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

Sponsor
Qilu Pharmaceutical Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05830045
Collaborator
(none)
180
Enrollment
2
Arms
32.4
Anticipated Duration (Months)

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Apr 20, 2023
Anticipated Primary Completion Date :
Apr 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Dose-limiting toxicity(DLT) [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 [up to 96 weeks]

  3. Objective Response Rate for phase 1b [up to 96 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Qilu Pharmaceutical Co., Ltd.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Qilu Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT05830045
Other Study ID Numbers:
  • QLP2117-101
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Neoplasms

Study Results

No Results Posted as of Apr 26, 2023