SG2918 For Advanced Malignant Tumors

NCT06167486 | Active Not Recruiting Phase 1

• 1 other identifier: CSG-2918-101
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 6

Brief Summary

This is a Phase I, open-label, dose escalation and dose expansion study to Evaluate the Safety, Tolerability and Preliminary Efficacy of SG2918 in subjects with Advanced Malignant Tumors who are refractory or resistant to standard therapy, or without available standard or curative therapy.

Conditions

Advanced Malignant Tumors

Outcome Measures

Primary Outcomes (2)

• Incidence of Treatment-Emergent Adverse Events

  Number and percentage of AEs which is calculated by worst CTCAE grade by CTCAE 5.0

  From the time of first dose until 30 days after last dose of SG2918

• Number of Participants Who Experience a Dose-Limiting Toxicity (DLT)

  DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria and assessed as related to study drug, and unrelated to disease, disease progression, intercurrent illness or concomitant medications that occurs within the first cycle (three weeks) of treatment.

  Cycle 1 (up to 21 days)

Secondary Outcomes (8)

• Pharmacokinetics(PK): Cmax

  From the time of first dose until 30 days after last dose of SG2918

• Pharmacokinetics (PK): AUC

  From the time of first dose until 30 days after last dose of SG2918

• Pharmacokinetics (PK): T1/2

  From the time of first dose until 30 days after last dose of SG2918

• Pharmacokinetics (PK): CL

  From the time of first dose until 30 days after last dose of SG2918

• Pharmacodynamic(PD): cellular biomarkers

  From the time of first dose until 30 days after last dose of SG2918

Study Arms (1)

SG2918

EXPERIMENTAL

SG2918 monotherapy

Drug: SG2918

Interventions

SG2918 DRUG

The SG2918 will be administrated by intravenous infusion every 3 weeks

SG2918

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Has active central nervous system metastatic lesions;
• Has Active autoimmune disease requiring systemic therapy within the past 2 years;
• Has Grade 2 and above peripheral neuropathy;
• Has an active infection requiring systemic therapy;
• 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%;
• 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);
• Has known human immunodeficiency virus (HIV) and/or hepatitis B or C infections;
• Has a history of potent CYP3A4 inhibitor with 2 weeks;
• Has received systemic anticancer therapy, radiotherapy, or surgery within 4 weeks before the start of study treatment;
• Have received previous treatment targeted LILRB4 or MMAE experiencing serious adverse events;
• Have received previous immunotherapy experiencing serious adverse events that leading to permanent discontinuation;
• Have received systemic corticosteroids (equivalent dose \> 10 mg/day of prednisone) or other immunosuppressive drugs within 14 days prior to the first dose;
• Has had a severe hypersensitivity reaction to treatment with a monoclonal antibody (mAB) and or any components of the study intervention;
• Any live vaccine within 28 days prior to the first dose;
• Has a history of interstitial lung disease or active pneumonia or tracheal fistula; uncontrolled pleural, abdominal and pericardial effusion;

Sponsors & Collaborators

• Hangzhou Sumgen Biotech Co., Ltd.: lead

Study Sites (6)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

Location

Hunan Cancer Hospital

Changsha, Hunan, 410031, China

Location

Shanghai first maternity and infant hospital

Shanghai, Shanghai Municipality, 200126, China

Location

Shanxi Provincial Cancer Hospital

Taiyuan, Shanxi, 30013, China

Location

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310005, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 12, 2023
• Study Start: December 26, 2023
• Primary Completion: November 11, 2025
• Study Completion (Estimated): December 28, 2026
• Last Updated: March 9, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)