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

April 24, 2023 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

180

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ia： QLP2117 Dose escalation and PK expansion
Drug: QLP2117
Specified dose on specified days
Experimental: Ib：QLP2117 Dose expansion
Drug: QLP2117
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity(DLT)
Time Frame: 21days
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
Time Frame: up to 96 weeks
up to 96 weeks
Objective Response Rate for phase 1b
Time Frame: up to 96 weeks
up to 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Xu Ruihua, PhD, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 20, 2023

Primary Completion (Anticipated)

April 30, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

April 24, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Actual)

April 26, 2023

Last Update Submitted That Met QC Criteria

April 24, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QLP2117-101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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