Clinical trial NCT06115902: A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer
Official title: A Phase 1 Clinical Trial of TQB2102 for Injection in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) -Expressing Relapsed/Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-11-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: TQB2102 is an antibody-drug conjugate comprised of a humanised antibody against Human Epidermal Growth Factor Receptor 2 (HER2), an enzyme-cleavable linker, and a topoisomerase I inhibitor payload, which combine the ability of antibodies to specifically target tumour cells with the highly potent killing activity of drugs with payloads too toxic for systemic administration. This is a Phase 1/Phase 2 study to evaluate the effectiveness, safety, pharmacokinetics (PK) and anti-drug antibody (ADA) of TQB2102 for injection in subjects with HER2-expressing relapsed/metastatic breast cancer.


Eligibility criteria: Inclusion Criteria:

* Subjects voluntarily participate in this study and sign informed consent;
* Between the ages of 18-75 years (subject to the date of signing the informed consent); Eastern cooperative oncology group (ECOG) score 0-1; estimated survival time ≥3 months;
* Breast cancer patients diagnosed with HER2 expression by pathological examination, with evidence of local focal recurrence or distant metastasis, are not suitable for surgery or radiotherapy for cure;
* Disease progression or intolerance during or after the most recent treatment period must be present before participating in clinical trials;
* At least one measurable lesion (based on Response Evaluation Criteria In Solid Tumors 1.1);
* The main organs function are normally;
* Female participants of childbearing age should agree to use contraception during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male participants should agree that contraception must be used during the study period and for 6 months after the end of the study period.

Exclusion Criteria:

* Concomitant disease and medical history:

  1. Has diagnosed and/or treated additional malignancy within 3 years prior to first administration of study drug;
  2. Adverse effects due to any prior treatment have not been restored according to CommonTerminology Criteria for Adverse Events (CTCAE) 5.0 ≤ level 1 (Excluding hair loss);
  3. Major surgical treatment, incision biopsy, or significant traumatic injury received within 28 days prior to study treatment;
  4. Long-term unhealed wounds or fractures;
  5. Patients who have a prior history of interstitial lung disease/pneumonia requiring steroid intervention, or who are present with interstitial lung disease/pneumonia, or who are suspected of having interstitial lung disease/pneumonia on screening imaging and cannot be ruled out;
  6. Arterial/venous thrombosis events, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism, occurred within 6 months before the first medication;
  7. Patients who have a history of psychotropic substance abuse and are unable to abstain or have mental disorders;
  8. Patients with any severe and/or uncontrolled disease;
* Tumor related symptoms and treatment:

  1. Patients who have been treated with other antitumor drug, such as chemotherapy, radical radiotherapy, or immunotherapy, within 4 weeks prior to the first dose, or who are still within 5 half-lives of the drug;
  2. Received Chinese patent drugs with anti-tumor indications specified in the National Medical Products Administration (NMPA) approved drug instructions within 2 week before the study treatment;
  3. Patients whose imaging shows that the tumor has invaded important blood vessels or who are determined by the investigators to be highly likely to invade important blood vessels during follow-up studies and cause fatal major bleeding;
  4. Uncontrolled pleural effusion, ascites, and moderate or higher pericardial effusion requiring repeated drainage;
  5. Known presence of cancerous meningitis or clinically active central nervous system metastasis; Patients who have been stable for at least 4 weeks after treatment and have been off corticosteroids for at least 2 weeks are excluded;
  6. Patients with severe bone injury due to tumor bone metastasis;
* Study treatment related: people who are known to be allergic to the study drug or its excipients, or to humanized monoclonal antibody products;
* Patients who participated in and used other anti-tumor clinical trials within 4 weeks before the first medication;
* In the judgment of the investigator, there is a situation that seriously endangers the safety of the subjects or affects the completion of the study.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: Baseline up to 10 months.
Secondary outcomes:
measure: Progression-Free Survival (PFS)
timeFrame: Baseline up to 14 months.
measure: Duration of Remission (DOR)
timeFrame: Baseline up to 14 months.
measure: Disease Control Rate (DCR)
timeFrame: Baseline up to 10 months.
measure: Clinical Benefit Rate (CBR)
timeFrame: Baseline up to 14 months.
measure: Overall Survival (OS)
timeFrame: Baseline up to 20 months.
measure: Incidence of adverse event (AE)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
measure: Severity of adverse event (AE)
timeFrame: From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
measure: Concentration of TQB2102
timeFrame: 0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.
measure: Concentration of total antibody
timeFrame: 0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.
measure: Small molecule toxin
timeFrame: 0 to 1 hour before infusion and 0.5 to 2 hours after infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 and Cycle 7 Day 1. Each cycle is 21 days.
measure: Anti-drug antibody (ADA)
timeFrame: Before infusion on Cycle 1 Day 1, Cycle 2 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, Cycle 12 Day 1, 30 days after the end of the last infusion. Each cycle is 21 days.
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Pronvincial Cancer Hospital
state: Anhui
city: Lu'an
country: China
facility: Lu'an People's Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Chongqing
country: China
facility: Chongqing University Cancer Hospital
state: Chongqing
city: Guangzhou
country: China
facility: Sun Yat-Sen University Cancer Center
state: Guangdong
city: Jiangmen
country: China
facility: Jiangmen Central Hospital
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Ganzhou
country: China
facility: Ganzhou People's Hospital
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institute
state: Liaoning
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Cancer Hospital Affiliated to Shandong First Medical University
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine
state: Shannxi
city: Taiyuan
country: China
facility: Shanxi Cancer Hospital
state: Shanxi
city: Suining
country: China
facility: Suining Central Hospital
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: