Antibody-drug Conjugate Information
General Information of This Antibody-drug Conjugate (ADC)
| ADC ID |
DRG0IVDIV
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| ADC Name |
TQB2102
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| Synonyms |
TQB2102
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| Organization |
Chia Tai Tianqing Pharmaceutical (CTTQ) (Originator)
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| Drug Status |
Phase 3
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| Drug-to-Antibody Ratio |
5.8~6
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| Structure |
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| Antibody Name |
Anti-HER2 antibody
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Antibody Info | ||||
| Antigen Name |
Receptor tyrosine-protein kinase erbB-2 (HER2 ECD2); Receptor tyrosine-protein kinase erbB-2 (HER2 ECD4)
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Antigen Info | ||||
| Payload Name |
2-DDDX-d
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Payload Info | ||||
| Therapeutic Target |
DNA topoisomerase 1 (TOP1)
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Target Info | ||||
| Linker Name |
Mc-Gly-Gly-Phe-Gly
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Linker Info | ||||
| Conjugate Type |
Random Cysteines
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The indication landscape of This ADC(2027 Update)
The clinical trial pipeline of This ADC(2027 Update)
| Indication | Phase 1 | Phase 1/2 | Phase 2 | Phase 2/3 | Phase 3 | New Drug Application | Approved | |||||||||||
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| Biliary tract cancer |
1 Trials
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| Breast cancer |
1 Trials
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3 Trials
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4 Trials
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| Colorectal cancer |
1 Trials
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| Lung cancer |
1 Trials
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| Unspecific solid tumor |
1 Trials
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1 Trials
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General Information of The Activity Data Related to This ADC
Identified from the Human Clinical Data
Full List of Activity Data of This Antibody-drug Conjugate
Identified from the Human Clinical Data
| Experiment 1 Reporting the Activity Date of This ADC | [1] | ||||
| Patients Enrolled |
Eligible participants are HER2+ recurrent/metastatic breast cancer patients (18-75 years, ECOG 0-1) with measurable disease (RECIST 1.1), adequate organ function, and progression after prior therapy. Reproductive-age subjects require contraception for 6 months post-study.
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| Administration Dosage |
Dose: 6.0 mg/kg or 7.5 mg/kg of TQB2102 for injection. Administration: Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06115902 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase 1 Clinical Trial of TQB2102 for Injection in Patients With Human Epidermal Growth Factor Receptor 2 (HER2) -Expressing Relapsed/Metastatic Breast Cancer | ||||
| Primary Endpoint |
Primary efficacy endpoint is ORR (CR+PR rate) assessed over 10 months, with safety monitoring including AE incidence/severity tracked from consent through 28 days post-treatment or new therapy initiation.
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| Other Endpoint |
Secondary outcomes include survival metrics (PFS up to 14 months, OS up to 20 months), disease activity measures (DOR/DCR/CBR), and PK/immunogenicity profiles (TQB2102 concentration, ADA development) evaluated through serial sampling across treatment cycles (21-day intervals).
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| Experiment 2 Reporting the Activity Date of This ADC | [2] | ||||
| Patients Enrolled |
Eligible participants are treatment-naïve HER2+ invasive breast cancer patients (T0-4/N0-3/M0) with ECOG 0-1, adequate organ function, and surgical eligibility post-neoadjuvant therapy. Reproductive-age subjects require contraception for 6 months post-study, confirmed by pregnancy testing.
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| Administration Dosage |
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC), 6.0 mg/kg or 7.0 mg/kg.
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| Related Clinical Trial | |||||
| NCT Number | NCT06198751 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2, Randomized, Open-label, Multicenter Study to Evaluate the Efficacy and Safety of TQB2102 for Injection for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression | ||||
| Primary Endpoint |
Primary endpoints include pathological response rates (tpCR and bpCR) assessed within 12 months, evaluating complete tumor disappearance in breast tissue and lymph nodes, alongside comprehensive AE monitoring (incidence/severity per NCI CTCAE v5.0) from consent through 28 days post-treatment.
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| Other Endpoint |
Secondary outcomes measure efficacy via ORR (12 months), long-term survival (EFS/IDFS up to 60 months tracking recurrence and mortality), and immunogenicity (ADA incidence) through multi-cycle testing (21-day intervals) until 90 days post-treatment
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| Experiment 3 Reporting the Activity Date of This ADC | [3] | ||||
| Patients Enrolled |
Eligible participants are HER2-negative recurrent/metastatic breast cancer patients (18-75 years, ECOG ≤1) with progression after ≥1 line of chemotherapy (or CDK4/6 inhibitors for HR+ cases), measurable lesions (RECIST 1.1), and available tumor samples. Reproductive-age subjects require contraception for 6 months post-study with confirmed negative pregnancy testing.
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| Administration Dosage |
7.5mg/kg TQB2102, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06452706 | Clinical Status | PHASE2 | ||
| Clinical Description | The Phase II Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection in Human Epidermal Growth Factor Receptor 2 (HER2) Negative Recurrent/Metastatic Breast Cancer | ||||
| Primary Endpoint |
Primary efficacy endpoint is ORR (CR+PR rate per RECIST 1.1) assessed over 24 months, with comprehensive safety monitoring including AE incidence tracked for 36 months and ADA development evaluated through multi-cycle testing (21-day intervals) until 30 days post-treatment.
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| Other Endpoint |
Secondary outcomes include survival metrics (PFS up to 36 months, OS up to 48 months), disease activity measures (duration of remission/DCR/CBR), and biomarker analyses (HER2 expression correlation, ctDNA dynamics) all evaluated within 24 months.
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| Experiment 4 Reporting the Activity Date of This ADC | [4] | ||||
| Patients Enrolled |
Eligible participants are treatment-compliant adults (18-75 years, ECOG 0-1) with confirmed unresectable HER2-low breast cancer (HR status documented), radiologically proven progression, ≥1 measurable lesion (RECIST 1.1), and adequate organ function.
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| Administration Dosage |
Administered by intravenous drip, 7.5 mg/kg per dose, 21 days as a treatment cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06561607 | Clinical Status | PHASE3 | ||
| Clinical Description | A Randomized, Open, Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection Versus Investigator-Selected Chemotherapy in HER2 Low-Expressing Recurrent/Metastatic Breast Cancer | ||||
| Primary Endpoint |
The primary endpoint is IRC-assessed PFS (up to 25 months) comparing TQB2102 versus chemotherapy in both HR+/HER2-low and overall HER2-low recurrent/metastatic breast cancer populations.
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| Other Endpoint |
Secondary endpoints include investigator-assessed efficacy measures (PFS/OS/ORR/DOR/CBR) within 25 months, safety monitoring (AE/SAE incidence, lab abnormalities) for 52 months, PK analysis of TQB2102 components during treatment cycles, and ADA immunogenicity assessment at specified intervals.
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| Experiment 5 Reporting the Activity Date of This ADC | [5] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1) must have signed consent, locally advanced HER2+ solid tumors refractory to standard therapy, ≥1 measurable lesion (RECIST 1.1), adequate organ function, and commitment to contraception for 6 months post-treatment.
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| Administration Dosage |
intravenous infuse TQB2102 injection every three weeks, 21 days as a treatment cycle. (1.5mg/kg, 3mg/kg, 4.5mg/kg, 6mg/kg, 7.5mg/kg, 9mg/kg)
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| Related Clinical Trial | |||||
| NCT Number | NCT05735496 | Clinical Status | PHASE1 | ||
| Clinical Description | A Phase I Study of TQB2102 Injection in Patients With Advanced Cancers | ||||
| Primary Endpoint |
Primary endpoints include DLT assessment during first 21-day cycle to determine MTD, with comprehensive AE monitoring (incidence/severity per NCI CTCAE v5.0) from first dose until 28 days post-treatment or new therapy initiation.
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| Other Endpoint |
Secondary outcomes comprise immunogenicity (ADA incidence across treatment cycles), PK parameters (AUC/Cmax/T1/2 for ADC components), and efficacy measures (ORR/DCR/DOR/PFS/OS) evaluated over 2 years per RECIST v1.1 criteria.
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| Experiment 6 Reporting the Activity Date of This ADC | [6] | ||||
| Patients Enrolled |
Eligible subjects (18-75 years, ECOG 0-1) must have histologically confirmed unresectable/metastatic biliary cancer with ≥1 measurable lesion (RECIST 1.1), adequate organ function, failed prior therapy, and reproductive-age patients must use contraception for 6 months post-study.
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| Administration Dosage |
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6/8 cycles.
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| Related Clinical Trial | |||||
| NCT Number | NCT06431490 | Clinical Status | PHASE1|||PHASE2 | ||
| Clinical Description | A Study to Evaluate the Efficacy, Safety, and Immunogenicity of TQB2102 for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Biliary Tract Cancer | ||||
| Primary Endpoint |
Primary endpoints include AE/SAE incidence and severity monitoring from informed consent until 28 days post-treatment, along with RP2D determination within 24 weeks.
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| Other Endpoint |
Secondary efficacy measures (ORR/PFS/DCR/DOR/OS) will be investigator-assessed per RECIST 1.1 over 36 weeks in HER2-positive (IHC 3+ or 2+/ISH+) advanced biliary tract cancer patients.
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| Experiment 7 Reporting the Activity Date of This ADC | [7] | ||||
| Patients Enrolled |
Eligible patients (18-75 years, ECOG 0-1) must have confirmed HER2+ (IHC 3+ or 2+/ISH+) unresectable/metastatic gastroesophageal adenocarcinoma, ≥1 measurable lesion (RECIST 1.1), adequate organ function, and no prior systemic therapy for metastatic disease (except adjuvant/neoadjuvant completed ≥6 months prior). PD-L1 testing capability and contraception use for 6 months post-treatment are required.
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| Administration Dosage |
TQB2102 for injection in combination with benmelstobart every three weeks for a cycle of 21 days
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| Related Clinical Trial | |||||
| NCT Number | NCT06767800 | Clinical Status | PHASE2 | ||
| Clinical Description | Phase II Clinical Trial Evaluating the Efficacy and Safety of TQB2102 for Injection in Chemotherapy With Behmosubstituted Monoclonalb/Pembrolizumab ± Capecitabine in Patients With Unresectable, Locally Advanced, Recurrent, or Metastatic HER2-Positive Gastroesophageal Adenocarcinoma | ||||
| Primary Endpoint |
The primary endpoint is ORR (CR+PR) assessed by both RECIST v1.1 and iRECIST criteria over an average 1-year study period in HER2-positive gastroesophageal adenocarcinoma patients.
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| Other Endpoint |
Secondary endpoints include PFS (average 3 years), DOR (average 1 year), OS (average 3 years), and AE/SAE incidence (CTCAE v5.0) monitored until 28 days post-treatment.
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| Experiment 8 Reporting the Activity Date of This ADC | [8] | ||||
| Patients Enrolled |
Eligible subjects are female (≥18 years, ECOG 0-1) with histologically confirmed recurrent/metastatic gynecologic tumors (excluding IHC 0), ≥1 measurable lesion (RECIST 1.1), and premenopausal women must use high-efficacy contraception (failure rate <1%/year) with negative pregnancy testing at screening.
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| Administration Dosage |
Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle
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| Related Clinical Trial | |||||
| NCT Number | NCT06798207 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2 Clinical Trial of TQB2102 for Injection in the Treatment of Patients With Recurrent/Metastatic Advanced Gynecological Tumors to Evaluate the Safety and Efficacy | ||||
| Primary Endpoint |
The primary endpoint is ORR (CR+PR rate) evaluated over 12 months in patients with HER2-expressing (IHC 1+/2+/3+) advanced gynecologic tumors who failed prior platinum-based chemotherapy.
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| Other Endpoint |
Secondary endpoints include DOR/PFS/DCR (12-month assessment), OS (17-month follow-up), AE frequency/severity monitoring from consent to 28 days post-treatment, and ADA incidence at specified treatment cycles (21-day intervals).
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| Experiment 9 Reporting the Activity Date of This ADC | [9] | ||||
| Patients Enrolled |
Eligible subjects must have histologically confirmed unresectable NSCLC, failed prior therapy, life expectancy ≥3 months, and reproductive-age patients require contraception for 6 months post-study with negative pregnancy testing at screening.
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| Administration Dosage |
TQB2102 for injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle; Benmelstobart injection, intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle.
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| Related Clinical Trial | |||||
| NCT Number | NCT06496490 | Clinical Status | PHASE2 | ||
| Clinical Description | A Phase 2 Clinical Trial of TQB2102 for Injection in Locally Advanced or Metastatic Non-small Cell Lung Cancer With HER2 Gene Abnormality to Evaluate the Efficacy and Safety | ||||
| Primary Endpoint |
Primary endpoint is ORR (CR+PR rate) assessed over 8 months in treatment-refractory NSCLC patients (18-75 years, ECOG 0-1) with measurable lesions (RECIST 1.1).
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| Other Endpoint |
Secondary outcomes include DOR/PFS (8-month assessment), OS (18-month follow-up), AE frequency/severity monitoring until 28 days post-treatment, and ADA incidence at treatment cycles (C1D1-C12D1) plus 90-day follow-up.
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| Experiment 10 Reporting the Activity Date of This ADC | [10] | ||||
| Related Clinical Trial | |||||
| NCT Number | NCT05735496 | Clinical Status | Phase 1 | ||
| Clinical Description | A phase 1 study of TQB2102 injection in patients with advanced cancers. | ||||
References