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Metastatic Castration-resistant Prostate CancerPhase 1/2NCT07172126

Clinical Trial to Evaluate the Tolerance of TQB3201 Tablets

A Phase 1/2 study testing TQB3201 tablets in people with Metastatic Castration-resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 3 sites 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

TQB3201 is an orally administered targeted protein chimera (PROTAC) drug in which one end of the drug is attached to a ligand that binds to Androgen Receptor (AR) and the other end to a ligand of E3 ligase (CRBN) via a linker. Read more about this study

Who is it for?
Ages 18 years and older, men only
What is being tested?
TQB3201 tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
291 participants
Where
3 sitesChina
Study dates
Sep 2025to Dec 2028
Phase
Phase 1/2
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
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically or cytologically confirmed adenocarcinoma of the prostate;
  • Age≥ 18 years old (calculated from the date of signing the informed consent form);
  • Eastern Cooperative Oncology Group Performance Status(ECOG )score 0-1 points;
  • Presence of metastatic disease confirmed by imaging;
  • Serum testosterone level ≤ 1.73 nmol/L (50 ng/dL) at screening;
  • Sufficient samples should be provided for gene mutation detection to determine androgen receptor gene status.
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  • Patients who have progressed on the basis of at least 1 new endocrine drug;
  • The laboratory inspection meets the following standards:
  • Hemoglobin (HGB) ≥90g/L;
  • Absolute neutrophil value (NEUT) ≥1.5×109/L;
  • Platelet count (PLT) ≥75×109/L.
  • Total bilirubin (TBIL) ≤2 times the upper limit of normal (ULN); (3×ULN for patients with Gilbert syndrome ≤);
  • Alanine transferase (ALT) and aspartate transferase (AST) ≤2.5× ULN. If accompanied by liver metastasis, ALT and AST ≤ 5× ULN;
  • Serum creatinine (CR) ≤1.5× ULN or creatinine clearance estimated by the Cockcroft-Gault glomerular filtration formula ≥ 60 mL/min.
  • Urine routine: urine protein <; If the urine protein is ≥, the 24-hour urine protein quantitative ≤ 1.0 g should be confirmed.
  • Prothrombin time (PT), activated partial thromboplastin time (APTT), international normalized ratio (INR) ≤1.5× ULN (no anticoagulant therapy);
  • Cardiac color ultrasound assessment: left ventricular ejection fraction (LVEF) ≥50%; > 12-lead ECG assessment: QT interval corrected by Fridericia's formula (QTcF) <450ms (males).
  • Men of childbearing potential and their partners of the opposite sex must agree to take effective contraceptive measures from the signing of the informed consent form until 6 months after the last dose of study drug;
  • Subjects voluntarily joined this study, signed the informed consent form, and had good compliance.

Who cannot join

  • Subjects with brain metastases with symptoms or symptom control time of less than 1 month;
  • Within 5 years before the first dose of medication or other malignant tumors at the same time.
  • Imaging ( Computed Tomography or Magnetic Resonance Imaging) shows that the tumor/metastasis has invaded important blood vessels, or the tumor/metastasis is very likely to invade important blood vessels during the follow-up study period, causing major bleeding;
  • Severe bone damage caused by bone metastasis; Pathological fractures and spinal cord compression of important parts that occurred within the past 6 months or are expected to occur in the near future as judged by the investigator;
  • Pleural effusion, pericardial effusion or ascites that cannot be controlled and still needs to be repeatedly drained (judged by the investigator);
  • Diseases affecting intravenous injection and intravenous blood collection, or having multiple factors affecting oral drugs (such as inability to swallow, chronic diarrhea and intestinal obstruction, etc.);
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  • Adverse reactions of previous treatment have not recovered to Common Terminology Criteria (CTC) adverse event (AE) v5.0 grade ≤1, except for grade 2 alopecia, grade 2 peripheral neurotoxicity, grade 2 anemia, non-clinically significant and asymptomatic laboratory abnormalities, hypothyroidism stable on hormone replacement therapy, and other toxicities judged by the investigator to have no safety risk;
  • Have previously used or plan to use other similar drugs during the study;
  • Those who have received surgery, radiotherapy, radiotherapy, or local therapy (such as radiofrequency ablation, freezing, high-energy focused ultrasound, etc.) for prostate cancer after being diagnosed with metastatic prostate cancer;
  • Previous use of 5-ɑ reductase inhibitors within 4 weeks before the first dose; Systemic treatment with estrogens, progesterones, steroids (except for temporary use for anti-allergic use); First-generation AR antagonists; targeted therapy; biological therapy; immunotherapy; nuclide therapy; Botanicals known to have antitumor or PSA-lowering effects; Study treatments in other clinical trials.
  • Those who have undergone major surgical treatment, obvious traumatic injuries, or are allowed to undergo major surgery during the expected study treatment period within 4 weeks before the first dose, or have long-term unhealed wounds or fractures. (Major surgery is defined as: surgery of grade 3 or above in the 2022 edition of the National Surgical Grading Catalogue).
  • Subjects with any bleeding or bleeding event ≥Common Terminology Criteria for Adverse Events（CTCAE ）grade 3 within 4 weeks before the first dose.
  • Active viral hepatitis with poor control.
  • Active syphilis infection requiring treatment; Presence of active tuberculosis, history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, radiation pneumonitis requiring treatment, or active pneumonitis with clinical symptoms; Active or uncontrolled serious infection (≥CTC AE grade 2 infection);
  • Those who have a history of psychotropic substance abuse and cannot abstain from it, or have mental disorders or have a history of drug use.
  • Those who are ready to undergo or have previously received allogeneic bone marrow transplantation or solid organ transplantation, or have received hematopoietic stem cell transplantation within 60 days before the first dose, or have obvious host transplant responses;
  • Decompensated cirrhosis (Child-Pugh liver function grade B or C) or history of hepatic encephalopathy.
  • Suffering from major cardiovascular and cerebrovascular diseases；
  • Renal failure requiring hemodialysis or peritoneal dialysis;
  • History of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases;
  • Subjects who require immunosuppressive agents, or systemic, or absorbable topical hormone therapy for immunosuppressive purposes and continue to use it within 7 days prior to the first dose (daily dose of glucocorticoids <except 10 mg prednisone or other equivalent efficacy hormones);
  • Known allergy to the excipient components of the study drug;
  • History of pituitary or adrenal dysfunction;
  • Diseases that are serious or not well controlled and judged by the investigator to be at greater risk of entering this study, such as type 1 or type 2 diabetes, hyperlipidemia, thyroid disease, etc. that cannot be controlled by drugs.
  • Estimated insufficient compliance to participate in this clinical study.

Trial locations and contacts

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

Dingwei Ye, Doctor contact

13701663571

dwyeli@163.com

China3 sites

  • Cancer Hospital Affiliated to Chongqing University

    Chongqing, Chongqing Municipality, 400000

    Junyong Dai, Doctor, 18623251528, 11779621@qq.com

    Yi Gong, Doctor, 13228685295, gongyi_95@163.com

  • Cancer Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 201321

    Dingwei Ye, Doctor, 13701663571, dwyeli@163.com

  • The Fifth Affiliated Hospital of Sun Yat-sen University

    Zhuhai, Guangdong, 519000

    Tianyun Lin, Doctor, 13724008338, ltxgcp2017@163.com

Other trials in China

About this study

Official title: A Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of TQB3201 Tablets in Patients With Advanced Prostate Cancer

TQB3201 is an orally administered targeted protein chimera (PROTAC) drug in which one end of the drug is attached to a ligand that binds to Androgen Receptor (AR) and the other end to a ligand of E3 ligase (CRBN) via a linker. The phase I phase of this trial aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3201 tablets for the treatment of advanced prostate cancer.

Being tested
TQB3201 tablets

What participants receive

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

  • TQB3201 tabletsDrug

    TQB3201 is an orally administered targeted protein chimera (PROTAC) drug in which one end of the drug is attached to a ligand that binds to AR and the other end to a ligand of E3 ligase (CRBN) via a linker. This product is effective against anti-androgen drugs (such as abiraterone, enzalutamide, etc.) resistance mutations, including AR amplification, point mutations (L702H, H875Y, T878A mutations, etc.), and can target the degradation of wild-type AR and AR ligand-binding domain mutants, especially L702H mutations, which is a new generation of AR-PROTAC.

Study groups in NCT07172126
Study groupRoleWhat they receive
TQB3201 tabletsExperimentalEach enrolled subject received 28 consecutive days of administration, once daily after meals. (25mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg)
Receives: Drug: TQB3201 tablets

What is being measured

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

  1. Dose Limiting Toxicity (DLT)

    DLTs are defined as toxicities that occur from the first dose to the end of the first treatment cycle by the severity criteria related to the trial drug (according to Common Terminology Criteria for Adverse Events v5.0 toxicity evaluation criteria) .

    Measured: Up to 28days

  2. Maximum tolerated dose (MTD)

    The MTD was defined as the highest dose in ≥ 6 evaluable subjects without any of the following:

    1. In the DLT evaluation window, DLT occurred in 2 out of 3 subjects;
    2. In the DLT evaluation window, 1 of the first 3 subjects had DLT, and 3 more subjects were added and 1 case had ≥ DLT.

    Measured: Up to 28days

  3. Phase II Recommended Dose (RP2D)

    The RP2D will be determined based on the safety and tolerability information of the Phase I dose escalation phase and the efficacy and safety information of the Phase II phase.

    Measured: Up to 2 years

  4. Radiographic progression-free survival (rPFS)

    The time from randomization to the first occurrence of either radiologically confirmed disease progression or death from any cause, whichever comes first.

    Measured: Up to 2 years

Secondary outcomes (11)

  1. Adverse events (AEs)

    Incidence and severity of adverse events, as determined by the NCI Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grading scale.

    Incidence and severity of adverse events (AEs) and serious adverse events (SAEs) and abnormal laboratory values.

    Measured: Up to 2 years

  2. The area under the curve (AUC)

    The area under the curve (AUC) of serum concentration of TQB3201.

    Measured: cycle1 day1pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose, cycle1 day7, 14 pre-dose, cycle1 day 28 pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose

  3. Peak concentration (Cmax)

    Maximum observed concentration (Cmax) of TQB3201 antibody

    Measured: cycle1 day1pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose, cycle1 day7, 14 pre-dose, cycle1 day 28 pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose

  4. Terminal half-life (T1/2)

    Terminal half-life (T1/2)

    Measured: cycle1 day1pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose, cycle1 day7, 14 pre-dose, cycle1 day 28 pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose

  5. Apparent Clearance (CL/F)

    Apparent clearance refers to the rate of drug removal in the body, which reflects the degree of drug elimination in the body, as well as the bioavailability of the drug in the body.

    Measured: cycle1 day1pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose, cycle1 day7, 14 pre-dose, cycle1 day 28 pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose

  6. Volume of Distribution at Steady State (Vss/F)

    When the drug distribution in plasma and tissue reaches equilibrium, the drug distribution in the body body according to the plasma drug concentration at this time is the required body fluid volume called apparent distribution volume.

    Measured: cycle1 day1pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose, cycle1 day7, 14 pre-dose, cycle1 day 28 pre-dose, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours after dose

  7. Objective Response Rate (ORR)

    Patients with soft tissue (nodes, visceral) lesions that can be evaluated according to RECIST 1.1 criteria, the proportion of cases with the best total response of soft tissue lesions as confirmed complete response (CR) and confirmed partial response (PR).

    Measured: Up to 2 years

  8. Prostate-Specific Antigen Response Rate

    Percentage of subjects whose Prostate-Specific Antigen (PSA) decreased by more than 50% from baseline and maintained for more than 4 weeks.

    Measured: Up to 2 years

  9. To PSA progression time

    Refers to the time from the start of randomization to the confirmation of PSA progression.

    Measured: Up to 2 years

  10. Time to symptomatic bone-related events (SSEs)

    Refers to the time from the randomization date to the first occurrence of symptomatic bone-related events, including the use of external beam radiation therapy (EBRT) to prevent or relieve bone symptoms, the development of new symptomatic pathological fractures (vertebral or non-vertebrae), spinal cord compression, and tumor-related orthopedic surgical intervention, whichever occurs first. Symptomatic bone-related events do not include asymptomatic fractures identified by imaging.

    Measured: Up to 2 years

  11. Overall Survival (OS)

    Refers to the time from randomization to death from any cause.

    Measured: Up to 2 years

Timeline

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

  1. First posted15 Sep 2025
  2. Study startSep 2025 (estimated)
  3. Primary completionApr 2027 (estimated)
  4. Study completionDec 2028 (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
Masking
None (open label)
Enrolment
291 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07172126
Sponsor's protocol ID
TQB3201-I/II-01
Status last verified
Apr 2025
First submitted
8 Sep 2025
Last updated
15 Sep 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing TQB3201 tablets in people with Metastatic Castration-resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical 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 19 inclusion and 25 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 15 Sep 2025. 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?

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 Dingwei Ye, Doctor (13701663571, dwyeli@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose Limiting Toxicity (DLT) (time frame: Up to 28days). The study lists 4 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 NCT07172126.

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 15 Sep 2025.

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