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Breast CancerPhase 1NCT06948539

To Evaluate the Tolerability and Pharmacokinetics of TQB2101 for Injection in Patients With Advanced Malignant Tumors

A Phase 1 study testing TQB2101 for injection in people with Breast Cancer and Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

To explore the tolerability and pharmacokinetics of TQB2101 for injection in subjects with advanced malignant tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Lung Cancer, Colorectal Cancer
What is being tested?
TQB2101 for injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteChina
Study dates
Apr 2025to Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

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

  • The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
  • 18 years old ≤ age ≤75 years old (calculated on the date of signing the informed consent);
  • Eastern Cooperative Oncology Group (ECOG) score 0~1;
  • Expected survival greater than 12 weeks;
  • Patients with advanced solid tumors confirmed by cytology/histopathology, failure of standard treatment or lack of effective treatment ; Participants with Receptor Tyrosine Kinase-Like Orphan Receptor 1 (ROR1) -positive advanced solid tumors were enrolled in the extended study phase.
  • Evidence of at least one measurable lesion according to RECIST 1.1 criteria, except that the dose-escalation phase is not required to be measurable, as long as it meets the assessment of disease status.
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  • The main organs function well and meet the following criteria:
  • Hemoglobin (HGB) ≥80g/L;
  • Absolute neutrophil count (ANC) of solid tumor subjects ≥1.5×109 /L;
  • Platelet count (PLT) ≥100×109/L, if accompanied by bone marrow invasion, platelet ≥75×109/L;
  • Total bilirubin (TBIL) ≤1.5 times the upper limit of normal value (ULN);
  • Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5×ULN. ALT and AST≤5×ULN if accompanied by liver metastasis;
  • Serum creatinine (CR) ≤1.5×ULN or creatinine clearance (CCR) ≥60 mL /min (standard Cockcroft-Gault formula was applied;
  • Prothrombin time (PT), activated partial thromboplastin time (APTT), International standardized ratio (INR) ≤ 1.5×ULN (no anticoagulant therapy);
  • Women of reproductive age should agree that effective contraception must be used during the study period and for 6 months after the end of the study, and that serum or urine pregnancy tests are negative within 7 days prior to study enrollment; Men should agree that effective birth control must be used during the study period and for 6 months after the end of the study period.

Who cannot join

  • Had or was currently suffering from other malignant tumors within 3 years prior to the first medication.
  • There are multiple factors that affect intravenous injection, venous blood collection diseases, or have an impact on oral drugs.
  • The adverse reactions of previous treatment failed to recover to Common Terminology Criteria for Adverse Events Version 5 (CTCAEv5.0) score ≤1.
  • Patients who had major surgical treatment, significant traumatic injury, or potential major surgery during the expected study treatment period within 4 weeks prior to initial medication, or who had long-term unhealed wounds or fractures.
  • Subjects who have had any bleeding event ≥CTCAEv5.0 level 3 within 4 weeks prior to initial dosing, or who have bleeding or clotting disease and are taking warfarin, aspirin, or other antiplatelet agglutinating agents (except maintenance doses) : Subjects with aspirin ≤100mg/ day, clopidogrel ≤75mg/ day, or with any signs of bleeding or medical history determined by the investigator to be unsuitable for enrollment.
  • Patients who experienced a hyperarterial/venous thrombosis event, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism, within 6 months before the first administration of the drug.
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  • Chronic hepatitis B active or active hepatitis C subjects. Subjects who are positive for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV) antibodies during screening should undergo Hepatitis B Virus (HBV) DNA titer testing or HCV RNA testing.
  • Patients with active syphilis who need treatment.
  • There is a history of active pulmonary tuberculosis, idiopathic pulmonary fibrosis, institutional pneumonia, drug-induced pneumonia, radiation pneumonia requiring treatment, or active pneumonia with clinical symptoms.
  • Those who have a history of psychotropic drug abuse and cannot quit or have mental disorders.
  • Decompensated stage of cirrhosis and history of hepatic encephalopathy.
  • Subjects with clinically significant cardiovascular disease, including any of the following:
  • Participants who had acute myocardial infarction and severe/unstable angina pectoris within 6 months before the start of study treatment; Or have heart failure of the New York Heart Association's heart function classification level 2 or higher;
  • QT interval prolongation at rest as corrected by Fridericia Formula (QTcF), QTc interval ≥450ms(male), QTc interval ≥470 ms(female);
  • Have a past or ongoing history of severe uncontrolled ventricular arrhythmias requiring medical treatment;
  • Left ventricular ejection fraction (LVEF) < 50%;
  • Congenital long QT syndrome, or any known history of tip torsion ventricular Torsades de Pointes (TdP);
  • Clinically uncontrolled hypertension (systolic blood pressure ≥150 mmHg and/or diastolic blood pressure ≥90 mmHg after standard antihypertensive therapy) and a history of hypertensive encephalopathy/hypertensive crisis.
  • Active or uncontrolled severe infection (≥CTC AEv5.0 grade 2 infection).
  • Patients with renal failure requiring hemodialysis or peritoneal dialysis.
  • Have a history of immunodeficiency, including HIV positivity or other acquired or congenital immunodeficiency diseases.
  • Subjects with (non-infectious) pneumonia/interstitial lung disease requiring steroid treatment or who currently have non-infectious pneumonia/interstitial lung disease or have been hospitalized for any active infection or received therapeutic antibiotics in the 4 weeks prior to beginning study treatment, including but not limited to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.
  • People who have epilepsy and need treatment.
  • Urine routine indicated urine protein ≥ ++, and confirmed 24-hour urine protein quantity > 1.0 g.
  • Poor diabetes control (fasting blood glucose (FBG) > 10mmol/L).
  • Tumor-related symptoms and treatment:
  • For subjects who have received chemotherapy, immunotherapy within 4 weeks prior to the first dose, radiation therapy or small molecule targeted drugs within 2 weeks, or who are still within the 5 half-lives of the drug (depending on the shortest time of occurrence), the washout period is calculated from the end time of the last treatment;
  • Within 2 weeks before the first drug use, it has been treated with Chinese patent medicines (including compound Cantharides capsule, Kangai injection, Kanglaite capsule/injection, Aidi injection, Bruceae oil injection/capsule, Xiaoaiping tablet/injection, hualbufatin capsule, etc.) with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions;
  • Imaging (CT or MRI) shows that the tumor has invaded important blood vessels, or the investigator determines that the tumor is highly likely to invade important blood vessels during the follow-up study period and cause fatal massive bleeding;
  • Uncontrolled pleuroceliac or pericardial effusion requiring repeated drainage or obvious symptoms. Subjects who are asymptomatic and have not received drainage or other treatment in the first 2 weeks of enrollment can be enrolled if imaging shows only small amounts of pleural effusion, ascites, or pericardial effusion.
  • Known allergy to study drug excipients.
  • Previous therapy with targeted ROR1 inhibitors.
  • Participants who have participated in a clinical trial of another antitumor drug (calculated as the last use of the investigational drug) within 4 weeks prior to initial administration and have used the investigational drug, or are still within 5 half-lives of the investigational drug (whichever is shorter).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Rui Hua Xu, Doctor contact

+86 17600401750

xurh@sysucc.org.cn

Feng Wang, Doctor contact

+86 18191965905

wangfeng@sysucc.org.cn

China1 site

  • Sun Yat-sen University Cancer Prevention Center

    Guanzhou, Guangdong, 510080

    Rui Hua Xu, Doctor, +86 17600401750, xurh@sysucc.org.cn

Other trials in China

About this study

Official title: A Phase I Clinical Trial Evaluating the Tolerability and Pharmacokinetics of TQB2101 for Injection in Subjects With Advanced Malignancies

To explore the tolerability and pharmacokinetics of TQB2101 for injection in subjects with advanced malignant tumors.

Being tested
TQB2101 for injection
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Colorectal Neoplasms

What participants receive

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

  • TQB2101 for injectionDrug

    TQB2101 for injection is a receptor tyrosine kinase-like orphan receptor-1 antibody drug conjugate.

Study groups in NCT06948539
Study groupRoleWhat they receive
TQB2101 injectionExperimentalThe drug was administered every 3 weeks for 21 consecutive days in a treatment cycle.
Receives: Drug: TQB2101 for injection

What is being measured

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

  1. Phase II recommended doses (RP2D)

    The dosage of drug therapy recommended for use in the second phase of clinical trials (i.e., phase II clinical trials).

    Measured: Baseline up to 24 months

  2. Dose-limiting toxicity (DLT)

    Adverse events that meet the protocol definition of dose-limiting toxic event timing were evaluated according to the Common Terminology Criteria for Adverse Events 5.0.

    Measured: Up to 1 month

  3. Maximum tolerated dose (MTD)

    The previous dose of the dose group in which dose-limiting toxicity occurs is the maximum tolerated dose.

    Measured: Up to 1 month

Secondary outcomes (5)

  1. Incidence and severity of adverse event (AE) and serious adverse event (SAE), and abnormal laboratory test indicators

    Incidence and severity of AE and SAE, and abnormal laboratory test indicators

    Measured: Up to 24 months

  2. Peak time

    Time to peak blood concentration after a single dose.

    Measured: Up to 4 months

  3. Peak concentration Cmax

    After a single dose, the highest point of the drug-time curve is called the peak concentration.

    Measured: Up to 4 months

  4. Plasma elimination half-life t1/2

    The amount of time it takes for the concentration of the drug in the blood, or the amount of drug in the body, to drop to about half of its original level.

    Measured: Up to 4 months

  5. Objective response rate

    The objective response rate of injection form TQB2101 in patients with advanced solid tumors.

    Measured: Up to 24 months

Timeline

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

  1. First posted29 Apr 2025
  2. Study startApr 2025 (estimated)
  3. Primary completionOct 2026 (estimated)
  4. Study completionDec 2026 (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
66 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06948539
Sponsor's protocol ID
TQB2101-I-01
Status last verified
Dec 2024
First submitted
17 Apr 2025
Last updated
29 Apr 2025
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 TQB2101 for injection in people with Breast Cancer and Lung Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 1 site 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 15 inclusion and 33 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: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Rui Hua Xu, Doctor (+86 17600401750, xurh@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase II recommended doses (RP2D) (time frame: Baseline up to 24 months). 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 NCT06948539.

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 29 Apr 2025.

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