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Advanced Solid TumorPhase 1NCT05673538

TT-00973-MS Tablets in Patients With Advanced Solid Tumors

A Phase 1 study testing TT-00973-MS tablets treatment in people with Advanced Solid Tumor, run by TransThera Sciences (Nanjing), Inc. at 3 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is a multicenter, open-label, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TT-00973-MS tablets in patients with solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
TT-00973-MS tablets treatment
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
3 sitesChina
Study dates
Jan 2023to Dec 2025
Phase
Phase 1
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

  • Subject is ≥ 18 years of age
  • Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients have failed standard treatment, have no standard treatment, or are not suitable for standard treatment at this stage as determined by the investigator.
  • Must have at least one evaluable lesion in dose escalation period and one unidimensional measurable lesion according to RECIST version 1.1;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
  • Life expectancy ≥3 months;
  • Patients must have adequate organ functions as indicated by the following screening laboratory values: ANC ≥ 1.5×10^9/L; PLT ≥ 75×10^9/L; Hb ≥ 90 g/L; TBIL ≤ 1.5×ULN；ALT和AST ≤ 3×ULN(ALT and AST≤5×ULN for subjects with liver cancer or hepatic metastases); Cr ≤ 1.5×ULN or CLcr >50mL/min(according to Cockcroft-Gault); APTT≤ 1.5×ULN; INR≤ 1.5×ULN.
  • Men and women of childbearing potential are willing to employ an effective method of contraception for the entire duration of study and 6 months after the last dose, and female subjects of childbearing potential have a negative pregnancy test at baseline.
  • Written, signed, and dated informed consent to participate in this study.

Who cannot join

  • Previous treatment with any AXL inhibitors.
  • Anticancer treatment including radiation therapy, chemotherapy, hormonal therapy, molecular targeted therapy, or immunotherapy within 4 weeks prior to the first dose of TT-00973-MS.
  • Have systematic hormonal therapy(prednisone>10mg/d or similar drugs with equivalent dose)or immunosuppressor therapy with 14 days prior to the first dose of study drug, except using topical,ocular,intra-articular,intranasal,inhaled corticosteroids,and preventive therapy using corticosteroids in short period(for instance,to prevent hypersensitivity to contrast media).
  • Participate in other clinical trials within 4 weeks prior to first dose administration.
  • Concomitant use of any strong inhibitors or inducers of CYP3A4, and can not withdrawal at least 1 week before the first dose of study drug.
  • History of allogeneic hematopoietic stem cell transplantation or organ transplantation.
Show all 21Show fewer
  • Adverse events occurred during previous anticancer therapy have not been recovered to ≤1(CTCAE 5.0)except toxicity with no significant risk determined by investigators such as alopecia.
  • Evidence of central nervous system (CNS) metastases accompanied with clinical symptoms, or other evidence of uncontrolled CNS metastases judged by investigators that the patient should not participate in the study.
  • Presence of grade 3 or 4 gastrointestinal bleeding or esophageal and gastric varices in three months prior to enrollment.
  • Have moderate or severe cardiac disease, including but not limited to severe arrhythmias or abnormal cardiac conduction, such as ventricular arrhythmias requiring clinical intervention, degree II-III atrioventricular block,QTcF≥450 ms for male, QTcF≥470 ms for female, or other structural heart disease with high risk as determined by investigators;history of acute coronary syndrome, congestive heart failure,aortic dissection,stroke or other≥grade 3 cardiovascular and cerebrovascular events within 6 months prior to the first dose of study drug;New York Heart Association (NYHA) Class II or greater heart failure, or LVEF<50% ;uncontrolled hypertension;any risk factors to increase QTc or arrhythmias, including heart failure,hypokalemia,congenital long QTc syndrome,family history of long QT interval syndrome or history of unexplained sudden death occurred in first degree relative less than 40 years of age, or using any concomitant medication known to produce QTc prolongation.
  • Have active infection requiring systemic with one week prior to the first dose the study drug.
  • Infection with hepatitis B virus(HBV DNA≥10^3 copies/mL )and hepatitis C virus(HCV RNA above the lower limit of detection) .
  • History of immune deficiency including HIV antibody positive.
  • Have received any live or attenuated live vaccine within 4 weeks prior to the first dose.
  • Major surgery(not include biopsy),or significant traumatism,or requiring selective operation within 4 weeks prior to study entry.
  • Inability to swallow the drug, or severe gastrointestinal disease affecting absorption of the drug.
  • Uncontrolled effusion in the third space, not suitable for entry as determined by the investigator.
  • With alcohol or drug abuse disorder.
  • With mental disorders or non-compliance.
  • Women who are pregnancy or breastfeeding.
  • Judgment by the investigator that the patient should not participate in the study.

Trial locations and contacts

3 sites in 1 country.

Caixia Sun, PhD contact

025-58216298

clinicaltrial@transtherabio.com

China3 sites

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

    Huan Zhou, MD, zhouhuanbest@163.com

  • Hunan Cancer Hospital

    Changsha, Hunan

    Jing Wang, MD

  • Anhui Provincial Hospital

    Hefei, Anhui

    Weidong Zhao, MD, vctorzhao@ustc.edu.cn

Other trials in China

About this study

Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TT-00973-MS Tablets in Patients With Advanced Solid Tumors

This study is a multicenter, open-label, phase 1 study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of TT-00973-MS tablets in patients with solid tumors.

Read the detailed description

A modified 3+3 design will be used to determine the maximum tolerated dose(MTD) during dose escalation period. Futher expansion period will enroll additional 12~18 patients at the appropriate dose to futher evaluate the safety and preliminary efficacy of TT-00973-MS.

Being tested
TT-00973-MS tablets treatment

What participants receive

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

  • TT-00973-MS tablets treatmentDrug

    The dose levels to be tested in the dose escalation cohorts are 2, 5, 10, 17, 25, 32, 40 and 50mg QD. All the subjects will receive TT-00973-MS tablets QD until disease progression or occurrence of intolerant adverse reactions.

Study groups in NCT05673538
Study groupRoleWhat they receive
TT-00973-MS TabletsExperimentalTT-00973-MS tablets will be administered at the starting dose of 2mg. Subsequently, patients will be enrolled according to the standard 3+3 dose escalation design.
Receives: Drug: TT-00973-MS tablets treatment

What is being measured

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

  1. Incidence of Dose Limiting Toxicity (DLT)

    To evaluate the incidence of DLT and determine the maximum tolerated dose.

    Measured: At the end Cycle 1(each cycle is 28 days)

  2. Incidence of adverse events and sevious adverse events

    To evaluate the safety and tolerability of TT-00973-MS tablets administered orally in patients with advanced solid tumors. NCI CTCAE 5.0 grading system will be used to determine the severity.

    Measured: Adverse events are collected from the patient's first dose of TT-00973-MS until 28 days following the last dose of study drug.

Secondary outcomes (9)

  1. Peak plasma concentration (Cmax)

    Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1

  2. Area under the plasma concentration versus time curve (AUC)

    Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose; pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1

  3. Time to reach maximum plasma concentration (Tmax)

    Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose;pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1

  4. terminal half-life (T1/2)

    Measured: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours post-dose on Day 1 single dose;pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 24 hours post-dose on Day 28 of Cycle 1

  5. Objective response rate(ORR)

    ORR is defined as the rate of CR and PR.

    Measured: Up to approximately 1 year

  6. Objective response rate(DCR)

    DCR is defined as the rate of CR, PR and SD.

    Measured: Up to approximately 1 year

  7. Progression-free survival(PFS)

    PFS will be calculated from the date of first dose to the date of documented confirmed relapse/progression or death, whichever occurs first.

    Measured: Until the date of documented confirmed relapse/progression or death, whichever occurs first, assessed up to 1 year.

  8. Duration of response(DOR)

    DOR will be calculated as the date of the first documented CR/PR to the date of the first documented confirmed relapse or death, whichever occurs first.

    Measured: Up to approximately 1 year

  9. Overall survival(OS)

    Overall survival is defined as the time from first dose to the date of death due to any cause.

    Measured: Up to approximately 1 year

Timeline

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

  1. First posted6 Jan 2023
  2. Study startJan 2023 (estimated)
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05673538
Sponsor's protocol ID
TT00973CN02
Status last verified
Nov 2022
First submitted
3 Nov 2022
Last updated
10 Jan 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing TT-00973-MS tablets treatment in people with Advanced Solid Tumor, run by TransThera Sciences (Nanjing), Inc. at 3 sites in China.

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 8 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Contact Caixia Sun, PhD (025-58216298, clinicaltrial@transtherabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Dose Limiting Toxicity (DLT) (time frame: At the end Cycle 1(each cycle is 28 days)). The study lists 2 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 NCT05673538.

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 10 Jan 2023; AzTrials last refreshed its copy on 3 Nov 2026.

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