Advanced Solid TumorPhase 1NCT05461287
Safety, Tolerability and Pharmacokinetics Study of QLS31904 in Patients With Advanced Solid Tumors
A Phase 1 study testing QLS31904 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is an open label, phase 1 clinical study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) of QLS31904 q2w/q3w intravenous use in patients with advanced solid tumors. 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?
- QLS31904
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2022to 25 May 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Understanding and voluntarily signing the informed consent form;
- Male or female, age≥18 years;
- Patients with histologically or cytologically confirmed advanced solid tumors including small cell lung cancer, small cell cancers in other organs or neuroendocrine carcinoma who have progression after on theor intolerance to standard of care, or have no effective standard therapeutic regimen;
- Tumours must be confirmed expression of DLL3.
- Presence of at least one measurable lesion meeting the requirements in RECIST v1.1 evaluation criteria;
- ECOG PS score: 0~1;
- Patients with life expectancy ≥3 months;
- Adequate organ function as defined in protocol. Futher inclusion criteria apply.
Who cannot join
- Having received the treatment targeting CD3 or DLL3 previously;
- Receiving any systematic antitumor therapy or other investigational product within 4 weeks prior to the first dose of QLS31904;
- Receiving radiotherapy within 2 weeks prior to the first dose of QLS31904;
- For the dose-escalation, participants who experienced severe immune-mediated AEs while on treatment with Immune checkpoint inhibitors (e.g., anti PD-L1, anti PD-1, anti CTLA-4) ;
- Symptomatic central nervous system (CNS) metastasis.
- History of concurrent serious cerebro- and cardiovascular diseases including but not limited to: unstable angina pectoris, myocardial infarction, cerebrovascular accident or transient ischemic attack within 6 months prior to the first doses, poorly controlled hypertension or arrhythmia, or any other arterial thrombosis or embolic event;
Show all 19Show fewer
- History of concurrent gastrointestinal diseases including but not limited to: gastrointestinal bleeding or perforation, acute pancreatitis;
- History of concurrent lung damage including but not limited to: interstitial lung disease, other diseases requiring oxygen inhalation.
- Presence of active pneumonia or history of noninfectious pneumonia;
- Active infection requiring systematic treatment/antibiotics or intravenous use of systemic anti-infection therapy with one week prior to the first dose or use for more than 7 days;
- Known positive for human immunodeficiency virus (HIV); Having evidence on infection of hepatitis C virus (HCV) or syphilis; Hepatitis B virus (HBV) infected individuals with positive HBsAg and HBV DNA copy >1000 IU/ml or 200 cps/mL; Following treatment according to guidelines, previously HBV infected individuals in screening period can be enrolled only;
- Presence of active or suspicious autoimmune disease.
- Previous allogeneic bone marrow transplantation or solid organ transplantation;
- Major surgery (judged by investigators) or in the recovery period of the surgery within 4 weeks before the first dose of QLS31904.
- Vaccination of live attenuated vaccine within 4 weeks prior to the first dose of QLS31904;
- Having other malignant tumor other than the disease investigated within 2 years prior to the ICF;
- Known allergy to any component of QLS31904;
- Any other disease or condition of clinical significance that can affect the compliance with the protocol (e.g., history of psychosis or drug abuse), affect the signature of the informed consent form (e.g., drug addiction and drug abuse);
- Any condition is unsuitable to be involved in this clinical trial, as considered by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jilin Cancer Hospital
Changchun, Jilin, 132000
About this study
Official title: An Open-label, Phase 1 Study of QLS31904 as Monotherapy to Assess the Safety, Tolerability and PK in Patients With Advanced Solid Tumors
This is an open label, phase 1 clinical study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) of QLS31904 q2w/q3w intravenous use in patients with advanced solid tumors. Additional objectives are to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals. This study is consisted of phase Ia (Dose Escalation) and phase Ib (Dose Expansion). Phase Ib will further explore QLS31904 in selected patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.
- Conditions
- Advanced Solid Tumor
- Being tested
- QLS31904
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS31904Drug
QLS31904 ONLY
| Study group | Role | What they receive |
|---|---|---|
| QLS31904 | Experimental | Qls31904 is a bi-specific recombinant protein construct containing 2 humanized antibody derived binding domains. Receives: Drug: QLS31904 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT
Dose-limiting toxicity (DLT) is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 28 days after the first dose.
Measured: Up to 28 approximately days
MTD
The maximum tolerated dose (MTD) is defined as the highest dose at which DLT occurs in <1/3 subjects.
The maximum administrated dose (MAD) is defined as the highest dose of all groups if MTD can not be determined.
Measured: Up to 24 approximately months
RP2D
Recommended dose for phase II trials
Measured: Up to 24 approximately months
Secondary outcomes (22)
Incidence of adverse event (AE)
Incidence of adverse events (AE) assessed according to NCI-CTCAE 5.0 Incidence of adverse events (AE) assessed according to NCI-CTCAE 5.0
Measured: Up to 24 approximately months
Severity of adverse event (AE)
Severity of adverse events (AE) assessed according to NCI-CTCAE 5.0
Measured: Up to 24 approximately months
Incidence of serious adverse event (SAE)
Incidence of serious adverse event (SAE) assessed according to NCI-CTCAE 5.0
Measured: Up to 24 approximately months
Severity of serious adverse event (SAE)
Severity of serious adverse events (AE) assessed according to NCI-CTCAE 5.0
Measured: Up to 24 approximately months
Incidence of immune related adverse event (irAE)
Incidence of immune related adverse event (irAE) assessed according to NCI-CTCAE 5.0
Measured: Up to 24 approximately months
Incidence of clinically significant laboratory examination and abnormal changes in other examinations
Incidence of clinically significant laboratory examination and abnormal changes in other examinations assessed according to NCI-CTCAE 5.0
Measured: Up to 24 approximately months
peak concentration (Cmax)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters peak concentration (Cmax);
Measured: Up to 24 approximately months
time to peak (Tmax)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters time to peak (Tmax);
Measured: Up to 24 approximately months
trough concentration (Ctrough)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters trough concentration (Ctrough)
Measured: Up to 24 approximately months
area under the plasma drug concentration-time curve (AUC0-t )
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-t )
Measured: Up to 24 approximately months
area under the plasma drug concentration-time curve (AUC0-inf)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters area under the plasma drug concentration-time curve (AUC0-inf);
Measured: Up to 24 approximately months
volume of distribution (Vss)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters volume of distribution (Vss)
Measured: Up to 24 approximately months
elimination half-life (t1/2)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters elimination half-life (t1/2)
Measured: Up to 24 approximately months
clearance rate (CL)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters clearance rate (CL);
Measured: Up to 24 approximately months
mean retention time (MRT)
Pharmacokinetic (PK) profile: drug concentration in individual subject at different time points after administration; pharmacokinetic parameters mean retention time (MRT)
Measured: Up to 24 approximately months
ORR
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria, including objective response rate (ORR).
Measured: Up to 24 approximately months
DOR
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including duration of response (DOR);
Measured: Up to 24 approximately months
DCR
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including disease control rate (DCR);
Measured: Up to 24 approximately months
PFS/PFS6
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including progression-free survival (PFS) and percents of progression-free survival more than six months;
Measured: Up to 24 approximately months
OS
The efficacy evaluated by the investigator in accordance with RECIST 1.1 criteria24, including overall survival (OS);
Measured: Up to 24 approximately months
ADA
incidence of anti-drug body (ADA)
Measured: Up to 24 approximately months
Nab
concentration of neutralizing antibody (Nab);
Measured: Up to 24 approximately months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start30 Sep 2022
- Primary completion25 Sep 2024 (estimated)
- Study completion25 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies 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
- 290 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
- NCT05461287
- Sponsor's protocol ID
- QLS31904-101
- Status last verified
- Nov 2022
- First submitted
- 13 Jul 2022
- Last updated
- 10 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Phase 1 Study of QLS31904 as Monotherapy to Assess the Safety, Tolerability and PK in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05461287
- Acronym / sponsor ID
- QLS31904-101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 25 Sep 2024 (estimated)
- Study completion
- 25 May 2025 (estimated)
- First posted
- 18 Jul 2022 (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 an open label, phase 1 clinical study to evaluate the safety, tolerability, dose limiting toxicities (DLTs), maximum tolerated dose (MTD) or maximum administered dose (MAD) and recommended phase 2 dose (RP2D) of QLS31904 q2w/q3w intravenous use in patients with advanced solid tumors. Additional objectives are to characterise pharmacokinetics and pharmacodynamics, and to evaluate efficacy signals. This study is consisted of phase Ia (Dose Escalation) and phase Ib (Dose Expansion). Phase Ib will further explore QLS31904 in selected patients populations based on data from phase Ia. The Phase Ib objectives, endpoints and design will be specified in a study protocol amendment after availability of phase Ia results.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLS31904 | Experimental | Drug: QLS31904Qls31904 is a bi-specific recombinant protein construct containing 2 humanized antibody derived binding domains. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Understanding and voluntarily signing the informed consent form;
- Male or female, age≥18 years;
- Patients with histologically or cytologically confirmed advanced solid tumors including small cell lung cancer, small cell cancers in other organs or neuroendocrine carcinoma who have progression after on theor intolerance to standard of care, or have no effective standard therapeutic regimen;
- Tumours must be confirmed expression of DLL3.
- Presence of at least one measurable lesion meeting the requirements in RECIST v1.1 evaluation criteria;
Key exclusion criteria (19 listed)
- Having received the treatment targeting CD3 or DLL3 previously;
- Receiving any systematic antitumor therapy or other investigational product within 4 weeks prior to the first dose of QLS31904;
- Receiving radiotherapy within 2 weeks prior to the first dose of QLS31904;
- For the dose-escalation, participants who experienced severe immune-mediated AEs while on treatment with Immune checkpoint inhibitors (e.g., anti PD-L1, anti PD-1, anti CTLA-4) ;
- Symptomatic central nervous system (CNS) metastasis.
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 |
|---|---|---|
| QLS31904QLS31904 ONLY | Drug | QLS31904 |
Primary outcome
DLT
Time frame: Up to 28 approximately days
Dose-limiting toxicity (DLT) is defined as any of the specified toxicities evaluated as at least possibly related with the study drug within 28 days after the first dose.
MTD
Time frame: Up to 24 approximately months
The maximum tolerated dose (MTD) is defined as the highest dose at which DLT occurs in <1/3 subjects. The maximum administrated dose (MAD) is defined as the highest dose of all groups if MTD can not be determined.
RP2D
Time frame: Up to 24 approximately months
Recommended dose for phase II trials
22 secondary outcomes
Incidence of adverse event (AE)
Time frame: Up to 24 approximately months
Severity of adverse event (AE)
Time frame: Up to 24 approximately months
Incidence of serious adverse event (SAE)
Time frame: Up to 24 approximately months
Severity of serious adverse event (SAE)
Time frame: Up to 24 approximately months
Incidence of immune related adverse event (irAE)
Time frame: Up to 24 approximately months
Incidence of clinically significant laboratory examination and abnormal changes in other examinations
Time frame: Up to 24 approximately months
peak concentration (Cmax)
Time frame: Up to 24 approximately months
time to peak (Tmax)
Time frame: Up to 24 approximately months
trough concentration (Ctrough)
Time frame: Up to 24 approximately months
area under the plasma drug concentration-time curve (AUC0-t )
Time frame: Up to 24 approximately months
area under the plasma drug concentration-time curve (AUC0-inf)
Time frame: Up to 24 approximately months
volume of distribution (Vss)
Time frame: Up to 24 approximately months
elimination half-life (t1/2)
Time frame: Up to 24 approximately months
clearance rate (CL)
Time frame: Up to 24 approximately months
mean retention time (MRT)
Time frame: Up to 24 approximately months
ORR
Time frame: Up to 24 approximately months
DOR
Time frame: Up to 24 approximately months
DCR
Time frame: Up to 24 approximately months
PFS/PFS6
Time frame: Up to 24 approximately months
OS
Time frame: Up to 24 approximately months
ADA
Time frame: Up to 24 approximately months
Nab
Time frame: Up to 24 approximately months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
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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. This study is not recruiting at the moment.
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 QLS31904 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 8 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 10 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huayuan Wang (008610-50813552, huayuan.wang@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT (time frame: Up to 28 approximately days). 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?
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 10 Nov 2022.