A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors

NCT07256782 | Recruiting Phase 1

• 1 other identifier: QLC5508-201
• Study Type: interventional
• Target: 444
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• Maximum tolerated dose (MTD) for combination-treatments (Phase Ib)

  To determine the MTD for further evaluation of QLC5508 with other anti-cancer agents in participants with advanced solid tumors

  Up to day 21 (Q3W combination) or day 28 (Q2W combination) from the first dose

• Recommended Phase II Dose (RP2D) for combination-treatments (Phase Ib)

  To determine the RP2D for further evaluation of QLC5508 with other anti-tumor agents in participants with advanced solid tumors

  Up to day 21 (Q3W combination) or day 28 (Q2W combination) from the first dose

• Objective response rate (ORR) determined by investigators (Phase II)

  ORR is defined as proportion of participants with best overall response of complete response (CR) and partial response (PR) \[Confirmed CR/PR assessment require at least one repeat (4-6 weeks)\] evaluated by investigator according to RECIST v1.1

  Approximately 12 months

Secondary Outcomes (13)

• ORR determined by investigators (Phase Ib)

  Approximately 12 months

• Disease control rate (DCR) determined by investigators (Phase Ib and II)

  Approximately 12 months

• Duration of response (DOR) determined by investigators (Phase Ib and II)

  Approximately 12 months

• Progression-free survival (PFS) determined by investigators (Phase Ib and II)

  Approximately 12 months

• Overall survival (OS) (Phase Ib and II)

  Approximately 24 months

Study Arms (6)

QLC5508 and QL1706

EXPERIMENTAL

Drug: QLC5508; Drug: QL1706

QLC5508, QL1706 and Cisplatin/ Carboplatin

EXPERIMENTAL

Drug: QLC5508; Drug: QL1706; Drug: Cisplatin/ Carboplatin

QLC5508 and QL2107

EXPERIMENTAL

Drug: QLC5508; Drug: QL2107

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

EXPERIMENTAL

Drug: QLC5508; Drug: QL2107; Drug: 5-fluorouracil (5-FU)

QLC5508, QL2107 and Paclitaxel

EXPERIMENTAL

Drug: QLC5508; Drug: QL2107; Drug: Paclitaxel

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

EXPERIMENTAL

Drug: QLC5508; Drug: 5-fluorouracil (5-FU); Drug: Oxaliplatin

Interventions

QLC5508 DRUG

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

Also known as: MHB088C

QLC5508 and QL1706; QLC5508 and QL2107; QLC5508, Oxaliplatin, 5-fluorouracil (5-FU) and leucovorin; QLC5508, QL1706 and Cisplatin/ Carboplatin; QLC5508, QL2107 and 5-fluorouracil (5-FU); QLC5508, QL2107 and Paclitaxel

QL1706 DRUG

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

Also known as: Iparomlimab and Tuvonralimab，PSB205

QLC5508 and QL1706; QLC5508, QL1706 and Cisplatin/ Carboplatin

Cisplatin/ Carboplatin DRUG

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

QLC5508, QL1706 and Cisplatin/ Carboplatin

QL2107 DRUG

200 mg, Q3W,administered as an IV infusion

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

Paclitaxel DRUG

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

QLC5508, QL2107 and Paclitaxel

5-fluorouracil (5-FU) 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, Oxaliplatin, 5-fluorouracil (5-FU) and leucovorin; QLC5508, QL2107 and 5-fluorouracil (5-FU)

Oxaliplatin DRUG

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

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Received or undergoing any of the following treatment:
• Previous or current treatment with B7-H3 targeted therapy
• Previous or current treatment with topoisomerase I inhibitors
• 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
• 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

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Shanghai East Hospital

Shanghai, China

RECRUITING

MeSH Terms

Interventions

Cisplatin; Carboplatin; Paclitaxel; Fluorouracil; Oxaliplatin

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Coordination Complexes; Organic Chemicals; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Qianyun Liu, Master

CONTACT

+8653155821177; qianyun.liu@qilu-pharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 1, 2025
• Study Start: October 24, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 1, 2025

Record last verified: 2025-09

Locations

CN (1)