A Study of TQB2102 for Injection in Patients With Recurrent/Metastatic Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06115902
• Other study ID #: TQB2102-Ib-01
• Status: Recruiting
• Phase: Phase 1
• Start date: November 17, 2023
• Est. completion date: December 2026

Study information

• Verified date: October 2023
• Source: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
• Contact: Qingyuan Zhang, Doctor
• Phone: +86 13312612989
• Email: 13313612989[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• TQB2102 for injection
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Jilin Cancer Hospital	Changchun	Jilin
China	Hunan Cancer Hospital	Changsha	Hunan
China	Chongqing University Cancer Hospital	Chongqing	Chongqing
China	Ganzhou People's Hospital	Ganzhou	Jiangxi
China	Sun Yat-Sen University Cancer Center	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Anhui Pronvincial Cancer Hospital	Hefei	Anhui
China	Jiangmen Central Hospital	Jiangmen	Guangdong
China	Cancer Hospital Affiliated to Shandong First Medical University	Jinan	Shandong
China	Linyi Cancer Hospital	Linyi	Shandong
China	Lu'an People's Hospital	Lu'an	Anhui
China	Guangxi Medical University Cancer Hospital	Nanning	Guangxi
China	Liaoning Cancer Hospital & Institute	Shenyang	Liaoning
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Suining Central Hospital	Suining	Sichuan
China	Shanxi Cancer Hospital	Taiyuan	Shanxi
China	Tianjin Medical University Cancer Institute & Hospital	Tianjin	Tianjin
China	The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	ORR defined as percentage of participants achieving complete response (CR) and partial response (PR).	Baseline up to 10 months.
Secondary	Progression-Free Survival (PFS)	PFS defined as the time from the first injection until the first documented progressive disease (PD) or death from any cause, whichever happens first.	Baseline up to 14 months.
Secondary	Duration of Remission (DOR)	DOR defined as the time when the participants first achieved complete or partial remission to disease progression.	Baseline up to 14 months.
Secondary	Disease Control Rate (DCR)	Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD).	Baseline up to 10 months.
Secondary	Clinical Benefit Rate (CBR)	Percentage of participants achieving complete response (CR), partial response (PR) and stable disease (SD) for = 24 weeks.	Baseline up to 14 months.
Secondary	Overall Survival (OS)	OS defined as the time from the first injection to death from any cause.	Baseline up to 20 months.
Secondary	Incidence of adverse event (AE)	The occurrence of all adverse medical events after the first injection.	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Secondary	Severity of adverse event (AE)	The severity of all adverse medical events after the first injection.	From the date of signing the informed consent to 28 days after the last dosing or a new anti-tumor treatment, whichever comes first.
Secondary	Concentration of TQB2102	Serum concentration of TQB2102	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.
Secondary	Concentration of total antibody	Total antibody concentration in serum	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.
Secondary	Small molecule toxin	Small molecule toxin in plasma	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.
Secondary	Anti-drug antibody (ADA)	Incidence of anti-drug antibody (ADA)	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.