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Locally Advanced /Metastatic Solid TumorsPhase 1/2NCT04458389

A Phase 1/2 Study of TY101 for Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas

A Phase 1/2 study testing TY101 in people with Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas, run by Tayu Huaxia Biotech Medical Group Co., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

A multicenter, open-label, dose-escalation and dose-expansion phase 1/2 study, to evaluate TY101 safety, tolerability, pharmacokinetic characteristics, effectiveness and immunogenicity in patients with Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
TY101
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
268 participants
Where
3 sitesChina
Study dates
7 Dec 2020to 31 Jul 2025
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

  • Male or female ≥18 years
  • Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures.
  • Histological or cytological diagnosis, advanced solid tumor and lymphoma(Dose escalation phase), Or recurrence and refractory peripheral T-cell lymphoma who must have failure at least 1 prior routine regimen, or failure to tolerate the toxicity, or lack of any routine regimens, advanced squamous cell carcinoma of the skin and other advanced solid tumors and lymphoma (Dose expansion phase）
  • At least one evaluable lesion for solid tumor or lymphoma.
  • Must provide with tumor specimen that meet the requirements for biomarker testing(expression of PD-L1 and the infiltrating lymphocytes).
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the screening and without deterioration within 2 weeks before enrollment.
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  • Life expectancy ≥12 weeks
  • Adequate organ function as evidenced by meeting all the following requirements (with 14 days):
  • Hemoglobin ≥ 9.0 g/dL neutrophils ≥ 1500 cells/ µL platelets ≥ 100× 10^3/ µL;
  • Total bilirubin ≤ 1.5×upper limit of normal(ULN) aspartic transaminase (AST) and alanine transaminase (ALT) ≤ 2.5×ULN without, and ≤ 3×ULN with hepatic metastasis;
  • International Normalized Ratio (INR) ≤1.5×ULN;
  • Serum creatinine ≤1×ULN, creatinine clearance >60ml/min (Cockcroft-Gault equation).
  • The results of blood pregnancy tests must be negative for premenopausal women screened. All enrolled patients (male or female) should agree with adequate and reliable barrier contraception from signing informed consent date to the 6 months after the last dose.

Who cannot join

  • Previously received any of the following therapies:
  • 1.1 Received any other cytotoxic chemotherapeutic agents within 4 weeks prior to the first dose; for nitrosoureas and mitomycin C at least 6 weeks.
  • 1.2 Received any targeted or other anticancer drug therapy within 4 weeks prior to the first dose.
  • 1.3 Radiation therapy within 4 weeks prior to first dose (note: palliative radiotherapy for bone or palliative radiotherapy for superficial lesions was allowed, the course of treatment is based on local standards and had been ended 2 weeks before the first dose. Radiotherapy covering more than 30% of the bone marrow area within 4 weeks prior to first dose was excluded).
  • 1.4 NMPA-approved antitumor Chinese traditional medicine is in use or has been used within 2 weeks prior to the first dose.
  • Concurrent malignancy within 5 years prior to screening, except for the cured basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
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  • Patients with active central nervous system (CNS) metastasis and/or cancerous meningitis who were found on known or in the screening tests, except for the following subjects: Subjects with asymptomatic brain metastasis who need to undergo regular brain imaging examination as the site of the disease. Subjects with stable status of brain metastasis after treatment.
  • Concomitant active or suspected autoimmune disease; but patients who are in a stable state and did not require systemic immunosuppressive therapy are allowed to be enrolled.
  • A history of allogeneic organ, bone marrow transplant or stem cell transplant; A history of allogeneic organ, bone marrow or stem cell transplantation.
  • Patients with the history of or are suffering from pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe pulmonary function impairment, etc., which may interfere with the detection and management of suspected drug-related pulmonary toxicity; patients with active tuberculosis or with a history of active tuberculosis infection ≤48 weeks prior to screening, regardless of treatment.
  • Severe cardiovascular disease, such as NYHA class III or IV congestive heart failure. A history of myocardial infarction, poorly controlled arrhythmias (including QTc interphase ≥450 ms in men and ≥470 ms in women, as calculated by the Fridericia formula), or cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis, and pulmonary embolism in the 6 months prior to screening.
  • Uncontrolled hypertension (systolic blood pressure >150 mmHg and diastolic blood pressure > 100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.
  • Uncontrolled endocrine diseases (diabetes, thyroid disease, etc.).
  • Patients with active peptic ulcer or hemorrhagic disease.
  • Seriously infected persons who need to be treated with systemic antiviral or antimicrobial treatment.
  • Pericardial effusion, pleural effusion and peritoneal effusion that remained uncontrolled after intervention.
  • Patients with any other severe, acute or chronic disease that the investigator considers to be likely to interfere with participation in the study or evaluation and which the investigator determines to be inappropriate for participation in the clinical trial.
  • HIV infection.
  • Active viral hepatitis patients are excluded. Patients with serologic evidence of chronic HBV infection (defined by a positive hepatitis B surface antigen test and a positive anti-hepatitis core antigen antibody test, and the HBV-DNA); HCV infection (defined by positive HCV antibody and HCV-RNA test).
  • The history of other therapies against immune checkpoint, such as anti-PD-1, anti-PD-L1, anti-CTLA-4 or anti-LAG-3.
  • Have received steroids or other systemic immunosuppressive therapy within 14 days prior to the first dose, or have to be treated while on trial; except the following: a) The use of topical or inhaled corticosteroids, b) Glucocorticoids are used in the short term (continuous use≤7 days) to prevent or treat non-autoimmune allergic diseases.
  • History of serious allergic reaction to treatment with another monoclonal antibody.
  • A history of alcohol, drug or substance abuse.
  • Major surgery within 4 weeks prior to screening or scheduled to undergo major surgery during the trial.
  • Live virus vaccine or attenuated vaccine within 30 days prior to first dose.
  • Be in the other clinical studies now, or have participated in other intervention clinical trials in the previous 4 weeks.
  • Pregnant or breast-feeding females.
  • Any condition that the investigator believes may not be appropriate for participating the study.

Trial locations and contacts

3 sites in 1 country.

Guanwen Zeng, PhD contact

8610-85187670

kevintseng@tayubiotech.com

China3 sites, 3 recruiting

  • Cancer Hospital Chinese Academy of Medical Science

    Beijing, Beijing Municipality, 100021

    Yuankai Shi, PhD.MD, 010-87788701, syuankaipumc@126.com

    Yuankai Shi, PhD.MD

    Recruiting

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071

    Hong Wang, PhD, MD, 010-66947163, 18611707961@163.com

    Recruiting

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

    Yongsheng Wang, PhD.MD, 18980602258, wangy756@163.com

    Recruiting

Other trials in China

About this study

Official title: Phase 1 (Dose Escalation)/Phase 2 (Expansion Cohort) Trial of TY101 as a Single Agent in Patients With Locally Advanced/Metastatic Solid Tumors and Relapsed or Refractory Lymphomas

A multicenter, open-label, dose-escalation and dose-expansion phase 1/2 study, to evaluate TY101 safety, tolerability, pharmacokinetic characteristics, effectiveness and immunogenicity in patients with Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas. The study includes two parts: dose escalation and expansion cohort to evaluate the tolerability and efficacy.

Being tested
TY101
Medical subject headings
Recurrence, Lymphoma

What participants receive

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

  • TY101Drug

    Dose escalation: TY101 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg 200mg Intravenous Q3W, 2 years depending on response.

    Dose expansion: Subjects received TY101 injection for a maximum of 2 years until progressive disease, intolerant toxicity, death, or withdrawal from the study occurred.

Study groups in NCT04458389
Study groupRoleWhat they receive
TY101ExperimentalDose escalation：Humanized anti-PD-1 monoclonal antibody is to be injected intravenously 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg 200mg (fix dose) until disease progresses or unacceptable tolerability occurs. Dose expansion：After completion of the DLT observation, the sponsor and principal investigator will select a possible dose（RP2D）for dose expansion to further confirm the efficacy and safety of RP2D.
Receives: Drug: TY101

What is being measured

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

  1. Safety and Tolerability measured

    Number of Participants with treatment-related Adverse Events (AEs) by CTCAE v5.0.

    Measured: 90 days after the last dose.

  2. Dose-limiting toxicity(DLT)

    DLT is the primary endpoint for safety in the dose escalation phase and will be used to determine the maximum tolerated dose (MTD).

    Measured: 3 weeks after first dose for each dose group.

Secondary outcomes (8)

  1. Pharmacokinetics(Cmax)

    Maximum Concentration(Cmax)

    Measured: Up to approximately 12 months

  2. Pharmacokinetics(Tmax)

    Dose escalation: Peak time(Tmax)

    Measured: Up to approximately 12 months

  3. Pharmacokinetics(AUC)

    Dose escalation: Area Under Curve(AUC)

    Measured: Up to approximately 12 months

  4. Pharmacokinetics(t1/2)

    Dose escalation: half life(t1/2)

    Measured: Up to approximately 12 months

  5. Pharmacokinetics(PPK)

    Dose escalation: Population pharmacokinetics(PPK)

    Measured: The PPK evaluation will be further designed based on the results of the dose escalation phase.

  6. Objective response rate(ORR)

    Efficacy observation

    Measured: Up to approximately 12 months

  7. Overall Survival(OS)

    Efficacy observation

    Measured: Up to approximately 12 months

  8. Progression-free survival(PFS)

    Efficacy observation

    Measured: Up to approximately 12 months

Timeline

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

  1. First posted7 Jul 2020
  2. Study start7 Dec 2020
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion31 Jul 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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
TY101 injection
Masking
None (open label)
Enrolment
268 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04458389
Sponsor's protocol ID
TY101-001
Status last verified
May 2021
First submitted
1 Jul 2020
Last updated
13 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TY101 in people with Locally Advanced /Metastatic Solid Tumors and Relapsed or Refractory Lymphomas, run by Tayu Huaxia Biotech Medical Group Co., Ltd. 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 13 inclusion and 28 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 13 Aug 2021. 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 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?

Results are not available in the source record.

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

Contact Guanwen Zeng, PhD (8610-85187670, kevintseng@tayubiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability measured (time frame: 90 days after the last dose.). 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 NCT04458389.

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 13 Aug 2021.

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