A Phase I Study of QL1604 for Advanced Solid Tumors

Qilu Pharmaceutical

Status and phase: Active, not recruiting; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: QL1604

Study type: Interventional

Funder types: Industry

Identifiers

NCT05801094

QL1604-002

Details and patient eligibility

About

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

Enrollment: 71 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

QL1604

Experimental group

Treatment:

Drug: QL1604