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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05830045
Recruitment Status : Not yet recruiting
First Posted : April 26, 2023
Last Update Posted : April 26, 2023
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: QLP2117 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients
Estimated Study Start Date : April 20, 2023
Estimated Primary Completion Date : April 30, 2025
Estimated Study Completion Date : December 31, 2025

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




Primary Outcome Measures :
  1. Dose-limiting toxicity(DLT) [ Time Frame: 21days ]
  2. 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 ]
  3. Objective Response Rate for phase 1b [ Time Frame: up to 96 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05830045


Contacts
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Contact: Zhang Meijiang, PhD 8615210162105 meijiang.zhang@qilu-pharma.com

Sponsors and Collaborators
Qilu Pharmaceutical Co., Ltd.
Investigators
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Principal Investigator: Xu Ruihua, PhD Sun Yat-sen University
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Responsible Party: Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT05830045    
Other Study ID Numbers: QLP2117-101
First Posted: April 26, 2023    Key Record Dates
Last Update Posted: April 26, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms