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Advanced Solid TumorPhase 1/2NCT07256782

A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors

A Phase 1/2 study testing QLC5508, QL1706 and Cisplatin/ Carboplatin in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumor
What is being tested?
QLC5508, QL1706 and Cisplatin/ Carboplatin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
444 participants
Where
1 siteChina
Study dates
24 Oct 2025to May 2028
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

  • 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
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  • 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

Who cannot join

  • . 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
  • 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
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  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qianyun Liu, Master contact

+8653155821177

qianyun.liu@qilu-pharma.com

China1 site, 1 recruiting

  • Shanghai East Hospital

    Shanghai

    caicun Zhou, M.D

    Recruiting

Other trials in China

About this study

Official title: A Phase Ib/II, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of QLC5508 in Combination With Other Anti-tumor Agents in Patients With Advanced Solid Tumors

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.

Read the 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.

Being tested
QLC5508, QL1706, Cisplatin/ Carboplatin, QL2107, Paclitaxel

What participants receive

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

  • QLC5508Drug

    Also called MHB088C

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

  • QL1706Drug

    Also called Iparomlimab and Tuvonralimab，PSB205

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

  • Cisplatin/ CarboplatinDrug

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

  • QL2107Drug

    200 mg, Q3W,administered as an IV infusion

  • PaclitaxelDrug

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

  • 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

  • OxaliplatinDrug

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

Study groups in NCT07256782
Study groupRoleWhat they receive
QLC5508 and QL1706ExperimentalNot described
Receives: Drug: QLC5508; Drug: QL1706
QLC5508, QL1706 and Cisplatin/ CarboplatinExperimentalNot described
Receives: Drug: QLC5508; Drug: QL1706; Drug: Cisplatin/ Carboplatin
QLC5508 and QL2107ExperimentalNot described
Receives: Drug: QLC5508; Drug: QL2107
QLC5508, QL2107 and 5-fluorouracil (5-FU)ExperimentalNot described
Receives: Drug: QLC5508; Drug: QL2107; Drug: 5-fluorouracil (5-FU)
QLC5508, QL2107 and PaclitaxelExperimentalNot described
Receives: Drug: QLC5508; Drug: QL2107; Drug: Paclitaxel
QLC5508, Oxaliplatin, 5-fluorouracil (5-FU) and leucovorinExperimentalNot described
Receives: Drug: QLC5508; Drug: 5-fluorouracil (5-FU); Drug: Oxaliplatin

What is being measured

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

  1. 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

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

  2. 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

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

  3. 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

    Measured: Approximately 12 months

Secondary outcomes (13)

  1. ORR determined by investigators (Phase Ib)

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

    Measured: Approximately 12 months

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

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

    Measured: Approximately 12 months

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

    DOR is defined as the period from the first occurrence of CR or PR to PD or death from any cause [Confirmed CR/PR assessment require at least one repeat (4-6 weeks)]

    Measured: Approximately 12 months

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

    PFS is defined as the time from the first dose to PD or death from any cause.

    Measured: Approximately 12 months

  5. Overall survival (OS) (Phase Ib and II)

    OS is defined as the time from the first dose to death from any cause

    Measured: Approximately 24 months

  6. Incidence and severity of adverse events (AEs) (Phase II)

    Any untoward medical occurrence in a clinical study participant, which may manifest as symptoms, signs, diseases, or laboratory abnormalities, are assessed by investigator according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), v5.0

    Measured: From the first dose through 90 days post end of treatment

  7. Observed maximum plasma concentration (Cmax) of QLC5508 in advanced solid tumor (Phase Ib and II)

    Cmax will be obtained after administration of the first dose of QLC5508

    Measured: From pre-dose to study completion, approximately 24 months

  8. Time to reach maximum plasma concentration (Tmax) of QLC5508 (Phase Ib)

    Tmax will be obtained after administration of the first dose of QLC5508

    Measured: From pre-dose to study completion, approximately 24 months

  9. Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of QLC5508 (Phase Ib)

    Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule.

    Measured: From pre-dose to study completion, approximately 24 months]

  10. Observed maximum plasma concentration (Cmax) of QL1706 in advanced solid tumor (Phase Ib and II)

    Cmax will be obtained after administration of the first dose of QL1706

    Measured: From pre-dose to study completion, approximately 24 months

  11. Observed maximum plasma concentration (Cmax) of QL2107 in advanced solid tumor (Phase Ib and II)

    Cmax will be obtained after administration of the first dose of QL2107

    Measured: From pre-dose to study completion, approximately 24 months

  12. Percentage of participants with antibodies to QLC5508 in serum (Phase Ib and II)

    Serum samples were collected for the determination of anti-drug antibody (ADA) at designated time points.

    Measured: From pre-dose to study completion, approximately 24 months

  13. Percentage of participants with antibodies to QL1706 in serum (Phase Ib and II)

    Serum samples were collected for the determination of ADA at designated time points

    Measured: From pre-dose to study completion, approximately 24 months

Timeline

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

  1. First posted1 Dec 2025
  2. Study start24 Oct 2025
  3. Primary completionOct 2026 (estimated)
  4. Study completionMay 2028 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
444 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07256782
Sponsor's protocol ID
QLC5508-201
Status last verified
Sep 2025
First submitted
28 Sep 2025
Last updated
1 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 QLC5508, QL1706 and Cisplatin/ Carboplatin in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

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 10 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 Qianyun Liu, Master (+8653155821177, qianyun.liu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) for combination-treatments (Phase Ib) (time frame: Up to day 21 (Q3W combination) or day 28 (Q2W combination) from the first dose). 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 NCT07256782.

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 1 Dec 2025.

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