MelanomaPhase 2NCT05823246
Safety and Efficacy Study of QLF31907 in Advanced Melanoma and Urothelial Carcinoma
A Phase 2 study testing QLF31907 in people with Melanoma and Urothelial Carcinoma, run by Qilu Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
This study will assess the safety, tolerability and efficacy of every-2-week dosing of QLF31907 injection in patients with advanced melanoma and urothelial carcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanoma, Urothelial Carcinoma
- What is being tested?
- QLF31907
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 6 sitesChina
- Study dates
- 24 Apr 2023to Jul 2024
- Phase
- Phase 2
- 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
- Subjects voluntarily participated and signed a written informed consent form
- Age ≥ 18 years, male or female
- ECOG performance status of 0 or 1
- Expected life-expectancy ≥ 3 months
- Histologically confirmed diagnosis of locally advanced or metastatic unresectable melanoma or urothelial carcinoma, failed or intolerant or rejected to standard therapy
- Patients must have at least one measurable lesion according to RECIST v1.1
- Adequate organ function prior to QLF31907 administration
- All subjects of reproductive potential must agree to use an effective method of contraception during the study and for 180 days after the last dose, and women of reproductive age must have a negative blood pregnancy result within 7 days prior to the first dose.
Who cannot join
- Prior treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
- Known to be allergic to any excipients of QLF31907 or a history of severe allergic reactions to other monoclonal antibodies
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or autologous stem cell transplantation within 180 days
- Known history of cytotherapy or antitumor vaccine or other antitumor therapy or surgical treatment of main organs within 4 weeks
- Known history of systemic glucocorticoid therapy or other immunosuppressants within 14 days
- Active central nervous system (CNS) metastases
Show all 16Show fewer
- Known history of other active malignant tumor within 3 years, unless completely cured
- With uncontrolled or clinically symptomatic pleural, pericardial or abdominal effusions
- An active infectious disease requiring intravenous antibiotic therapy
- Failure to recover to grade 1 from adverse reactions due to prior treatment according to CTCAE v5.0
- An active autoimmune diseases or known history of ≥ grade 3 irAE due to prior immunotherapy
- Known history of active hepatitis B/C infection, severe cardiovascular and cerebrovascular disease, idiopathic pulmonary fibrosis, pneumoconiosis, asbestosis, hepatitis (nonalcoholic steatohepatitis, alcoholic or autoimmune hepatitis), cirrhosis, active tuberculosis, active syphilis, HIV infection
- Poorly controlled respiratory, circulatory or endocrine diseases
- Known history of drugs abuse, alcoholism, neurologic or psychiatric disorders
- Patients who are breastfeeding
- Other serious physical or psychiatric illnesses or laboratory abnormalities that may increase the risk of participating in the study, or interfere with the results of the study, and patients who are not suitable for participation in this study in the opinion of the investigator
Trial locations and contacts
6 sites in 1 country.
Lu Si, MD contact
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing, Beijing Municipality, 100142
Lu Si, MD, 010-88121122, silu15_silu@126.com
Jun Guo, MD
- Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130021
Xueying Zhang
- Not yet recruiting
The First Hospital of Jilin University
Changchun, Jilin, 130021
Di Wu
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Haixia Zhang
- Not yet recruiting
West China Hospital
Chengdu, Sichuan, 610041
Jiyan Liu
- Not yet recruiting
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Yu Chen
About this study
Official title: A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma
This study will assess the safety, tolerability and efficacy of every-2-week dosing of QLF31907 injection in patients with advanced melanoma and urothelial carcinoma.
Read the detailed description
This study is divided into two parts. The first part is the safety and tolerability observation period, mainly observing the safety and tolerability of QLF31907. The second part is mainly the efficacy observation period, further evaluating the efficacy and safety of QLF31907 in patients with advanced melanoma and urothelial carcinoma.
- Conditions
- Melanoma, Urothelial Carcinoma
- Being tested
- QLF31907
- Medical subject headings
- Melanoma, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLF31907Drug
Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1.
| Study group | Role | What they receive |
|---|---|---|
| QLF31907 | Experimental | single arm with QLF31907 Receives: Drug: QLF31907 |
What is being measured
The primary outcome is the main question the study is designed to answer.
(part 1)Dose-limiting toxicity(DLT)
Measured: 28days
(part 2) Objective response rate(ORR)
Measured: up to 2 years
Secondary outcomes (5)
(part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)
Measured: up to 2 years
(part 2) Progression-free survival(PFS)
Measured: up to 2 years
(part 2) Overall survival(OS)
Measured: up to 2 years
(part 2) Maximum observed plasma concentration (Cmax)
Measured: up to 2 years
(part 2) Positive rate of anti-drug antibody(ADA)
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 posted21 Apr 2023
- Study start24 Apr 2023
- Primary completionOct 2023 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelanomaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 66 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
- NCT05823246
- Sponsor's protocol ID
- QLF31907-201
- Status last verified
- Apr 2023
- First submitted
- 10 Mar 2023
- Last updated
- 26 May 2023
- 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 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study to Evaluate the Efficacy and Safety of QLF31907 Injection in Patients With Advanced Melanoma and Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT05823246
- Acronym / sponsor ID
- QLF31907-201
- Conditions
- Melanoma, Urothelial Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 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.
This study will assess the safety, tolerability and efficacy of every-2-week dosing of QLF31907 injection in patients with advanced melanoma and urothelial carcinoma.
Detailed description
This study is divided into two parts. The first part is the safety and tolerability observation period, mainly observing the safety and tolerability of QLF31907. The second part is mainly the efficacy observation period, further evaluating the efficacy and safety of QLF31907 in patients with advanced melanoma and urothelial carcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QLF31907 | Experimental | Drug: QLF31907single arm with QLF31907 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participated and signed a written informed consent form
- Age ≥ 18 years, male or female
- ECOG performance status of 0 or 1
- Expected life-expectancy ≥ 3 months
- Histologically confirmed diagnosis of locally advanced or metastatic unresectable melanoma or urothelial carcinoma, failed or intolerant or rejected to standard therapy
Key exclusion criteria (16 listed)
- Prior treatment with 4-1BB agonist or 4-1BB recombinant fusion protein
- Known to be allergic to any excipients of QLF31907 or a history of severe allergic reactions to other monoclonal antibodies
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation, or autologous stem cell transplantation within 180 days
- Known history of cytotherapy or antitumor vaccine or other antitumor therapy or surgical treatment of main organs within 4 weeks
- Known history of systemic glucocorticoid therapy or other immunosuppressants within 14 days
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 |
|---|---|---|
| QLF31907Intravenous infusion once every two weeks. The dose administered in part 2 will depend on the outcome of part 1. | Drug | QLF31907 |
Primary outcome
(part 1)Dose-limiting toxicity(DLT)
Time frame: 28days
(part 2) Objective response rate(ORR)
Time frame: up to 2 years
5 secondary outcomes
(part 2) Safety index: adverse event(AE), serious adverse event (SAE), treatment-related adverse event(TRAE)
Time frame: up to 2 years
(part 2) Progression-free survival(PFS)
Time frame: up to 2 years
(part 2) Overall survival(OS)
Time frame: up to 2 years
(part 2) Maximum observed plasma concentration (Cmax)
Time frame: up to 2 years
(part 2) Positive rate of anti-drug antibody(ADA)
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 26 May 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.
Lu Si, MD contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLF31907 in people with Melanoma and Urothelial Carcinoma, run by Qilu Pharmaceutical Co., Ltd. at 6 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 8 inclusion and 16 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 26 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jun Guo, MD (010-88121122, Guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(part 1)Dose-limiting toxicity(DLT) (time frame: 28days). The study lists 2 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 26 May 2023.