CClinicalTrials.gg
Sign In
Not yet recruitingNCT07291050Updated Dec 18, 2025

A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3217 Tablets in Subjects With Advanced Malignant Tumors

A Phase 1 interventional study of TQB3217Tablets in Advanced Cancer, sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-18.

Sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Cancer
03

In context

Lead sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. is the lead sponsor of 313 studies on the registry; 75 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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;
  • 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    TQB3217Tablets

    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.

    Drug: TQB3217Tablets

Interventions

  • DrugTQB3217Tablets

    TQB3217 Tablets are ubiquitin specific peptidase 1(USP1)-t inhibitor.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the end of Cycle 1 (each cycle is 21 days)

  2. Maximum tolerated dose (MTD)

    MTD is defined as the highest dose at which dose-limiting toxicity (DLT) occurred in less than 33% of patients.

    Time frame: At the end of Cycle 1 (each cycle is 21 days)

  3. 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.

    Time frame: Baseline up to 24 months

Secondary outcomes

  1. 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.

    Time frame: 30 days after the last administration

  2. 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.

    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)

  3. Peak concentration (Cmax)

    The maximum observed plasma concentration of TQB3217 tablets.

    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)

  4. 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.

    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)

  5. 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.

    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)

  6. 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.

    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)

  7. Apparent clearance (CL/F)

    Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the body.

    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)

  8. Apparent Volume of Distribution during the Terminal Phase

    Apparent volume of distribution during the Terminal Phase of the TQB3217 in plasma.

    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)

  9. 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.

    Time frame: Up to 2 years

  10. Disease control rate (DCR)

    Defined as the proportion of subjects with Complete Response (CR), Partial Response (PR), or Stable Disease (SD).

    Time frame: Up to 2 years

  11. Duration of Response (DOR)

    Defined as the time from first documented response to documented disease progression.

    Time frame: Up to 2 years

  12. Overall Survival (OS)

    the time from start of study treatment to date of death due to any cause.

    Time frame: From start of study treatment up to die ，estimated at two years

07

Study locations

1 site
  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    Beijing, Beijing Municipality 100021, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07291050
Lead sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Responsible party
Sponsor
First posted
Dec 18, 2025
Start date
Dec 2025 (estimated)
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Dec 18, 2025

Study contacts

Bin Li, Doctor
Contact
lb87960440@vip.sina.com
13801364117

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Start the discussion