Advanced TumorPhase 1NCT05108779

QLF32004 Injection for the Treatment of Patients With Advanced Malignant Tumors

A Phase 1 study testing QLF32004 in people with Advanced Tumor, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

To determine the safety, tolerability, and recommended dose (RP2D) of QLF32004 in patients with advanced malignancies. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Advanced Tumor
What is being tested?: QLF32004
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteChina
Study dates: 9 Nov 2021to 30 Dec 2024
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age: 18-75 years old .
Patients with advanced malignant solid tumors confirmed histologically or cytologically have failed standard therapy, or have no standard therapy, or are not eligible for standard therapy at this stage.
(dose escalation phase) At least one assessable tumor focus according to RECIST 1.1;(PK expansion phase) According to RECIST 1.1, there is at least one measurable tumor lesion (a tumor lesion located in the area of previous radiotherapy or other local regional treatment site is generally not considered measurable unless the lesion shows definite progression or persists after 3 months of radiotherapy).
ECOG score 0-1.
Life expectancy ≥ 12 weeks.
Adequate organ function prior to the first use of the investigational drug (no use of any blood components, cell growth factor, colony stimulating factor (G-CSF), rhTPO, etc., or hepatoprotective therapy is permitted within 14 days prior to laboratory examination);
Eligible fertile patients (male and female) must agree to use a reliable contraceptive method (hormonal or barrier methods or abstinence, etc.) with their partner during the trial and for 6 months after the last medication;Women of reproductive age must have a negative blood pregnancy test within 7 days of their first use of the study drug;
Subjects shall give informed consent to this study before the test and voluntarily sign a written informed consent.

Who cannot join

Known allergy to the study drug or any excipients thereof; Or had a grade ≥3 allergic reaction to protein drugs in the past.
Had received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to the first use of the study drug.
Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the first use of the investigational drug.
Use of live attenuated vaccine within 4 weeks prior to initial use of the study drug.
Received systemic glucocorticoid or other immunosuppressant treatment within 14 days prior to initial use of the study drug.
Use of immunomodulatory drugs, including but not limited to thymosin.

Show all 15Show fewer

Had major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to initial use of the study drug, or required elective surgery during the study period.
Patients with cerebral parenchymal metastasis or meningeal metastasis with clinical symptoms were judged by the investigator to be unsuitable for inclusion;
Patients with uncontrollable exudation (thorax, pericardium, abdominal cavity);
Have received immunotherapy and present with grade ≥ 3 irAE or grade ≥2 immune-associated myocarditis;
Adverse reactions of previous antitumor therapy have not recovered to CTCAE 5.0 rating ≤1 (except toxicity without safety risk, such as hair loss, peripheral neurotoxicity of grade 2, hypothyroidism stabilized by hormone replacement therapy, etc.);
Presence or history of any active autoimmune disease;Subjects with skin diseases that do not require systemic treatment, such as vitiligo, psoriasis, hair loss, type I diabetes, or asthma that has been completely resolved in childhood and does not require any intervention as adults may be included;Asthma patients requiring medical intervention with bronchodilators were excluded;
Patients with previous or current interstitial lung disease;
Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); Active hepatitis B, active hepatitis C;
16. Have a history of serious cardiovascular and cerebrovascular diseases; 17. Have active infection and currently require intravenous anti-infection therapy; 18. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 19. The patient is known to have a history of psychotropic drug abuse, alcoholism or drug abuse;A clear past history of neurological or psychiatric disorders, including epilepsy or dementia; 20. Patients with other serious physical or mental disorders or abnormal laboratory tests that may increase the risk of study participation or interfere with study results, and who are considered unsuitable for study participation by the investigator.

Trial locations and contacts

1 site in 1 country.

Jin Li contact

021-38804518

sunypclinicaltrial@163.com

China1 site, 1 recruiting

Shanghai East Hospital
Shanghai, Shanghai Municipality, 200120
Jin Li, 021-38804518
Recruiting

Other trials in China

About this study

Official title: Phase Ia Clinical Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLF32004 for Injection Monotherapy in Patients With Advanced Malignant Tumors

To determine the safety, tolerability, and recommended dose (RP2D) of QLF32004 in patients with advanced malignancies.

Conditions: Advanced Tumor
Being tested: QLF32004

What participants receive

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

QLF32004Drug
In the phase, five dose groups were proposed.The frequency of administration was once a week, and the treatment cycle was 3 weeks.

Study groups in NCT05108779
Study group	Role	What they receive
QLF32004	Experimental	Not described Receives: Drug: QLF32004

What is being measured

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

Dose-Limiting Toxicity (DLT)
Measured: 21 days
Maximum Tolerated Dose (MTD)
Measured: 21 days
Recommended Phase 2 Dose (RP2D)
Measured: 12 month

Secondary outcomes (4)

Treatment-Emergent Adverse Event (TEAE)
Measured: 21 days
Maximum Observed Plasma Concentration (Cmax)
Measured: 21 days
Serious Adverse Event (SAE)
Measured: 12 month
Area Under The Curve (AUC)
Measured: 21 days

Timeline

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

9 Nov 202130 Dec 2024

First posted5 Nov 2021
Study start9 Nov 2021
Primary completion30 Dec 2024 (estimated)
Study completion30 Dec 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Advanced 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: Sequential
Masking: None (open label)
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05108779
Sponsor's protocol ID: QLF32004-101
Status last verified: Aug 2022
First submitted: 22 Oct 2021
Last updated: 28 Mar 2023
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 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase Ia Clinical Study of Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLF32004 for Injection Monotherapy in Patients With Advanced Malignant Tumors
ClinicalTrials.gov ID: NCT05108779
Acronym / sponsor ID: QLF32004-101
Conditions: Advanced Tumor
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 40 participants (estimated)
Lead sponsor: Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 9 Nov 2021 (actual)
Primary completion: 30 Dec 2024 (estimated)
Study completion: 30 Dec 2024 (estimated)
First posted: 5 Nov 2021 (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.

To determine the safety, tolerability, and recommended dose (RP2D) of QLF32004 in patients with advanced malignancies.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
QLF32004	Experimental	Drug: QLF32004

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Age: 18-75 years old .
Patients with advanced malignant solid tumors confirmed histologically or cytologically have failed standard therapy, or have no standard therapy, or are not eligible for standard therapy at this stage.
(dose escalation phase) At least one assessable tumor focus according to RECIST 1.1;(PK expansion phase) According to RECIST 1.1, there is at least one measurable tumor lesion (a tumor lesion located in the area of previous radiotherapy or other local regional treatment site is generally not considered measurable unless the lesion shows definite progression or persists after 3 months of radiotherapy).
ECOG score 0-1.
Life expectancy ≥ 12 weeks.

Key exclusion criteria (15 listed)

Known allergy to the study drug or any excipients thereof; Or had a grade ≥3 allergic reaction to protein drugs in the past.
Had received chemotherapy, radiotherapy, biotherapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks prior to the first use of the study drug.
Received any other investigational drug or treatment that is not on the market within 4 weeks prior to the first use of the investigational drug.
Use of live attenuated vaccine within 4 weeks prior to initial use of the study drug.
Received systemic glucocorticoid or other immunosuppressant treatment within 14 days prior to initial use of the study drug.

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
QLF32004In the phase, five dose groups were proposed.The frequency of administration was once a week, and the treatment cycle was 3 weeks.	Drug	QLF32004

Primary outcome

Dose-Limiting Toxicity (DLT)
Time frame: 21 days
Maximum Tolerated Dose (MTD)
Time frame: 21 days
Recommended Phase 2 Dose (RP2D)
Time frame: 12 month

4 secondary outcomes

Treatment-Emergent Adverse Event (TEAE)
Time frame: 21 days
Maximum Observed Plasma Concentration (Cmax)
Time frame: 21 days
Serious Adverse Event (SAE)
Time frame: 12 month
Area Under The Curve (AUC)
Time frame: 21 days

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.

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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.

Jin Li contact

021-38804518

sunypclinicaltrial@163.com

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 QLF32004 in people with Advanced 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 15 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 28 Mar 2023. 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 Jin Li (021-38804518, sunypclinicaltrial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: 21 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?

On the ClinicalTrials.gov record for NCT05108779.

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 28 Mar 2023.