Clinical trial NCT06417554: A Trial of SHR-A2102 With or Without Antitumor Therapy in Advanced Solid Tumors
Official title: A Phase IB /II, Multicenter, Open-Label Study of Safety, Tolerability and Efficacy of SHR-A2102 for Injection With or Without Antitumor Therapy in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Lead sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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；
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；
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 exclusion criteria；
6. Systemic immunosuppressive therapy was administered within 14 days prior to the first study；
7. Subjects with known or suspected interstitial pneumonia；
8. ≥ grade 3 immune-related adverse events occurred during previous treatment with immune checkpoint inhibitors；
9. The presence of any active, known, or suspected autoimmune disease；
10. Moderate or severe ascites with clinical symptoms, uncontrolled or moderate or above pleural effusion and pericardial effusion；
11. The presence of clinical cardiac symptoms or diseases that are not well controlled；
12. Any other malignancy diagnosed within the previous 5 years；
13. Subjects who had a severe infection within 28 days prior to the first dose；
14. Active hepatitis B or active hepatitis C；
15. Patients with active tuberculosis infection within 1 year prior to enrollment, or with a history of active tuberculosis infection more than 1 year prior but without formal treatment；
16. History of immune deficiency；
17. Live attenuated vaccines were used within 28 days prior to initial study administration or during the expected study period；
18. Participants who are participating in another clinical study or whose first dose is less than 4 weeks from the end of the previous clinical study (last dose), or five half-lives of the investigational drug, whichever is shorter；
19. Have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; Minor traumatic surgery within 7 days prior to first dosing; Presence of non-healing wounds or untreated fractures；
20. Severe allergic reactions are known to occur in individuals allergic to any component of SHR-A2102, SHR-1316, or other monoclonal antibody/fusion protein drugs；
21. Female subjects who are pregnant or plan to become pregnant during the study period；
22. The presence of uncontrolled mental illness and other conditions known to affect the completion of the study process, such as alcohol, drug or substance abuse, and criminal detention；
23. In the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.

Primary outcomes:
measure: RP2D
timeFrame: through phase IB completion, an average of 1 years
measure: Incidence and severity of AE；
timeFrame: from Day1 to 90 days after last dose
measure: ORR
timeFrame: 18 months after the last subject was enrolled in the group
Secondary outcomes:
measure: DCR(Investigator evaluation)
timeFrame: 18 months after the last subject was enrolled in the group
measure: DoR(Investigator evaluation)
timeFrame: 18 months after the last subject was enrolled in the group
measure: PFS(Investigator evaluation)
timeFrame: 18 months after the last subject was enrolled in the group
measure: OS(Investigator evaluation)
timeFrame: 18 months after the last subject was enrolled in the group
measure: SHR-A2102 and free toxin PK
timeFrame: through study completion, an average of 2 years
measure: SHR-1316 PK
timeFrame: through study completion, an average of 2 years
measure: SHR-A2102 Immunogenicity
timeFrame: through study completion, an average of 2 years
measure: SHR 1316 Immunogenicity
timeFrame: through study completion, an average of 2 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
References: