Advanced Solid Tumors
Conditions
Brief summary
The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with or without Antitumor Therapy in Advanced Solid Tumors. To explore the reasonable dosage of SHR-A2102 for Advanced Solid Tumors.
Interventions
DRUGSHR-A2102
SHR-A2102
SHR-A2102 + Adebrelimab injection
DRUGSHR-A2102 + Disitamab Vedotin For Injection
SHR-A2102 + Disitamab Vedotin For Injection
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Have the ability to give informed consent, have signed informed and able to comply with the treatment plan to visit the tests and other procedural requirements； 2. The age of signing the informed consent is above 18 years old, regardless of gender; for the SHR-A2102 combined with Disitamab Vedotin cohort, the maximum upper limit was 80 years old 3. The ECOG score is 0 or 1； 4. Expected survival ≥12 weeks 5. Subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors, stage Ib subjects who have failed standard treatment; Stage II subjects with pathologically confirmed locally advanced unresectable or metastatic solid tumors without systemic antitumor therapy； 6. Provide archived or fresh tumor tissue； 7. At least one measurable lesion according to RECIST v1.1 criteria； 8. Good level of organ function； 9. Male subjects whose partners are women of childbearing age and female subjects who are fertile are required to use highly effective contraceptive methods.
Exclusion criteria
1. Inadequately treated central nervous system metastases or the presence of uncontrolled or symptomatic active central nervous system metastases； 2. Have previously received antiboy-coupled drugs containing topoisomerase I inhibitors; Stage II was previously treated with PD-1/PD-L1 inhibitors；For the SHR-A2102 combined with Disitamab Vedotin cohort, those who have previously received Disitamab Vedotin treatment or antibody-drug conjugates containing topoisomerase I inhibitors 3. Systemic antitumor therapy was received 4 weeks before the start of the study； 4. Palliative radiotherapy was completed within 14 days before the first dose; Chest radiotherapy \>30 Gy within 6 months prior to initial administration； 5. Toxicity and/or complications of previous antitumor therapy did not return to NCI-CTCAE level ≤1 or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| RP2D | through phase IB completion, an average of 1 years |
| Incidence and severity of AE； | from Day1 to 90 days after last dose |
| ORR | 18 months after the last subject was enrolled in the group |
Secondary
| Measure | Time frame |
|---|---|
| DCR(Investigator evaluation) | 18 months after the last subject was enrolled in the group |
| DoR(Investigator evaluation) | 18 months after the last subject was enrolled in the group |
| PFS(Investigator evaluation) | 18 months after the last subject was enrolled in the group |
| OS(Investigator evaluation) | 18 months after the last subject was enrolled in the group |
| SHR-A2102 and free toxin PK | through study completion, an average of 2 years |
| SHR-1316 PK | through study completion, an average of 2 years |
| SHR-A2102 Immunogenicity | through study completion, an average of 2 years |
| SHR 1316 Immunogenicity | through study completion, an average of 2 years |
Countries
China
Contacts
CONTACTChi Zhang
Outcome results
None listed