Evaluating SHR-A2102 for Advanced Solid Tumors

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

This study is testing a new treatment called SHR-A2102 to see if it can help people with advanced solid tumors who haven't had success with other therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06417554 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the safety, tolerability, and efficacy of SHR-A2102, both alone and in combination with antitumor therapy, in patients with advanced solid tumors. The study will explore appropriate dosing of SHR-A2102 and include patients with locally advanced unresectable or metastatic solid tumors who have either failed standard treatments or have not received systemic therapy. Participants will undergo regular assessments to monitor their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with pathologically confirmed advanced solid tumors who have a good level of organ function and can comply with the treatment plan.

Not a fit: Patients with inadequately treated central nervous system metastases may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies have shown promise with similar approaches in treating advanced solid tumors, suggesting potential for success.

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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University Cancer Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: Chi Zhang

Conditions Advanced Solid Tumors