SG2918 treatment for advanced malignant tumors

A Phase I Clinical Study to Evaluate the Safety Tolerability and Preliminary Efficacy of SG2918 in Subjects With Advanced Malignant Tumors

This study is testing a new treatment called SG2918 to see if it can help people with advanced tumors that don't respond to regular treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 117 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. (Industry-sponsored)
• Drugs / interventions: immunotherapy, prednisone
• Locations: 6 sites (Chongqing, Chongqing and 5 other locations)
• Trial ID: NCT06167486 on ClinicalTrials.gov

What this trial studies

This Phase I, open-label study evaluates the safety, tolerability, and preliminary efficacy of SG2918 in patients with advanced malignant tumors that are resistant to standard therapies or for which no standard treatment is available. The study employs a dose escalation approach, administering SG2918 at increasing doses from 0.1 mg/kg to 3 mg/kg, followed by a dose expansion in specific tumor types. Patients will receive treatment every three weeks until disease progression or intolerable toxicity occurs.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced malignant tumors that have not responded to standard therapies and who meet specific eligibility criteria.

Not a fit: Patients with active central nervous system metastases or significant cardiovascular conditions 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 malignant tumors who have limited or no available treatments.

How similar studies have performed: Other studies have shown promise with similar dose escalation approaches in treating advanced malignancies, suggesting potential for success in this trial.

Eligibility criteria

Inclusion Criteria:

1. Histologically or cytologically documented advanced malignant tumors that is refractory/relapsed to standard therapies;
2. Adequate organ function;
3. ECOG Performance Status score of 0 or 1;
4. Must have at least one measurable lesion according to RECIST Version1.1;
5. Toxicity caused by prior anti-tumor therapy recovered to Grade 0 to 1 (CTCAE 5.0);
6. Must have an effective contraception during the study, starting with the Screening Visit through 7 months after the last dose of study intervention.

Exclusion Criteria:

1. Has active central nervous system metastatic lesions;
2. Has Active autoimmune disease requiring systemic therapy within the past 2 years;
3. Has Grade 2 and above peripheral neuropathy;
4. Has an active infection requiring systemic therapy;
5. Has a history of any of the following cardiovascular conditions within 6 months of dosing: myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, coronary artery bypass graft, pulmonary embolism, etc; has New York Heart Association (NYHA) Class II and above congestive heart failure; LVEF\<50%;
6. Has a history of hypertensive crisis or hypertensive encephalopathy; Uncontrolled hypertension though standard treatment within 14 days before the first dose (systolic blood pressure≥160 mmHg and/or diastolic blood pressure≥100mmHg);
7. Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections;
8. Has a history of potent CYP3A4 inhibitor with 2 weeks;
9. Has received systemic anticancer therapy, radiotherapy, or surgery within 4 weeks before the start of study treatment;
10. Have received previous treatment targeted LILRB4 or MMAE experiencing serious adverse events;
11. Have received previous immunotherapy experiencing serious adverse events that leading to permanent discontinuation;
12. Have received systemic corticosteroids (equivalent dose \> 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose;
13. Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAB) and or any components of the study intervention;
14. Any live vaccine within 28 days prior to the first dose;
15. Has a history of interstitial lung disease or active pneumonia or tracheal fistula; uncontrolled pleural, abdominal and pericardial effusion;
16. Has a history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 year.

Where this trial is running

Chongqing, Chongqing and 5 other locations

• Chongqing University Cancer Hospital — Chongqing, Chongqing, China (Recruiting)
• Henan Cancer Hospital — Zhengzhou, Henan, China (Recruiting)
• Hunan Cancer Hospital — Changsha, Hunan, China (Recruiting)
• Shanghai first maternity and infant hospital — Shanghai, Shanghai, China (Recruiting)
• Shanxi Provincial Cancer Hospital — Taiyuan, Shanxi, China (Recruiting)
• Zhejiang Cancer Hospital — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Dafei Ding

Conditions Advanced Malignant Tumors