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Metastatic Solid TumorsPhase 1/2NCT07272590

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

A Phase 1/2 study testing QLC5513 IV infusion, QL1706, IV infusion and platinum, IV infusion in people with Metastatic Solid Tumors, run by Qilu Pharmaceutical Co., Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Solid Tumors
What is being tested?
QLC5513 IV infusion, QL1706, IV infusion and platinum, IV infusion
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
290 participants
Where
No sites listed yet
Study dates
30 Dec 2025to Aug 2031
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Zefei Jiang, Professor contact

86-010-66947175

jzf_cscobc@csco.org.cn

About this study

Official title: An Open, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid Tumors

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.

Being tested
QLC5513 IV infusion, QL1706, IV infusion, platinum, IV infusion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • QLC5513 IV infusionDrug

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

  • QL1706, IV infusionBiological

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

  • platinum, IV infusionDrug

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

Study groups in NCT07272590
Study groupRoleWhat they receive
Arm A: QLC5513+QL1706ExperimentalNot described
Receives: Drug: QLC5513 IV infusion; Biological: QL1706, IV infusion
Arm B: QLC5513+QL1706+ platinumExperimentalNot described
Receives: Drug: QLC5513 IV infusion; Biological: QL1706, IV infusion; Drug: platinum, IV infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: up to 12 months

  2. 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.

    Measured: up to 48 months

  3. 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.

    Measured: up to 36 months

Secondary outcomes (3)

  1. DOR

    For participants who demonstrate a confirmed 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), DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by investigator.

    Measured: up to 48 months

  2. PFS

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by Response Criteria in Solid Tumors Version1.1 (RECIST 1.1). PD is defined as ≥20%increase in the sum of diameters of target lesions. In addition to the relative increase of20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearanceof one or more new lesions is alsoconsidered PD. PFS as assessed by investigator.

    Measured: up to 48 months

  3. OS

    OS is defined as the time from randomization to death due to any cause.

    Measured: up to 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start30 Dec 2025 (estimated)
  3. Primary completionJun 2027 (estimated)
  4. Study completionAug 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
290 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07272590
Sponsor's protocol ID
QLC5513-201
Status last verified
Nov 2025
First submitted
26 Nov 2025
Last updated
9 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing QLC5513 IV infusion, QL1706, IV infusion and platinum, IV infusion in people with Metastatic Solid Tumors, run by Qilu Pharmaceutical Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Zefei Jiang, Professor (86-010-66947175, jzf_cscobc@csco.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum tolerated dose (MTD)/maximum administration dose (MAD) and RP2D of QLC5513 combined with QL1706± platinum in patients with advanced solid tumors. (time frame: up to 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07272590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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