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QLC5508 in Advanced Solid Tumors:: C-QTc, Pharmacokinetics (PK) Comparisons and Drug-drug Interaction

NCT07620041 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2026-06-02

No results posted yet for this study

Summary

A clinical trial of QLC5508 for advanced solid tumors

The goal of this clinical trial is to learn if QLC5508 can be given safely to adults with advanced solid tumors. It will also learn how two different formulations of QLC5508 compare in the body, and whether other drugs affect QLC5508. The main questions it aims to answer are:

Does a single injection of QLC5508 change the heart's electrical activity (QTc interval)?

How do the test formulation and the reference formulation of QLC5508 compare in the body (pharmacokinetics)?

Do other drugs (itraconazole, darolutamide, or rifampicin) change how the body processes QLC5508?

Investigators will compare the test formulation to the reference formulation, and will also give QLC5508 together with itraconazole, darolutamide, or rifampicin to look for drug-drug interactions.

Participants will:

Receive QLC5508 by injection into a vein;

Join one of three groups: two groups will receive both formulations of QLC5508 at different times (crossover) and also take rifampicin or itraconazole; the third group will take darolutamide with QLC5508;

Have heart monitoring (Holter) during the first dose;

Undergo regular blood tests, safety checks, and immunogenicity testing (to see if the body develops antibodies against QLC5508).

Conditions

  • Refractory or Relapsed Solid Tumors

Interventions

DRUG

QLC5508 (Investigational Product / Formulation T)

Single intravenous (IV) infusion of QLC5508 for pharmacokinetic (PK) and C-QTc assessment in patients with advanced solid tumors.

DRUG

QLC5508 (Reference Product / Formulation R)

Single IV infusion of QLC5508 for comparative PK evaluation against the investigational formulation.

DRUG

Itraconazole

Multiple oral doses of itraconazole capsules to evaluate the drug-drug interaction (DDI) potential via CYP3A4 inhibition.

DRUG

Darolutamide

Multiple oral doses of darolutamide tablets to evaluate the drug-drug interaction (DDI) potential.

DRUG

Rifampicin

Single oral dose of rifampicin capsules to evaluate the DDI potential.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-05
Primary Completion
2026-12-05
Completion
2027-02-05

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07620041 on ClinicalTrials.gov