A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: QL2107; Drug: QLP2117

Study type: Interventional

Funder types: Industry

Identifiers

NCT06911827

QLP2117-201

Details and patient eligibility

About

The goal of this clinical trial is to evaluate the safety and efficacy of QLP2117 in combination with QL2107 in Advanced Solid Tumor Patients.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
• At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Iba dose escalation only requires at least one assessable lesion)
• Eastern Cooperative Oncology Group Performance Status of 0 or 1
• Agree to provide archived tumor tissue samples of primary or metastatic lesions.
• Have adequate organ function as described in the protocol.

Exclusion criteria

• Women who are pregnant or breastfeeding
• HBsAg/HBcAb positive and HBV-DNA>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
• Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
• Has an active autoimmune disease that has required systemic treatment in past 2 years.
• Has an active infection requiring systemic therapy
• Has received a live vaccine wihtin 30 days of planned start of study treatment
• Known history of, or any evidence of interstitial lung disease

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Ib/II

Experimental group

Description:

* Experimental: Ib： QLP2117 in combination with QL2107 Dose escalation and PK expansion * Experimental: II： QLP2117 in combination with QL2107 Dose expansion

Treatment:

Drug: QLP2117

Drug: QL2107