A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TQB3122 Capsules in Subjects With Advanced Malignant Tumors

January 27, 2026 updated by: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100050
        • Not yet recruiting
        • Beijing Friendship hospital, Capital Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350014
        • Recruiting
        • Fujian Cancer Hospital
        • Contact:
    • Guangdong
      • Meizhou, Guangdong, China, 514031
        • Not yet recruiting
        • Meizhou People's Hospital (Meizhou Academy of Medical Sciences)
        • Contact:
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200072
        • Not yet recruiting
        • Shanghai Tenth People's Hospital
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Not yet recruiting
        • Sichuan Cancer Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQB3122 Capsules
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.
Drug: TQB3122 Capsules
TQB3122 Capsules is a poly(ADP - ribose) polymerase 1 (PARP1) -targeted inhibitor.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of Cycle 1 (each cycle is 28).
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.
At the end of Cycle 1 (each cycle is 28).
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.
Baseline up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate (DCR)
Time Frame: Up to 2 years
Defined as the proportion of subjects with complete response (CR), partial response (PR), or Stable Disease (SD).
Up to 2 years
Overall Survival (OS)
Time Frame: Baseline up to die, estimated one year
From randomization to the time of death from any cause.
Baseline up to die, estimated one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

November 26, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

January 28, 2026

Last Update Submitted That Met QC Criteria

January 27, 2026

Last Verified

October 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • TQB3122-I-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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