The study consists of two cohorts: Cohort 1 includes patients who failed standard first-line therapy; Cohort 2 includes treatment-naïve patients. Patients will receive treatment with SHR-A1811 and AK112 until disease progression or meeting other criteria for treatment discontinuation, whichever occurs first.
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Signed ICF.
2. Age 18-75.
3. ECOG PS 0-1.
4. Life expectancy ≥3 months.
You may not be if
6. Cohort 1: Failed prior first-line systemic therapy, with HER2 amplification or overexpression . Cohort 2: No prior systemic therapy, with HER2 amplification/overexpression .
7. ≥1 measurable lesion per RECIST 1.1.
8. Adequate organ and bone marrow function.
9. Use of effective contraception.
1. History of ILD, pneumonitis requiring steroids, or active non-infectious pneumonitis.
2. Arterial/venous thrombotic event within 6 months.
3. Significant cardiovascular disease.
4. Active autoimmune disease requiring systemic treatment.
5. Use of systemic immunosuppressants within 2 weeks prior.
