A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors

NCT ID: NCT07256782

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 444 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-24
• Study Completion Date: 2028-05-31

Brief 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.

Detailed Description

This is a phase Ib/II, open-label, multi-center, dose-escalation and expansion in Chinese subjects with advanced solid tumors. This study is in design allowing assessment of safety, tolerability, pharmacokinetics and anti-tumor activity of QLC5508 in combination with other anti-cancer agents.

The target population of dose escalation part is patients have progressed on or intolerant to available standard therapies, and the dose expansion part will enroll patients who have not received prior treatment for advanced/metastatic disease.

Conditions

Advanced Solid Tumor

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QLC5508 and QL1706

Group Type: EXPERIMENTAL

QLC5508

Intervention Type: DRUG

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

QL1706

Intervention Type: DRUG

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

QLC5508, QL1706 and Cisplatin/ Carboplatin

Group Type: EXPERIMENTAL

QLC5508

Intervention Type: DRUG

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

QL1706

Intervention Type: DRUG

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

Cisplatin/ Carboplatin

Intervention Type: DRUG

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

QLC5508 and QL2107

Group Type: EXPERIMENTAL

QLC5508

Intervention Type: DRUG

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

QL2107

Intervention Type: DRUG

200 mg, Q3W,administered as an IV infusion

QLC5508, QL2107 and 5-fluorouracil (5-FU)

Group Type: EXPERIMENTAL

QLC5508

Intervention Type: DRUG

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

QL2107

Intervention Type: DRUG

200 mg, Q3W,administered as an IV infusion

5-fluorouracil (5-FU)

Intervention Type: DRUG

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

QLC5508, QL2107 and Paclitaxel

Group Type: EXPERIMENTAL

QLC5508

Intervention Type: DRUG

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

QL2107

Intervention Type: DRUG

200 mg, Q3W,administered as an IV infusion

Paclitaxel

Intervention Type: DRUG

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

QLC5508, Oxaliplatin, 5-fluorouracil (5-FU) and leucovorin

Group Type: EXPERIMENTAL

QLC5508

Intervention Type: DRUG

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

5-fluorouracil (5-FU)

Intervention Type: DRUG

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

Oxaliplatin

Intervention Type: DRUG

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

Interventions

QLC5508

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

Intervention Type: DRUG

QL1706

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

Intervention Type: DRUG

Cisplatin/ Carboplatin

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

Intervention Type: DRUG

QL2107

200 mg, Q3W,administered as an IV infusion

Intervention Type: DRUG

Paclitaxel

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

Intervention Type: 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

Intervention Type: DRUG

Oxaliplatin

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

Intervention Type: DRUG

Other Intervention Names

MHB088C; Iparomlimab and Tuvonralimab，PSB205

Eligibility Criteria

Inclusion Criteria

• At least 18 years of age at screening;
• Histologically or cytologically confirmed advanced solid tumors:

Dose escalation part will enroll participants who have progressed on or are intolerant to available standard therapies.

Dose expansion part will enroll participants who have not received prior treatment for advanced/metastatic diseases.

• At least one measurable target lesion according to RECIST v1.1
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
• Life expectancy ≥12 weeks
• Female or male participants should be willing to use appropriate contraceptive measures throughout the study;
• Female participants should have a negative blood pregnancy test within 7 days prior to the first dose or have evidence of non-childbearing potential;
• A signed written Informed Consent Form

Exclusion Criteria

• . Received or undergoing any of the following treatment:

1. Previous or current treatment with B7-H3 targeted therapy

2. Previous or current treatment with topoisomerase I inhibitors

3. Previous treatment with cytotoxic chemotherapy, investigational agents, traditional Chinese medicine with an anti-tumor indication and antitumor drugs within 14 days prior to the first dose

4. Previous treatment with macromolecular antitumor drugs within 28 days prior to the first dose

f. Radiotherapy with a limited field of radiation within 2 weeks prior to the first dose; or more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first dose e. Pleural effusion or ascites requiring clinical intervention; or presence of pericardial effusion f. Major surgery within 4 weeks prior to the first dose g. Brain metastases; leptomeningeal or brainstem metastases; or spinal cord compression

• Unresolved AEs ≥ Grade 2 (CTCAE v5.0) from prior therapy except for alopecia and residual neuropathy
• Previous or concurrent primary malignancies
• Inadequate bone marrow reserve or organ dysfunction
• Evidence of cardiovascular risk
• Evidence of current severe or uncontrolled systemic diseases
• Severe infection within 4 weeks prior to the first dose; or uncontrolled active infection at screening
• Known or suspected interstitial lung disease; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity
• High risk of gastrointestinal or abdominal bleeding 10. Gastrointestinal diseases of clinical significance within 3 months prior to the first dose
• History of severe neuropathy or mental disorders
• History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to QLC5508 or any of the components of QLC5508
• Unlikely to comply with study procedures and requirements in the opinion of the investigator
• Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai East Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Qianyun Liu, Master

Role: CONTACT

qianyun.liu@qilu-pharma.com

+8653155821177

Facility Contacts

caicun Zhou, M.D

Role: primary

Other Identifiers

QLC5508-201

Identifier Type: -

Identifier Source: org_study_id