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

Phase 1

Not yet recruiting

• Conditions: Advanced Solid Tumor
• Interventions: Drug: QLP2117; Drug: QL2107

• Registration Number: NCT06911827
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-03-28
• Study Start: 2025-04
• Study First Posted: 2025-04-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ib/II	QLP2117	* Experimental: Ib： QLP2117 in combination with QL2107 Dose escalation and PK expansion * Experimental: II： QLP2117 in combination with QL2107 Dose expansion
Ib/II	QL2107	* Experimental: Ib： QLP2117 in combination with QL2107 Dose escalation and PK expansion * Experimental: II： QLP2117 in combination with QL2107 Dose expansion

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity(DLT)	21days
Percentage of Participants Experiencing Adverse Events (AEs) According to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0	up to 96 weeks
Objective Response Rate for phase II	up to 96 weeks