HER2-expressing Advanced Solid Tumors
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A1811 combined with other antitumor therapies in advanced solid tumors. To explore the reasonable dosage of SHR-A1811 combined with other antitumor therapies for advanced solid tumors.
Interventions
DRUGSHR-A1811 combined with Pyrotinib.
SHR-A1811 combined with Pyrotinib
DRUGSHR-A1811 combined with other antitumor therapies
SHR-A1811 combined with other antitumor therapies
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Able and willing to provide a written informed consent. Have good compliance and cooperated with follow-up visits. 2. Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent. Male or female. 3. ECOG score 0-1. 4. Life expectancy is at least 12 weeks. 5. Histologically or cytologically confirmed metastatic or advanced unresectable HER2-expression or Her-2 functional mutations solid tumors. 6. Provide ≥ 6(or ≥8)sections of formalin-fixed, paraffin-embedded tumor tissue blocks or unstained tumor specimen sections. Sections should be archived within 1 year before the first study treatment or freshly obtained (freshly obtained is preferred). 7. ≥1 Measurable lesions, according to the Response Evaluation Criteria for Solid Tumors (RECIST) version 1.1. The dose escalation phase allows for the absence of measurable lesions. 8. Organ function met criteria within 7 days prior to initial administration (No blood component or cell growth factor was used within 14 days before the initial administration): 9. Left ventricular ejection fraction (LVEF) ≥ 50% at baseline within 28 days prior to initial administration. 10. Males and women of childbearing age must use reliable contraception from the written informed consent to 7 months after last drug administration (SHR-A1811) or 8 weeks after last drug administration (Pyrotinib) or 6 months after last drug administration (BP102 or Oxaliplatin or Calcium levonofolinate or fluorouracil), the latest time should be taken as final. Women of childbearing age must have had a pregnancy test (serum or urine) with negative results within 7 days prior to initial administration and must not in lactation period.
Exclusion criteria
1. Subjects with untreated or known active CNS metastasis. Subjects with a history of meningeal metastasis or known active meningeal metastasis. 2. Have a history of antibody drug conjugate with following characteristics: topoisomerase I inhibitors, including Enhertu (DS-8201a), U3-1402, etc. Part A: Have a history of Her-2 targeted tyrosine-kinase inhibitor (TKI). 3. Palliative radiotherapy within 14 days prior to initial administration. Subjects who had received systemic anti-tumor therapy within 4 weeks prior to initial administration will not permitted. The interval between the end of small-molecule targeted drugs administration and initial test drug administration must be ≥ 5 half-lives or 7 days (take the longer time). The interval between the end of Chinese patent anti-tumor drug administration and initial test drug administration must be ≥ 2 weeks. Participating in another clinical study of other drugs. The interval between the previous clinical study drug use and this study initial administration is less than 4 weeks or 5 half-lives of previous clinical study drug (take the shorter time). 4. Toxicity and/or complications of previous interventions were not recovered to NCI-CTCAE ≤ grade 1 or didn't meet this inclusion criteria and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A: Maximally Tolerated Dose (MTD),)(Phase ⅠB). | From the first dose to the last dose, about 11 months |
| Part A: recommended phase 2 dose (RP2D)(Phase ⅠB). | From the first dose to the last dose, about 11 months |
| Part A: Adverse Events (Phase ⅠB) | From the first dose to the last dose, about 11 months |
| Part A: Objective Response Rate (ORR) (Phase Ⅱ) | From the first dose to the last dose, about 11 months |
Secondary
| Measure | Time frame |
|---|---|
| Part A: Overall survival (OS) (Phase ⅠB and Phase Ⅱ) | From the first dose to the last dose, about 13 months |
| Part A: ORR (Phase ⅠB). | From the first dose to the last dose, about 11 months. |
| Part A: Adverse Events (PhaseⅡ). | about 11 months. |
| Part A: Disease Control Rate (DCR) (Phase ⅠB and Phase Ⅱ) | From the first dose to the last dose, about 11 months |
| Part A: Duration of Response (DoR) (Phase ⅠB and Phase Ⅱ) | From the first dose to the last dose, about 11 months |
| Part A: Progression-free survival (PFS) (Phase ⅠB and Phase Ⅱ) | From the first dose to the last dose, about 13 months. |
Countries
China
Contacts
Primary ContactZhengjin Zhang
Outcome results
None listed