Clinical trial NCT05735275: A Phase 1 Study of SHR-A2102 in Subjects With Advanced Solid Tumors.
Official title: Safety, Tolerability, Pharmacokinetics, and Efficacy of SHR-A2102, In Subjects With Locally Advanced Or Metastatic Solid Tumor Malignancies: A Phase I Open-Label, One-Arm, Multicenter Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Or Metastatic Solid Tumor Malignancies
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 252
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: open, multicenter, Single Group
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Dose Limited Toxicity (DLT)
timeFrame: 21 Days (first cycle)
measure: Maximum tolerable dose (MTD)
timeFrame: 21 Days (first cycle)
measure: Recommended dose for phase II (RP2D)
timeFrame: Up to 8 months
Secondary outcomes:
measure: Area under the plasma concentration time curve in the dosing interval AUC(TAU) of SHR-A2102
timeFrame: 30 days after last dose
measure: Maximum observed plasma concentration (Cmax) of SHR-A2102
timeFrame: 30 days after last dose
measure: Time of maximum observed plasma concentration (Tmax) of SHR-A2102
timeFrame: 30 days after last dose
measure: Immunogenicity Analysis
timeFrame: 30 days after last dose
measure: ORR
timeFrame: 24 months
measure: DCR
timeFrame: 24 months
measure: DoR
timeFrame: 24 months
measure: PFS
timeFrame: 24 months
measure: OS
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Cancer Hospital
state: Beijing
Study officials:
References: