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NCT Number: NCT06911827

A Study of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

The goal of this clinical trial is to evaluate the safety and efficacy of QLP2117 in combination with QL2107 in Advanced Solid Tumor Patients.

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Key information

Conditions

Advanced Solid Tumor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Iba dose escalation only requires at least one assessable lesion)
  • Eastern Cooperative Oncology Group Performance Status of 0 or 1
  • Agree to provide archived tumor tissue samples of primary or metastatic lesions.
  • Have adequate organ function as described in the protocol.

Exclusion criteria

  • Women who are pregnant or breastfeeding
  • HBsAg/HBcAb positive and HBV-DNA>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication
  • Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has an active infection requiring systemic therapy
  • Has received a live vaccine wihtin 30 days of planned start of study treatment
  • Known history of, or any evidence of interstitial lung disease

Treatment and study plan

QLP2117

Drug

Specified dose on specified days

QL2107

Drug

Specified dose on specified days

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 II

    Time frame: up to 96 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Ruihua Xu, PhD

CONTACT

[email protected]

+086-020-87343468

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Phase Ib/II Open-Label, Dose-Escalation and Dose-expansion Clinical Study to Evaluate the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Combination With QL2107 in Advanced Solid Tumor Patients

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 4, 2025
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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