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RecruitingNCT05830045Updated Jun 27, 2024

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

A Phase 1 interventional study of QLP2117 in Advanced Solid Tumors, sponsored by Qilu Pharmaceutical Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-06-27.

Sponsored by Qilu Pharmaceutical Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2025, 1 year 5 months ago, but the record still lists the study as recruiting.
  • Started May 2023; still recruiting 3 years 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Advanced Solid Tumors

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 180 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Qilu Pharmaceutical Co., Ltd. is the lead sponsor of 193 studies on the registry; 119 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Ia: QLP2117 Dose escalation and PK expansion

    Drug: QLP2117

  • Experimental
    Ib:QLP2117 Dose expansion

    Drug: QLP2117

Interventions

  • DrugQLP2117

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  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

07

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen University Cancer Center
    Guangzhou, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 27, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05830045
Lead sponsor
Qilu Pharmaceutical Co., Ltd.
Responsible party
Sponsor
First posted
Apr 26, 2023
Start date
May 19, 2023
Primary completion
Apr 30, 2025 (estimated)
Completion
Dec 31, 2025 (estimated)
Last update
Jun 27, 2024

Study contacts

Zhang Meijiang, PhD
Contact
meijiang.zhang@qilu-pharma.com
8615210162105
Xu Ruihua, PhD
principal investigator · Sun Yat-sen University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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