Study of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors

NCT07272590 | Not Yet Recruiting Phase 1

• 1 other identifier: QLC5513-201
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this Phase Ib/II interventional study is to evaluate the safety, tolerability, pharmacokinetics and efficacy of QLC5513 combined with QL1706± platinum in the treatment of patients with advanced or metastatic malignant solid tumors. This study is divided into two phases: Phase Ib is the combined dose escalation phase, where dose escalation of QLC5513 combined with QL1706± platinum is conducted and RP2D is explored; In the Phase II tumor type expansion study stage, the primary objective is to evaluate the objective response rate (ORR) of QLC5513 combined with QL1706± platinum-based treatment in patients with advanced or metastatic malignant solid tumors.

Conditions

Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (3)

• The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLC5513 combined with QL1706± platinum in patients with advanced solid tumors.

  up to 12 months

• Number of participants who experience one or more adverse events(AEs).

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  up to 48 months

• Objective Response Rate

  ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by investigator.

  up to 36 months

Secondary Outcomes (3)

• DOR

  up to 48 months

• PFS

  up to 48 months

• OS

  up to 60 months

Study Arms (2)

Arm A: QLC5513+QL1706

EXPERIMENTAL

Drug: QLC5513 IV infusion; Biological: QL1706, IV infusion

Arm B: QLC5513+QL1706+ platinum

EXPERIMENTAL

Drug: QLC5513 IV infusion; Biological: QL1706, IV infusion; Drug: platinum, IV infusion

Interventions

QL1706, IV infusion BIOLOGICAL

QL1706 5mg/kg intravenously on Day 1 of 21-day.

Arm A: QLC5513+QL1706; Arm B: QLC5513+QL1706+ platinum

platinum, IV infusion DRUG

Cisplatin: 75 mg/m ² or carboplatin：AUC=5 mg/mL/min on Day 1 of 21-day.

Arm B: QLC5513+QL1706+ platinum

QLC5513 IV infusion DRUG

Participants will receive QLC5513 16 mg/kg intravenously on Days1, Day 8 and Day 15 of 28-day cycles.

Arm A: QLC5513+QL1706; Arm B: QLC5513+QL1706+ platinum

Eligibility Criteria

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

You may qualify if:

• Has an eastern cooperative oncology group (ECOG) performance status of 0 to 1.
• Has adequate organ function.
• The expected survival period is ≥3 months.
• Based on the pathological report of the most recent biopsy or other pathological specimens, advanced or metastatic solid tumors confirmed by histology or cytology are not suitable for radical treatments such as surgery and radiotherapy.
• According to the RECIST v1.1 evaluation criteria, the participants had at least one radiologically measurable lesion.

You may not qualify if:

• Prior treatment with TROP2-targeting agents, ADCs with topoisomerase 1 inhibitor (TOP1i) payloads, or other TOP1i drugs.
• There was symptomatic central nervous system (CNS) metastasis, leptomeningeal metastasis or spinal cord compression caused by metastasis before the first use of the investigational product.
• Active, uncontrolled bacterial, fungal or viral infections.
• Radiotherapy with more than 25% of the bone marrow exposed within 4 weeks prior to the first use of the investigational drug; Local radiotherapy (excluding brain radiotherapy) was performed within two weeks before the first use of the investigational drug.
• Subjects with a history of a second malignant tumor other than the target indication within 5 years prior to signing the informed consent (excluding cured basal cell skin cancer, superficial bladder cancer, carcinoma in situ of the breast, papillary thyroid carcinoma, etc.).
• Prior to the first dose of the investigational product, all reversible toxicities from prior anti-tumor therapy (excluding alopecia and pigmentation) have not recovered to ≤ Grade 1 (as assessed by CTCAE v5.0), with the exception that peripheral neuropathy must have not recovered to ≤ Grade 2. History of irAEs from prior immune checkpoint inhibitor treatment that required permanent discontinuation of the immune checkpoint inhibitor.
• Active autoimmune disease that has required systemic treatment in the past 2 years.

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

MeSH Terms

Interventions

Infusions, Intravenous; Platinum

Intervention Hierarchy (Ancestors)

Administration, Intravenous; Drug Administration Routes; Drug Therapy; Therapeutics; Infusions, Parenteral; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Central Study Contacts

Zefei Jiang, Professor

CONTACT

86-010-66947175; jzf_cscobc@csco.org.cn

Study Design

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

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: December 9, 2025
• Study Start: December 30, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2031
• Last Updated: December 9, 2025

Record last verified: 2025-11