Solid Tumor CancerPhase 1NCT07467629
QLS5212 for Participants With Advanced Solid Tumors
A Phase 1 study testing QLS5212 in people with Solid Tumor Cancer, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor Cancer
- What is being tested?
- QLS5212
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2026to 5 Apr 2028
- Phase
- Phase 1
- 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
- Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.
- Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
- Life expectancy ≥ 3 months.
Show all 16Show fewer
- Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and/or MRI.
- 7. Acceptable laboratory parameters:
- Absolute neutrophil count ≥ 1,500/μL.
- Platelet count ≥ 100 × 1000/μL
- Hemoglobin ≥ 9.0 g/dL.
- Albumin ≥ 3 g/dL.
- ALT/AST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.）
- Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease.
- a calculated or measured creatinine clearance ≥60 mL/minute.
- Identification of an archival tumor sample (i.e., tissue block [formalin-fixed paraffin-embedded] or a series of approximately 10-15 slides).
Who cannot join
- History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;
- Untreated or active brain metastases, including leptomeningeal carcinomatosis;
- Prior systemic anti-cancer therapy within specified windows;
- Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;
- Clinically significant cardiovascular disease;
- Uncontrolled systemic infection or active tuberculosis;
- Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years;
- Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanxi Provincial Cancer Hospital (China Medical Sciences Academy Cancer Hospital Shanxi Hospital)
Taiyuan
Jie Wang, Doctor, 0351-4881611, zlhuxi@163.com
About this study
Official title: A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5212 Monotherapy in Participants With Advanced Solid Tumors
This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.
- Conditions
- Solid Tumor Cancer
- Being tested
- QLS5212
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS5212Drug
An anti-trophoblast glycoprotein antibody-drug conjugate
| Study group | Role | What they receive |
|---|---|---|
| QLS5212 Dose Escalation | Experimental | Not described Receives: Drug: QLS5212 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD)
Measured: From First Patient Dosed to end of Escalation (up to 14 months).
Dose-limiting Toxicity (DLT)
Measured: From enrollment to 21 days of treatment.
Recommended Phase 2 dose (RP2D)
Measured: From First Patient Dosed to end of Escalation (up to 14 months).
Incidence of Treatment-Emergent Adverse Events
Measured: From enrollment of the first participant to 30 days after last dose of treatment or End of Treatment [EOT] visit (whichever is later).
Secondary outcomes (3)
Maximum Plasma Concentration of QLS5212
Measured: From Day 1 of dosing through 7 days after last dose.
Area Under the Curve (AUC) of QLS5212
Measured: From Day 1 of dosing to 7 days after last dose.
Circulating anti-drug antibodies (ADA) of QLS5212
Measured: From Day 1 of dosing to 7 days after last dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start11 May 2026
- Primary completion5 Nov 2027 (estimated)
- Study completion5 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467629
- Sponsor's protocol ID
- QLS5212-101
- Status last verified
- May 2026
- First submitted
- 8 Mar 2026
- Last updated
- 19 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLS5212 Monotherapy in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07467629
- Acronym / sponsor ID
- QLS5212-101
- Conditions
- Solid Tumor Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 5 Nov 2027 (estimated)
- Study completion
- 5 Apr 2028 (estimated)
- First posted
- 12 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS5212 Dose Escalation | Experimental | Drug: QLS5212 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease.
- Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens.
- Age ≥ 18 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors.
Key exclusion criteria (8 listed)
- History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose;
- Untreated or active brain metastases, including leptomeningeal carcinomatosis;
- Prior systemic anti-cancer therapy within specified windows;
- Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy;
- Clinically significant cardiovascular disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QLS5212An anti-trophoblast glycoprotein antibody-drug conjugate | Drug | QLS5212 Dose Escalation |
Primary outcome
Maximum tolerated dose (MTD)
Time frame: From First Patient Dosed to end of Escalation (up to 14 months).
Dose-limiting Toxicity (DLT)
Time frame: From enrollment to 21 days of treatment.
Recommended Phase 2 dose (RP2D)
Time frame: From First Patient Dosed to end of Escalation (up to 14 months).
Incidence of Treatment-Emergent Adverse Events
Time frame: From enrollment of the first participant to 30 days after last dose of treatment or End of Treatment [EOT] visit (whichever is later).
3 secondary outcomes
Maximum Plasma Concentration of QLS5212
Time frame: From Day 1 of dosing through 7 days after last dose.
Area Under the Curve (AUC) of QLS5212
Time frame: From Day 1 of dosing to 7 days after last dose.
Circulating anti-drug antibodies (ADA) of QLS5212
Time frame: From Day 1 of dosing to 7 days after last dose.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
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Solid Tumors
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing QLS5212 in people with Solid Tumor Cancer, 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 16 inclusion and 8 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 19 May 2026. 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 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.
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 Jie Wang, Doctor (0351-4881611, zlhuxi@163.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) (time frame: From First Patient Dosed to end of Escalation (up to 14 months).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 May 2026.