Advanced Solid TumorPhase 1NCT05801094
A Phase I Study of QL1604 for Advanced Solid Tumors
A Phase 1 study testing QL1604 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 2 sites in China.
Trial summary
In this study, patients with advance solid tumors will be treated with QL1604 monotherapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- QL1604
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 2 sitesChina
- Study dates
- 20 Jul 2020to 15 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years;
- At least one measureable lesion as defined per RECIST Version (v) 1.1
- Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis
- Adequate important organ function
Who cannot join
- Active autoimmune disease orautoimmune disease history
- Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of > 10 mg/day or equivalent hormone) for more than 2 weeks)
- Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients
- Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks)
- Active hepaititis B or C infection
- Both HBsAg and anti-HCV Ab positive
Trial locations and contacts
2 sites in 1 country.
China2 sites
The First Affliated Hospital of Nanchang University
Nanchang
Fudan University Shanghai Cancer Center
Shanghai
About this study
Official title: A Phase I Clinical Study to Evaluate Safety、 Tolerability, and Pharmacokinetics of QL1604 for the Treatment of Advanced Solid Tumors - A Phase Ic Preliminary Efficacy Expansion Study
In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.
- Conditions
- Advanced Solid Tumor
- Being tested
- QL1604
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1604Drug
QL1604 3 mg/kg Q3W
| Study group | Role | What they receive |
|---|---|---|
| QL1604 | Experimental | Not described Receives: Drug: QL1604 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.
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 posted6 Apr 2023
- Study start20 Jul 2020
- Primary completion15 Apr 2023 (estimated)
- Study completion15 Dec 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 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
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weijian Guo, PhD, Study chair, Fudan UniversityJianping Xiong, PhD, Study chair, The First Affliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801094
- Sponsor's protocol ID
- QL1604-002
- Status last verified
- Mar 2023
- First submitted
- 24 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xiong J, Ouyang W, Yang M, Gao Z, Zhou H, Lou H, Guo Y, Xu Z, Zheng L, Liu Y, Wang Z, Sun P, Niyazi H, Wang J, Chen Y, Zhang B, Li L, Kang X, Guo W. Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study. Adv Ther. 2024 Nov;41(11):4153-4171. doi: 10.1007/s12325-024-02981-z. Epub 2024 Sep 14.
PubMed 39276185
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Study to Evaluate Safety、 Tolerability, and Pharmacokinetics of QL1604 for the Treatment of Advanced Solid Tumors - A Phase Ic Preliminary Efficacy Expansion Study
- ClinicalTrials.gov ID
- NCT05801094
- Acronym / sponsor ID
- QL1604-002
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 15 Apr 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 6 Apr 2023 (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.
In this study, patients with advance solid tumors will be treated with QL1604 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QL1604 | Experimental | Drug: QL1604 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18-75 years;
- At least one measureable lesion as defined per RECIST Version (v) 1.1
- Histologically or cytologically confirmed、failed to standard therapy or lack standard therapy(except immunotherapy) advanced solid tumors; for cervical cancer, only squamous carcinoma、adenocarcinoma、adenosquamous carcinoma could be enrolled； hepatocellular carcinoma could be enrolled by clinical diagnosis
- Adequate important organ function
Key exclusion criteria (6 listed)
- Active autoimmune disease orautoimmune disease history
- Meningeal metastasis,or brain metastasis( except asymptomatic brain metastasis, or symptomatic brain metastasis but stable for more than 4 weeks after treatment, and have stopped systemic hormone treatment (prednisone of > 10 mg/day or equivalent hormone) for more than 2 weeks)
- Known hypersensitivity to protein macromolecules, and/or any of QL1604 excipients
- Radiotherapy, chemotherapy, hormone therapy, surgery, targeted therapy within 4 weeks prior to study drug (for micromolecule targeted therapy, within 2 weeks)
- Active hepaititis B or C infection
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 |
|---|---|---|
| QL1604QL1604 3 mg/kg Q3W | Drug | QL1604 |
Primary outcome
Objective response rate (ORR)
Time frame: up to 2 years
ORR is defined the percentage of the participants who have achieved complete response (CR) or partial response (PR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 after the initiation of study treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Derived from this study: PubMed 39276185Xiong J, Ouyang W, Yang M, Gao Z, Zhou H, Lou H, Guo Y, Xu Z, Zheng L, Liu Y, Wang Z, Sun P, Niyazi H, Wang J, Chen Y, Zhang B, Li L, Kang X, Guo W. Efficacy and Safety of Iparomlimab, an Anti-PD-1 Antibody, in Patients with Advanced Solid Tumors: A Phase 1c Study. Adv Ther. 2024 Nov;41(11):4153-4171. doi: 10.1007/s12325-024-02981-z. Epub 2024 Sep 14.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingPhase 1
A Study of MGC030 in Participants With Advanced Solid Tumors
Urothelial Cancer, GastroEsophageal Cancer
RecruitingPhase 1
SW-682 in Advanced Solid Tumors
Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingPhase 1
Study of XB010 in Subjects With Solid Tumors
Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer
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.
Weijian Guo, PhD study chair
Fudan University
Jianping Xiong, PhD study chair
The First Affliated Hospital of Nanchang University
2 sites 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 in people with Advanced Solid Tumor, run by Qilu Pharmaceutical Co., Ltd. at 2 sites 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 4 inclusion and 6 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Objective response rate (ORR) (time frame: up to 2 years). 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 NCT05801094, 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 6 Apr 2023.