A Phase I Study of QLP2117 in Subjects With Advanced Solid Tumors

Phase 1

Recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Drug: QLP2117

• Registration Number: NCT05830045
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief Summary

This is the first in human study of QLP2117. To evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in patients with advanced solid tumors.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-04
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-04-26
• Study Start: 2023-05-19
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2025-04-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

1. 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.
2. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion)
3. Eastern Cooperative Oncology Group Performance Status of 0 or 1
4. Agree to provide archived tumor tissue samples of primary or metastatic lesions.
5. Have adequate organ function as described in the protocol.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Ia： QLP2117 Dose escalation and PK expansion	QLP2117	-
Ib：QLP2117 Dose expansion	QLP2117	-

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity(DLT)	21days
Objective Response Rate for phase 1b	up to 96 weeks
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

Trial Locations

Locations (1)

Sun Yat-sen University Cancer Center; 🇨🇳 Guangzhou, China