Advanced CancerPhase 1NCT07291050
A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3217 Tablets in Subjects With Advanced Malignant Tumors
A Phase 1 study testing TQB3217Tablets in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 1 site in China.
Trial summary
This is the first-in-human clinical study of TQB3217, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3217 in advanced solid tumors, and to preliminarily explore its efficacy in solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Cancer
- What is being tested?
- TQB3217Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
- Gender is not restricted; Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; expected survival period ≥ 3 months;
- Patients with histologically or cytologically confirmed advanced malignant solid tumors that have failed standard treatment (disease progression or intolerance) or for which there is no standard treatment plan;
- The main organs function well;
- Women of childbearing age should take effective contraceptive measures during the study and within 6 months after the end of the study; serum or urine pregnancy test must be negative within 7 days before enrollment, and they must be non-lactating subjects; men must agree to take effective contraceptive measures during the study and within 6 months after the end of the study.
Who cannot join
- History of other malignant tumors within 3 years prior to the first administration of the study drug;
- Has multiple factors affecting oral medication;
- Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss;
- Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
- Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;
- Patients who have epilepsy and need treatment or have a history of epileptic seizures, consciousness disorders or unexplained coma within the last 12 months;
Show all 14Show fewer
- Have a history of psychotropic drug abuse and can not quit or have mental disorders;
- Subjects with any severe and / or uncontrolled disease;
- Has known symptomatic central nervous system metastases and/or cancerous meningitis;
- Presence of massive serous pleural/abdominal/pericardial effusion with clinical symptoms or requiring repeated drainage.
- Has participated in other clinical trials within 4 weeks before first dose;
- Receipt of chemotherapy or immunotherapy within 4 weeks before the first administration;, Receipt of radiotherapy or small molecule targeted drugs within 2 weeks, or are still within 5 half-lives of the drugs;
- Receipt of Chinese patent medicines explicitly indicated for anti-tumor use in their drug labels approved by National Medical Products Administration (NMPA) within 2 weeks prior to the first administration;
- According to the judgement of the investigators, Subjects who are at risk of active bleeding during the trial period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, 100021
Bin Li, Doctor, 13801364117, lb87960440@vip.sina.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3217 Tablets in Subjects With Advanced Malignant Tumors
This is the first-in-human clinical study of TQB3217, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3217 in advanced solid tumors, and to preliminarily explore its efficacy in solid tumors.
- Conditions
- Advanced Cancer
- Being tested
- TQB3217Tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3217TabletsDrug
TQB3217 Tablets are ubiquitin specific peptidase 1(USP1)-t inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQB3217Tablets | Experimental | TQB3217 Tablets: Administer once daily, recommended to be taken orally on an empty stomach in the morning at a fixed time, continuously, with each 21-day period as one treatment cycle. Receives: Drug: TQB3217Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Maximum tolerated dose (MTD)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Measured: At the end of Cycle 1 (each cycle is 21 days)
Recommended Phase II Dose (RP2D)
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3217 tablets in adult patients with advanced malignant cancer.
Measured: Baseline up to 24 months
Secondary outcomes (12)
Numbers of participant with Adverse events (AEs) and serious adverse events (SAEs)
The incidence and severity of AEs and SAEs, as well as abnormal laboratory test indicators.
Measured: 30 days after the last administration
Time to Reach the Maximum Plasma Concentration (Tmax)
To characterize the pharmacokinetics of TQB3217 by assessment of time to reach maximum plasma concentration after single and multiple dosing.
Measured: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Peak concentration (Cmax)
The maximum observed plasma concentration of TQB3217 tablets.
Measured: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Half-life (t1/2)
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Area under the concentration-time curve (AUC [0-infinity]
To characterize the pharmacokinetics of TQB3217 by assessment of area under the plasma concentration time curve from 0 extrapolated to infinity.
Measured: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Area under the concentration-time curve (AUC [0-t]
To characterize the pharmacokinetics of TQB3217 by assessment of area under the plasma concentration time curve from the first dose to a certain time point.
Measured: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Apparent clearance (CL/F)
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.
Measured: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Apparent Volume of Distribution during the Terminal Phase
Apparent volume of distribution during the Terminal Phase of the TQB3217 in plasma.
Measured: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Objective Response Rate (ORR)
The percentage of complete response (CR) plus partial response (PR) assessed by Response Evaluation Criteria In Solid Tumors (RECIST) v1.1 criteria.
Measured: Up to 2 years
Disease control rate (DCR)
Defined as the proportion of subjects with Complete Response (CR), Partial Response (PR), or Stable Disease (SD).
Measured: Up to 2 years
Duration of Response (DOR)
Defined as the time from first documented response to documented disease progression.
Measured: Up to 2 years
Overall Survival (OS)
the time from start of study treatment to date of death due to any cause.
Measured: From start of study treatment up to die ，estimated at two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced 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
- 40 participants (estimated)
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
- NCT07291050
- Sponsor's protocol ID
- TQB3217-I-01
- Status last verified
- Sep 2025
- First submitted
- 7 Dec 2025
- Last updated
- 18 Dec 2025
- 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 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3217 Tablets in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07291050
- Acronym / sponsor ID
- TQB3217-I-01
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 18 Dec 2025 (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 is the first-in-human clinical study of TQB3217, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3217 in advanced solid tumors, and to preliminarily explore its efficacy in solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TQB3217Tablets | Experimental | Drug: TQB3217TabletsTQB3217 Tablets: Administer once daily, recommended to be taken orally on an empty stomach in the morning at a fixed time, continuously, with each 21-day period as one treatment cycle. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study;
- Gender is not restricted; Age: 18 to 75 years old; an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1; expected survival period ≥ 3 months;
- Patients with histologically or cytologically confirmed advanced malignant solid tumors that have failed standard treatment (disease progression or intolerance) or for which there is no standard treatment plan;
- The main organs function well;
- Women of childbearing age should take effective contraceptive measures during the study and within 6 months after the end of the study; serum or urine pregnancy test must be negative within 7 days before enrollment, and they must be non-lactating subjects; men must agree to take effective contraceptive measures during the study and within 6 months after the end of the study.
Key exclusion criteria (14 listed)
- History of other malignant tumors within 3 years prior to the first administration of the study drug;
- Has multiple factors affecting oral medication;
- Unalleviated toxicity ≥ grade 1 above CTCAE v5.0 due to any previous therapy, excluding hair loss;
- Major surgical treatment, open biopsy and obvious traumatic injury were performed within 28 days before the study, or have not fully recovered from previous surgery, or are expected to require major surgical surgery during the study period;
- Arteriovenous thrombotic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism;
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 |
|---|---|---|
| TQB3217TabletsTQB3217 Tablets are ubiquitin specific peptidase 1(USP1)-t inhibitor. | Drug | TQB3217Tablets |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
DLT refers to occurrence of drug-related adverse events within the first treatment cycle after subjects receive single-dose or multiple-dose treatment, as defined by the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 toxicity assessment criteria.
Maximum tolerated dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 21 days)
MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.
Recommended Phase II Dose (RP2D)
Time frame: Baseline up to 24 months
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3217 tablets in adult patients with advanced malignant cancer.
12 secondary outcomes
Numbers of participant with Adverse events (AEs) and serious adverse events (SAEs)
Time frame: 30 days after the last administration
Time to Reach the Maximum Plasma Concentration (Tmax)
Time frame: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Peak concentration (Cmax)
Time frame: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Half-life (t1/2)
Time frame: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Area under the concentration-time curve (AUC [0-infinity]
Time frame: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Area under the concentration-time curve (AUC [0-t]
Time frame: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Apparent clearance (CL/F)
Time frame: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Apparent Volume of Distribution during the Terminal Phase
Time frame: Single dose day 1: pre-dose, at 0.5, 1, 1.5，2, 3, 4, 6, 8, 12, 24, 48, 72 hours post dose. Days 7, 14 and 21 of multiple dosing cycle 1: pre-dose. Day 21 of multiple dosing cycle 1: at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24 hours post dose (21 days a cycle)
Objective Response Rate (ORR)
Time frame: Up to 2 years
Disease control rate (DCR)
Time frame: Up to 2 years
Duration of Response (DOR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: From start of study treatment up to die ，estimated at two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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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.
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 TQB3217Tablets in people with Advanced 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 5 inclusion and 14 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 18 Dec 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 Bin Li, Doctor (13801364117, lb87960440@vip.sina.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: At the end of Cycle 1 (each cycle is 21 days)). 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?
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 18 Dec 2025.