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

Advanced Solid Tumors Clinical Trial

Official title:

A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830045
• Other study ID #: QLP2117-101
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: April 20, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2023
• Source: Qilu Pharmaceutical Co., Ltd.
• Contact: Zhang Meijiang, PhD
• Phone: 8615210162105
• Email: meijiang.zhang[@]qilu-pharma.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: December 31, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Solid Tumors
• Neoplasms

Intervention

Drug:
• QLP2117
Specified dose on specified days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-limiting toxicity(DLT)		21days
Primary	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
Primary	Objective Response Rate for phase 1b		up to 96 weeks