Advanced CancerPhase 1NCT07269145
A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant Tumors
A Phase 1 study testing TQB3122 Capsules in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 sites in China.
Trial summary
This is the first-in-human clinical study of TQB3122, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3122 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?
- TQB3122 Capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 5 sitesChina
- Study dates
- 22 Jan 2026to 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
- The subject voluntarily participates in this study, signs the informed consent form, and has good compliance;
- Gender is not restricted; age (calculated as of the date of signing the informed consent form): 18-75 years old;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; expected survival period ≥ 3 months;
- Patients with histologically or cytologically confirmed advanced malignant solid tumors, including but not limited to epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer, prostate cancer, etc.;
- Advanced solid tumors that have failed standard treatment (disease progression or intolerance) or for which there is no standard treatment plan;
- For Phase Ib (dose expansion stage), except for patients receiving maintenance treatment for ovarian cancer/fallopian tube cancer/primary peritoneal cancer, other patients are required to have target lesions meeting the RECIST 1.1 criteria. For Phase Ia (dose escalation stage), measurable lesions are not required;
- Good function of major organs;
- Women of childbearing age must agree to use 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 use 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;
- Failure to recover from toxicity and/or complications of previous interventions to CTCAE ≤ Grade 1;
- Risk of bleeding;
- Arterial thrombotic events occurring within 6 months prior to the first administration;
- Suffering from ≥ Grade 2 myocardial ischemia or myocardial infarction, supraventricular or ventricular arrhythmias, and ≥ Grade 2 congestive heart failure; poorly controlled blood pressure;
- History of psychotropic substance abuse with inability to abstain, or presence of mental disorders; patients with epilepsy requiring treatment; or patients with severe mental or neurological diseases;
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- Active or uncontrolled severe infections;
- Active syphilis; HIV infection or other immunodeficiency diseases; active hepatitis B or active hepatitis C;
- Complicated with moderate to severe pulmonary diseases that significantly affect respiratory function;
- Patients with active autoimmune diseases requiring systemic treatment (e.g., disease-modifying drugs, corticosteroids, or immunosuppressants);
- Receipt of systemic treatment with prednisone > 10 mg/day or equivalent drugs, or any other form of immunosuppressive therapy within 2 weeks prior to administration;
- History of organ transplantation (except corneal transplantation), allogeneic or autologous hematopoietic stem cell transplantation;
- Poorly controlled diabetes mellitus;
- Patients with leptomeningeal (including arachnoid and pia mater) metastases;
- Known central nervous system (CNS) involvement;
- Presence of massive serous cavity (pleural, peritoneal, or pericardial) effusions requiring repeated drainage to relieve clinical symptoms, or receipt of therapeutic serous cavity effusion drainage within 2 weeks prior to treatment;
- Current intestinal obstruction;
- Known allergy to the components of the study drug;
- Receipt of anti-tumor treatments such as radiotherapy, chemotherapy, targeted therapy, or immunotherapy within 4 weeks prior to the first administration;
- 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 investigator's judgment, subjects with concomitant diseases that severely endanger their safety or affect the completion of the study, or those deemed unsuitable for enrollment for other reasons.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Not yet recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Qin Li, Doctor, 13701288153, qinli128003@163.com
- Not yet recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Guonan Zhang, Doctor, 13881866599, zhanggn@hotmail.com
- Recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yang Sun, Doctor, 15959028989, doctorsunyang@sina.com
- Not yet recruiting
Meizhou People's Hospital (Meizhou Academy of Medical Sciences)
Meizhou, Guangdong, 514031
Yibiao Chen, Bachelor, 13751962821, cybhtyy812@163.com
- Not yet recruiting
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality, 200072
Xiaojun Chen, Doctor, 13601680784, cxjlhjj@163.com
About this study
This is the first-in-human clinical study of TQB3122, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3122 in advanced solid tumors, and to preliminarily explore its efficacy in solid tumors.
- Conditions
- Advanced Cancer
- Being tested
- TQB3122 Capsules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB3122 CapsulesDrug
TQB3122 Capsules is a poly(ADP - ribose) polymerase 1 (PARP1) -targeted inhibitor.
| Study group | Role | What they receive |
|---|---|---|
| TQB3122 Capsules | Experimental | TQB3122 Capsules: Administer once daily, recommended to be taken orally on an empty stomach in the morning at a fixed time, continuously, with each 28-day period as one treatment cycle. Receives: Drug: TQB3122 Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI Common Terminology Criteria for Adverse Events(CTCAE) version5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.
Measured: At the end of Cycle 1 (each cycle is 28).
Maximum tolerated dose (MTD)
MTD was 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 28).
Recommended Phase II Dose (RP2D)
DLT describes side effects of a drug or other treatment that are serious enough to evaluate RP2D of TQB3122 capsules in adult patients with Breast cancers.
Measured: Baseline up to 24 months
Secondary outcomes (2)
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
Overall Survival (OS)
From randomization to the time of death from any cause.
Measured: Baseline up to die, estimated one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start22 Jan 2026
- 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
- 86 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
- NCT07269145
- Sponsor's protocol ID
- TQB3122-I-01
- Status last verified
- Oct 2025
- First submitted
- 26 Nov 2025
- Last updated
- 28 Jan 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 28 Jan 2026. 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 TQB3122 Capsules in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT07269145
- Acronym / sponsor ID
- TQB3122-I-01
- Conditions
- Advanced Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Jan 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 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 TQB3122, aiming to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3122 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 |
|---|---|---|
| TQB3122 Capsules | Experimental | Drug: TQB3122 CapsulesTQB3122 Capsules: Administer once daily, recommended to be taken orally on an empty stomach in the morning at a fixed time, continuously, with each 28-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 (8 listed)
- The subject voluntarily participates in this study, signs the informed consent form, and has good compliance;
- Gender is not restricted; age (calculated as of the date of signing the informed consent form): 18-75 years old;
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; expected survival period ≥ 3 months;
- Patients with histologically or cytologically confirmed advanced malignant solid tumors, including but not limited to epithelial ovarian cancer, fallopian tube cancer, primary peritoneal cancer, breast cancer, prostate cancer, etc.;
- Advanced solid tumors that have failed standard treatment (disease progression or intolerance) or for which there is no standard treatment plan;
Key exclusion criteria (21 listed)
- History of other malignant tumors within 3 years prior to the first administration of the study drug;
- Failure to recover from toxicity and/or complications of previous interventions to CTCAE ≤ Grade 1;
- Risk of bleeding;
- Arterial thrombotic events occurring within 6 months prior to the first administration;
- Suffering from ≥ Grade 2 myocardial ischemia or myocardial infarction, supraventricular or ventricular arrhythmias, and ≥ Grade 2 congestive heart failure; poorly controlled blood pressure;
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 |
|---|---|---|
| TQB3122 CapsulesTQB3122 Capsules is a poly(ADP - ribose) polymerase 1 (PARP1) -targeted inhibitor. | Drug | TQB3122 Capsules |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: At the end of Cycle 1 (each cycle is 28).
DLT will be defined as toxicities that meet pre-defined severity criteria(according to the NCI Common Terminology Criteria for Adverse Events(CTCAE) version5.0 toxicity assessment criteria), and assessed as having a suspected relationship to study drug that occurred from the first dose to the end of the first treatment cycle.
Maximum tolerated dose (MTD)
Time frame: At the end of Cycle 1 (each cycle is 28).
MTD was 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 TQB3122 capsules in adult patients with Breast cancers.
2 secondary outcomes
Disease control rate (DCR)
Time frame: Up to 2 years
Overall Survival (OS)
Time frame: Baseline up to die, estimated one year
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 28 Jan 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TQB3122 Capsules in people with Advanced Cancer, run by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. at 5 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 8 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 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 Yang Sun, Doctor (15959028989, doctorsunyang@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 28).). 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 28 Jan 2026.