Advanced Solid TumorsPhase 1NCT05649761
A Phase I Study of QL1604 in Subjects With Advanced Solid Tumors
A Phase 1 study testing QL1604 injection in people with Advanced Solid Tumors, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection （a humanized anti-PD-1 monoclonal antibody）in patients with advanced… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- QL1604 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2019to 23 Jan 2023
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
- Age ≥ 18 years and ≤ 70 years when ICF is signed;
- Pts with histologically or cytologically confirmed advanced solid tumors;
- At least one target lesion as defined per RECIST Version (v) 1.1;
- Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s) ;
- Eastern Cooperative Oncology Group performance status of 0 or 1;
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- Life expectancy of greater than 12 weeks;
- Adequate hematologic and organ function;
- Female subjects who are not pregnant or breastfeeding
- Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 120 days after last dose;
Who cannot join
- Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
- Active autoimmune disease that has required systemic treatment, replacement therapy is acceptable;
- Subjects with major cardiovascular and cerebrovascular diseases;
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
- Subjects who have received surgery, radiotherapy, chemotherapy, targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
- Received a live vaccine;
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- Infection with human immunodeficiency virus (HIV);
- Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
- History or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Cancer Hospital of The University of Chinese Academy of Sciences
Hangzhou, Zhejiang, 310022
About this study
Official title: A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QL1604, a Humanized Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors
This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection （a humanized anti-PD-1 monoclonal antibody）in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors
- Being tested
- QL1604 injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1604 injectionDrug
Participants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity.
| Study group | Role | What they receive |
|---|---|---|
| QL1604 injection | Experimental | Participants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity. Receives: Drug: QL1604 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
Dose-limiting toxicity (DLT)
Measured: Up to 21 days after the first dose
maximum tolerated dose(MTD)
maximum tolerated dose(MTD)
Measured: Up to 21 days after the first dose
recommended phase II dose (RP2D)
recommended phase II dose (RP2D)
Measured: up to 2 years
Secondary outcomes (7)
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs
according to NCI CTCAE V5.0
Measured: up to 2 years
Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants
Maximum Concentration (Cmax)
Measured: up to 2 years
Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants
Time to Maximum Concentration (Tmax)
Measured: up to 2 years
Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants
Terminal Half-Life (t ½)
Measured: up to 2 years
Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants
Area Under the Concentration-Time Curve
Measured: up to 22 days
Objective Response Rate (ORR) According to RECIST 1.1
Objective Response Rate (ORR) According to RECIST 1.1
Measured: up to 2 years
Disease Control Rate (DCR) According to RECIST 1.1
Disease Control Rate (DCR) According to RECIST 1.1
Measured: up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2022
- Study start29 May 2019
- Primary completion10 Jul 2020
- Study completion23 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT05649761
- Sponsor's protocol ID
- QL1604-001
- Status last verified
- Nov 2022
- First submitted
- 24 Nov 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Huang Z, Xu Y, Hong W, Gong L, Chen K, Qin J, Xie F, Wang F, Tian X, Meng X, Feng W, Li L, Zhang B, Kang X, Fan Y. A first-in-human, open-label, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of QL1604, a humanized anti-PD-1 mAb, in patients with advanced or metastatic solid tumors. Front Immunol. 2023 Oct 23;14:1258573. doi: 10.3389/fimmu.2023.1258573. eCollection 2023.
PubMed 37936687
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of QL1604, a Humanized Anti-PD-1 Monoclonal Antibody, in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05649761
- Acronym / sponsor ID
- QL1604-001
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 May 2019 (actual)
- Primary completion
- 10 Jul 2020 (actual)
- Study completion
- 23 Jan 2023 (estimated)
- First posted
- 14 Dec 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 a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection （a humanized anti-PD-1 monoclonal antibody）in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1604 injection | Experimental | Drug: QL1604 injectionParticipants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
- Age ≥ 18 years and ≤ 70 years when ICF is signed;
- Pts with histologically or cytologically confirmed advanced solid tumors;
- At least one target lesion as defined per RECIST Version (v) 1.1;
- Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s) ;
Key exclusion criteria (9 listed)
- Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
- Active autoimmune disease that has required systemic treatment, replacement therapy is acceptable;
- Subjects with major cardiovascular and cerebrovascular diseases;
- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
- Subjects who have received surgery, radiotherapy, chemotherapy, targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
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 |
|---|---|---|
| QL1604 injectionParticipants will receive QL1604 injection 0.3 mg/kg,1mg/kg, 3mg/kg,10mg/kg, or 200mg intravenous every 2 weeks or every 3 weeks and will be continued until disease progression or unacceptable toxicity. | Drug | QL1604 injection |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: Up to 21 days after the first dose
Dose-limiting toxicity (DLT)
maximum tolerated dose(MTD)
Time frame: Up to 21 days after the first dose
maximum tolerated dose(MTD)
recommended phase II dose (RP2D)
Time frame: up to 2 years
recommended phase II dose (RP2D)
7 secondary outcomes
Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs
Time frame: up to 2 years
Maximum Concentration (Cmax) of QL1604 in Solid Tumor Participants
Time frame: up to 2 years
Time to Maximum Concentration (Tmax) of QL1604 in Solid Tumor Participants
Time frame: up to 2 years
Terminal Half-Life (t ½) of QL1604 in Solid Tumor Participants
Time frame: up to 2 years
Area Under the Concentration-Time Curve of QL1604 From Time 0 to Day 28 (AUC 0-22) in Solid Tumor Participants
Time frame: up to 22 days
Objective Response Rate (ORR) According to RECIST 1.1
Time frame: up to 2 years
Disease Control Rate (DCR) According to RECIST 1.1
Time frame: up to 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Derived from this study: PubMed 37936687Huang Z, Xu Y, Hong W, Gong L, Chen K, Qin J, Xie F, Wang F, Tian X, Meng X, Feng W, Li L, Zhang B, Kang X, Fan Y. A first-in-human, open-label, dose-escalation and dose-expansion phase I study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics, and antitumor activity of QL1604, a humanized anti-PD-1 mAb, in patients with advanced or metastatic solid tumors. Front Immunol. 2023 Oct 23;14:1258573. doi: 10.3389/fimmu.2023.1258573. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 QL1604 injection in people with Advanced Solid Tumors, 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 9 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 14 Dec 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: Up to 21 days after 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 NCT05649761, which also lists 1 linked publication.
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 14 Dec 2022.