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A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors

NCT07256782 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 444

Last updated 2025-12-01

No results posted yet for this study

Summary

QLC5508 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of QLC5508 in combination with other anti-cancer agents in patients with advanced solid tumor patients.

Conditions

  • Advanced Solid Tumor

Interventions

DRUG

QLC5508

2.4 mg/kg and 2.0 mg/kg, Q3W/Q2W,administered as an IV infusion

DRUG

QL1706

5 mg/kg ,Q3W,administered as an IV infusion

DRUG

Cisplatin/ Carboplatin

Cisplatin(75 mg/m2; Q3W) / Carboplatin（AUC 5 mg/mL/min; Q3W）,administered as an IV infusion

DRUG

QL2107

200 mg, Q3W,administered as an IV infusion

DRUG

Paclitaxel

175 mg/m2, Q3W,administered as an IV infusion

DRUG

5-fluorouracil (5-FU)

800 mg/m2,Q3W(arm:QLC5508, QL2107 and 5-FU),administered as an IV infusion;1200 mg/m2, Q2W(arm:QLC5508, Oxaliplatin, 5-FU,and leucovorin),administered as an IV infusion

DRUG

Oxaliplatin

30 mg/m2, Q2W,administered as an IV infusion

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
2025-10-24
Primary Completion
2026-10-31
Completion
2028-05-31

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 NCT07256782 on ClinicalTrials.gov