible for standard of care, Advanced Selected Solid Tumors, TT-4, Adenosine, Adenosine Antagonist, A2B, A2BR Inhibitor
Phase: Phase 1/2
Study type: Interventional
Recruitment status: WithdrawnReason 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.
Enrolment: 0 participants (actual)
Lead sponsor: Tarus Therapeutics, Inc.Industry (pharma, biotech, devices)
Study start: 15 Dec 2022 (estimated)
Primary completion: 1 Jun 2023 (estimated)
Study completion: 30 Sep 2023 (estimated)
First posted: 26 Jul 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1
Model description: 3+3 Design

Arm	Type	Receives
Multiple Ascending Dose	Experimental	Drug: TT-43+3 Dose escalation until MTD and/or R2PD of TT-4 is determined

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (31 listed)

To eligible for inclusion in the dose escalation cohort or expansion cohort 1 in this study, subjects must meet all of the following 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

Key exclusion criteria (30 listed)

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.
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TT-4TT-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).	Drug	Multiple Ascending Dose

Primary outcome

Number of subjects with Dose Limiting Toxicities (DLTs) of TT-4 during the dose escalation phase
Time frame: 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-4during the dose escalation phase
Time frame: Up to 1 year
Overall Response Rate (ORR)
Time frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)
This is defined as complete response (CR) or PR according to RECIST 1.1 and from the first dose until documented confirmed disease progression.

6 secondary outcomes

Incidence of treatment-emergent adverse events (TEAEs) overall and by severity, seriousness and relatedness.
Time frame: Through study completion, an average of 1 year
Duration of Response (DoR)
Time frame: 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)
Time frame: From study enrollment until participant discontinuation, first occurrence of progressive disease, or death from any cause, whichever occurs first (approximately 2 years)]
Peak serum concentration (Cmax) of TT-4
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Area under the serum concentration versus time curve (AUC) of TT-4
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose
Half-life of TT-4
Time frame: Predose, 0.5, 1, 2, 4, 6, 8, 24 hours post-dose

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
Background: PubMed 24226193Antonioli L, Blandizzi C, Pacher P, Hasko G. Immunity, inflammation and cancer: a leading role for adenosine. Nat Rev Cancer. 2013 Dec;13(12):842-57. doi: 10.1038/nrc3613. Epub 2013 Nov 14.
Background: PubMed 22116822Cekic C, Sag D, Li Y, Theodorescu D, Strieter RM, Linden J. Adenosine A2B receptor blockade slows growth of bladder and breast tumors. J Immunol. 2012 Jan 1;188(1):198-205. doi: 10.4049/jimmunol.1101845. Epub 2011 Nov 23.
Background: PubMed 20546702Aherne CM, Kewley EM, Eltzschig HK. The resurgence of A2B adenosine receptor signaling. Biochim Biophys Acta. 2011 May;1808(5):1329-39. doi: 10.1016/j.bbamem.2010.05.016. Epub 2010 May 28.
Background: PubMed 32514148Allard B, Allard D, Buisseret L, Stagg J. The adenosine pathway in immuno-oncology. Nat Rev Clin Oncol. 2020 Oct;17(10):611-629. doi: 10.1038/s41571-020-0382-2. Epub 2020 Jun 8.
Background: PubMed 28548944Zhou Y, Chu X, Deng F, Tong L, Tong G, Yi Y, Liu J, Tang J, Tang Y, Xia Y, Dai Y. The adenosine A2b receptor promotes tumor progression of bladder urothelial carcinoma by enhancing MAPK signaling pathway. Oncotarget. 2017 Jul 25;8(30):48755-48768. doi: 10.18632/oncotarget.17835.
Background: PubMed 28271869Seymour L, Bogaerts J, Perrone A, Ford R, Schwartz LH, Mandrekar S, Lin NU, Litiere S, Dancey J, Chen A, Hodi FS, Therasse P, Hoekstra OS, Shankar LK, Wolchok JD, Ballinger M, Caramella C, de Vries EGE; RECIST working group. iRECIST: guidelines for response criteria for use in trials testing immunotherapeutics. Lancet Oncol. 2017 Mar;18(3):e143-e152. doi: 10.1016/S1470-2045(17)30074-8. Epub 2017 Mar 2.
Background: PubMed 30349649Horigome E, Fujieda M, Handa T, Katayama A, Ito M, Ichihara A, Tanaka D, Gombodorj N, Yoshiyama S, Yamane A, Yamada K, Horiguchi J, Shinozuka K, Oyama T, Nishiyama M, Rokudai S. Mutant TP53 modulates metastasis of triple negative breast cancer through adenosine A2b receptor signaling. Oncotarget. 2018 Oct 2;9(77):34554-34566. doi: 10.18632/oncotarget.26177. eCollection 2018 Oct 2.
Background: PubMed 26791603Vecchio EA, Tan CY, Gregory KJ, Christopoulos A, White PJ, May LT. Ligand-Independent Adenosine A2B Receptor Constitutive Activity as a Promoter of Prostate Cancer Cell Proliferation. J Pharmacol Exp Ther. 2016 Apr;357(1):36-44. doi: 10.1124/jpet.115.230003. Epub 2016 Jan 20.
Background: PubMed 30242135Lan J, Lu H, Samanta D, Salman S, Lu Y, Semenza GL. Hypoxia-inducible factor 1-dependent expression of adenosine receptor 2B promotes breast cancer stem cell enrichment. Proc Natl Acad Sci U S A. 2018 Oct 9;115(41):E9640-E9648. doi: 10.1073/pnas.1809695115. Epub 2018 Sep 21.
Background: PubMed 20619442Ma DF, Kondo T, Nakazawa T, Niu DF, Mochizuki K, Kawasaki T, Yamane T, Katoh R. Hypoxia-inducible adenosine A2B receptor modulates proliferation of colon carcinoma cells. Hum Pathol. 2010 Nov;41(11):1550-7. doi: 10.1016/j.humpath.2010.04.008.
Background: PubMed 18714400Ryzhov S, Novitskiy SV, Zaynagetdinov R, Goldstein AE, Carbone DP, Biaggioni I, Dikov MM, Feoktistov I. Host A(2B) adenosine receptors promote carcinoma growth. Neoplasia. 2008 Sep;10(9):987-95. doi: 10.1593/neo.08478.
Individual participant dataSharing planned: Undecided

Related trials for Colorectal Cancer

Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
Active, not recruitingObservational study
The IMPACT Study - Identification of Men With a Genetic Predisposition to ProstAte Cancer
Prostate Cancer, BRCA Mutation
RecruitingObservational study
ABCSG R07 Rectal Cancer Registry
Rectal Cancer, Adenocarcinoma of Rectum
Recruiting
Mainstreaming Genetics: Evaluation of a Digital Application to Scale and Spread Oncologist-initiated Genetic Testing
Cancer, Breast Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TT-4 in people with Colorectal Cancer and Gastric Cancer, run by Tarus Therapeutics, Inc..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with Dose Limiting Toxicities (DLTs) of TT-4 during the dose escalation phase (time frame: 28 Days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04976660, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.