A Phase I Study of QL1604 for Advanced Solid Tumors

• Status: Active, not recruiting
• Trial end date: 2023-12-15
• Target enrollment: 0
• Participant gender: All

Summary

In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Criteria

Key Inclusion Criteria:

• 18-75 years;

• At least one measureable lesion as defined per RECIST Version (v) 1.1

• Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis

• Adequate important organ function

Key Exclusion Criteria:

• Active autoimmune disease orautoimmune disease history

• Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of > 10 mg/day or equivalent hormone) for more than 2 weeks)

• Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients

• Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks)

• Active hepaititis B or C infection

• Both HBsAg and anti-HCV Ab positive