Metastatic Castration-resistant Prostate CancerPhase 1NCT04853498
A Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
A Phase 1 study testing TQB3720 in people with Metastatic Castration-resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Metastatic Castration-resistant Prostate Cancer
- What is being tested?
- TQB3720
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteChina
- Study dates
- 9 Jun 2021to 30 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Histologically or cytologically confirmed prostate carcinoma. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.
- 3.Testosterone levels < 50 ng/dL. 4. Has received ≥1 previous regimens for metastatic castration-resistant prostate cancer.
- 5.Male subjects should agree to use an adequate method of contraception starting with signing ICF through 6 months after the last dose of study.
- 6.Understood and signed an informed consent form.
Who cannot join
- -1.Has symptomatic brain metastases or control of symptoms < 1 month. 2.Has other malignancies within 3 years. 3.Has used second-generation androgen receptor antagonists. 4. Abnormal liver function. 5. Abnormal renal function. 6. Has received any other investigational drug within 30 days weeks before first dose.
- 7. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200035
About this study
Official title: A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.
- Being tested
- TQB3720
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3720Drug
This is an androgen receptor antagonists.
| Study group | Role | What they receive |
|---|---|---|
| TQB3720 tablets | Experimental | TQB3720 tablets administered orally, once daily in 28-day cycle. Receives: Drug: TQB3720 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
Measured: Baseline up to 28 days
Secondary outcomes (3)
Cmax
Cmax is the maximum plasma concentration of TQB3720 or metabolite(s).
Measured: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
Tmax
To characterize the pharmacokinetics of TQB3720 by assessment of time to reach maximum plasma concentration.
Measured: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
AUC0-t
To characterize the pharmacokinetics of TQB3720 by assessment of area under the plasma concentration time curve from zero to infinity.
Measured: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start9 Jun 2021
- Primary completion30 Apr 2024
- Study completion30 Dec 2025
Why it stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Castration-resistant Prostate CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853498
- Sponsor's protocol ID
- TQB3720-I-01
- Status last verified
- Dec 2025
- First submitted
- 20 Apr 2021
- Last updated
- 31 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose Escalation and Expansion Study to Evaluate the Tolerance and Pharmacokinetics of TQB3720 Tablets
- ClinicalTrials.gov ID
- NCT04853498
- Acronym / sponsor ID
- TQB3720-I-01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.
- Enrolment
- 192 participants (actual)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Jun 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 21 Apr 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.
This study is conducted to investigate the pharmacokinetic and safety profiles of TQB3720 in patients with metastatic castration-resistant prostate cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3720 tablets | Experimental | Drug: TQB3720TQB3720 tablets administered orally, once daily in 28-day cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 1. Histologically or cytologically confirmed prostate carcinoma. 2.Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2; Life expectancy ≥12 weeks.
- 3.Testosterone levels < 50 ng/dL. 4. Has received ≥1 previous regimens for metastatic castration-resistant prostate cancer.
- 5.Male subjects should agree to use an adequate method of contraception starting with signing ICF through 6 months after the last dose of study.
- 6.Understood and signed an informed consent form.
Key exclusion criteria (2 listed)
- -1.Has symptomatic brain metastases or control of symptoms < 1 month. 2.Has other malignancies within 3 years. 3.Has used second-generation androgen receptor antagonists. 4. Abnormal liver function. 5. Abnormal renal function. 6. Has received any other investigational drug within 30 days weeks before first dose.
- 7. According to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
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 |
|---|---|---|
| TQB3720This is an androgen receptor antagonists. | Drug | TQB3720 tablets |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: Baseline up to 28 days
MTD was defined as the dose in which more than 2 of up to 6 patients developed a DLT.
3 secondary outcomes
Cmax
Time frame: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
Tmax
Time frame: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
AUC0-t
Time frame: 0hour, 2hour, 4hour, 8hour, 12hour, 24hour, 36hour, 48hour, 72hour, 96hour,120hour post-dose on single dose; Hour 0 of day 8、day 15、day 22；0 hour, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour post-dose on multiple dose of day 28; Hour 0 of day 42 and day 56.
Results and safety
The study was stopped early (reason given: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB3720 in people with Metastatic Castration-resistant Prostate Cancer, run by Chia Tai Tianqing Pharmaceutical Group 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 Mar 2026. 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?
The study was stopped early (reason given: Per sponsor request. Premature closure was not prompted by any safety or efficacy concerns.). Results are not available in the source record.
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?
Maximum tolerated dose (MTD) (time frame: Baseline up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Mar 2026.