Advanced Or Metastatic Solid Tumor Malignancies
Conditions
Brief summary
This is a first in human, open-label, single-arm, multicenter dose escalation and expansion Phase 1 study of SHR-A2102 in patients with advanced or metastatic solid tumors. The purpose of this study is to assess the tolerability, safety, pharmacokinetics and immunogenicity of SHR-A2102 and preliminary anti-tumor efficacy
Interventions
DRUGSHR-A2102
All participants receive SHR-A2102 alone.
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
open, multicenter, Single Group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to understand and the willingness to sign a written informed consent document； 2. Aged ≥18 years old; 3. Histologically or cytologically confirmed advanced or metastatic malignant tumor; 4. Presence of at least one measurable lesion in agreement to RECIST criteria; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; 6. Life expectancy ≥3 months; 7. Adequate organ performance based on laboratory blood tests; 8. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation.
Exclusion criteria
1. Previous received anti-cancer systemic therapy including chemo-therapy, radiation therapy, target therapy or immuno-therapy within 4 weeks before the first dose; 2. Previous received experimental medication or therapy within 4 weeks before the first dose; 3. Previous therapeutic surgery within 4 weeks; 4. Has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to NCI-CTCAE version 5.0 grade ≤ 1. 5. Known allergic to any compound of SHR-A2102; 6. Patients with uncontrolled or active brain metastasis； 7. Patients with clinical significant lung disease; 8. Patients with history of autoimmune diseases; 9. Known active hepatitis B or C infection; 10. Other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose Limited Toxicity (DLT) | 21 Days (first cycle) |
| Maximum tolerable dose (MTD) | 21 Days (first cycle) |
| Recommended dose for phase II (RP2D) | Up to 8 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum observed plasma concentration (Cmax) of SHR-A2102 | 30 days after last dose | — |
| Time of maximum observed plasma concentration (Tmax) of SHR-A2102 | 30 days after last dose | — |
| Immunogenicity Analysis | 30 days after last dose | ADA |
| PFS | 24 months | Progression-Free-Survival |
| DCR | 24 months | Disease Control Rate |
| DoR | 24 months | Duration of Response |
| ORR | 24 months | Objective Response Rate |
| OS | 24 months | Overall survival |
| Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102 | 30 days after last dose | — |
Countries
China
Contacts
Primary ContactQi Zhang
Outcome results
None listed