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Efficacy and Safety of Tinengotinib Tablets Combined With Fulvestrant Injection in Patients With HR Positive and HER-2 Negative Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment Phase 2 94 Combination Therapy

Recruiting
Clinical Trial NCT07498478 is designed to study Treatment for Breast Cancer. It is a Phase 2 interventional study that is recruiting, having started on 17 March 2026, with plans to enroll 94 participants. Led by TransThera Sciences (Nanjing), Inc., it is expected to complete by 31 December 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary

The goal of this clinical trial is to learn if tinengotinib combined with fulvestrant works to treat patients with HR-Positive and HER-2-Negative or low-expressing advanced breast cancer. It will also learn about the safety of combination therapy. The main questions it aims to answer are:

  1. Does tinengotinib combined with fulvestrant reduce the tumor burden in participants?
  2. What medical problems do participants ...
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Official Title

A Phase II, Open-Label, Multicenter Clinical Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of TT-00420 (Tinengotinib) Tablets Combined With Fulvestrant Injection in Patients With Hormone Receptor-Positive (HR+) and Human Epidermal Growth Factor Receptor 2 (HER-2) Negative or Low-Expressing Recurrent or Metastatic Breast Cancer Who Have Failed Prior Treatment

Conditions
Breast Cancer
Other Study IDs
  • TT00420CN15
NCT ID Number
NCT07498478
Start Date (Actual)
2026-03-17
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-12-31
Enrollment (Estimated)
94
Study Type
Interventional
PHASE
Phase 2
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalPart B (combination therapy)
Tinengotinib at the optimal dose combined with Fulvestrant
Participants will receive tinengotinib at the optimal dose once daily with fulvestrant in 28-day cycles per protocol defined schedule.
ExperimentalPart B (monotherapy therapy)
Tinengotinib
Participants will receive tinengotinib once daily in 28-day cycles per protocol defined schedule.
ExperimentalPart A (dose optimization)
tinengotinib combined with fulvestrant
Participants will take tinengotinib at the starting dose of 10 mg once daily with fulvestrant to determine the optimal dose of tinengotinib in combination with fulvestrant. If not tolerated, the dose of tinengotinib will be reduced to 8 mg or 6 mg once daily.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Part A: safety evaluation parameters
Including incidence, duration, and severity of DLTs and treatment-related adverse events (TRAEs)
From signing of the informed consent until 28 days after the last dose or the end of the study (whichever occurs first), an average of 1 year.
Part B: Objective Response Rate (ORR) (RECIST v1.1)
The proportion of subjects who achieved a complete response (CR) or a partial response (PR) based on RECIST version 1.1.
From first study drug administration to the end of treatment, an average of 1 year.
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
  1. Histologically or cytologically confirmed breast cancer with evidence of local recurrence or distant metastasis and no indication for surgery or radiotherapy;
  2. Breast cancer confirmed as HR+/HER2- negative or low expression by local laboratory testing based on the most recent tumor tissue sample (from either the primary or metastatic site, excluding bone lesions). HR-positive, HER2-negative or low expression as defined in this study refer to the Chinese Society of Clinical Oncology \[CSCO\] 2024 criteria;
  3. Participants must meet at least one of the following criteria: a) prior bilateral oophorectomy, or age ≥60 years; b) age <60 years, with natural amenorrhea (in the absence of medication or pathological conditions) for ≥12 months, and estradiol and FSH levels within the postmenopausal range; c) age <60 years, currently undergoing ovarian suppression therapy (e.g., LHRH agonist) and requiring continued treatment during the study, with estradiol and FSH levels maintained within the postmenopausal range;
  4. Participants who have previously failed 1-2 lines of endocrine therapy (including AI, SERD, and SERM) for recurrent or metastatic disease are eligible. Subjects with initial diagnosis showing weak ER positivity by IHC (tumor cells with nuclear staining accounting for 1%-10%) are not eligible for enrollment;
  5. Participants must have experienced disease progression after prior treatment with at least one CDK4/6 inhibitor (CDK4/6i), including in the neoadjuvant, adjuvant, or systemic treatment settings;
  6. Participants who have previously failed 0-2 lines of systemic chemotherapy (cytotoxic drugs) for recurrent or metastatic disease. Antibody-drug conjugates (ADCs) are not counted as systemic chemotherapy;
  7. ECOG ≤ 1;
  8. Participants must meet at least one of the following criteria (per RECIST v1.1): a) At least one measurable lesion as defined by RECIST v1.1 at baseline; if the only target lesion is a non-nodal lesion, its longest diameter must be ≥15 mm; b) When bone lesions are the only measurable lesions, lytic or mixed bone lesions may be selected as target lesions; subjects with only blastic bone lesions are not eligible for enrollment.
  9. Adequate organ and bone marrow function;
  10. Premenopausal participants receiving ovarian suppression therapy must agree to use adequate contraception to avoid pregnancy during the study and for at least 3 months after the end of treatment;
  11. Able to sign informed consent and comply with the protocol.

  1. Participants who are pregnant or breastfeeding;
  2. Conditions judged by the investigator as making the participant unsuitable for study drug treatment, including but not limited to: a history of severe allergy to the components or excipients of the study drug, prior treatment history with the study drug, or presence of complications that may be life-threatening in the short term (such as pleural, pericardial, or abdominopelvic effusions that cannot be controlled by drainage or other methods);
  3. Uncontrolled hypertension (systolic blood pressure >150 mmHg or diastolic blood pressure >100 mmHg), allowing for the lowest value from up to two repeat measurements;
  4. Participants with brain or central nervous system (CNS) metastases that have progressed as confirmed by imaging or clinically within 28 days before the start of treatment (e.g., evidence of new or enlarging brain metastases on imaging, new neurological symptoms attributable to brain/CNS metastases);
  5. Participants with concurrent other malignancies or hematologic malignancies that are progressing or require active treatment (excluding basal cell carcinoma of the skin, other non-invasive or indolent malignancies, or cured tumors); Hormone replacement therapy is permitted (e.g., thyroxine replacement therapy post-thyroidectomy);
  6. Participants who have received systemic treatment with corticosteroids (>10 mg/day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive medications within 14 days prior to the initiation of the study drug;
  7. Participants who have received other systemic anti-tumor therapies or treatment with investigational drugs prior to the initiation of the study drug, with a washout period of approximately 5 half-lives or 14 days, whichever is shorter;
  8. Participants who have received extensive radiotherapy or major surgery within 4 weeks prior to the initiation of the study drug, or local palliative radiotherapy within 2 weeks. (If the investigator judges that this does not pose an additional safety risk, initiation of the study drug during the washout period may be permitted with sponsor agreement.)
  9. Participants who have not yet recovered from adverse events resulting from prior anti-tumor therapy (excluding adverse events ≤ Grade 1 per CTCAE, or ≤ Grade 2 adverse events that the investigator judges do not pose a safety risk).
  10. History of severe cardiac or cerebrovascular disease;
  11. Participants who have severe gastrointestinal disease or gastrointestinal dysfunction that may lead to absorption, metabolism or excretion of the study drug, enrollment eligibility will be based on the investigator's judgment (including but not limited to total gastrotomy, short bowel syndrome).
  12. Participants who have bleeding disorders or thrombotic disorders or therapeutic anticoagulant therapy requiring INR monitoring.
  13. Participants who have received a strong CYP3A inhibitor and inducer before starting the study drug, within an interval of ≤ 2 weeks or 5 half-lives (whichever is shorter);
  14. Tested positive for the human immunodeficiency virus (HIV);
  15. Participants with active HBV infection and/or HCV infection;
  16. Participants who are unable to swallow or tolerate oral medication.
  17. The investigator determines that there are other reasons making the participant unsuitable for participation in the study.
TransThera Sciences (Nanjing), Inc. logoTransThera Sciences (Nanjing), Inc.
Study Central Contact
Contact: Caixia Sun, 025-58216298, [email protected]
13 Study Locations in 1 Countries

Guangdong

Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Kun Wang, MD, Contact
Not yet recruiting

Hubei

Zhongnan Hospital of Wuhan University, Wuhan, Hubei, China
Haijun Yu, MD, Contact
Not yet recruiting

Hunan

Hunan Cancer Hospital, Changsha, Hunan, China
Quchang Ouyang, MD, Contact
Not yet recruiting

Jiangsu

Jiangsu Province Hospital, Nanjing, Jiangsu, China
Yongmei Yin, MD, Contact
Not yet recruiting

Shandong

Shandong Cancer Hospital, Jinan, Shandong, China
Huihui Li, MD, Contact
Not yet recruiting
Linyi Cancer Hospital, Linyi, Shandong, China
Guozhu Liu, MD, Contact
Recruiting

Zhejiang

Zhejiang Cancer Hospital, Hangzhou, Zhejiang, China
Hai Hu, MD, Contact
Not yet recruiting
Cancer Hospital, Chinese Academy of Medical Sciences, Beijing, 100021, China
Binghe Xu, MD, Contact
Recruiting
Beijing Cancer Hospital, Beijing, China
Huiping Li, MD, Contact
Not yet recruiting
The First Medical Center, Chinese PLA General Hospital, Beijing, China
Weihong Zhao, MD, Contact
Not yet recruiting
Southwest Hospital, Chongqing, China
Yi Zhang, MD, Contact
Not yet recruiting
Fudan University Shanghai Cancer Center, Shanghai, China
Hongxia Wang, MD, Contact
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital, Tianjin, China
Zhongsheng Tong, MD, Contact
Not yet recruiting