Advanced MelanomaPhase 2NCT05114603
A Phase II Clinical Trial to Evaluate HLX208 in Advanced Melanoma Patients With BRAF V600 Mutation
A Phase 2 study testing HLX208 in people with Advanced Melanoma, run by Shanghai Henlius Biotech at 7 sites in China.
Trial summary
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Melanoma
- What is being tested?
- HLX208
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesChina
- Study dates
- 21 Mar 2022to 30 Aug 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
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- advanced melanoma with BRAF V600 mutation that have been diagnosed
- ECOG score 0-1;
Who cannot join
- Previous treatment with BRAF inhibitors or MEK inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has beenon > treatment for 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).
- Severe active infections requiring systemic anti-infective therapy
- A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Peking University Cancer Hospita
Beijing, Beijing Municipality, 100142
Lu Si, MD PhD, silu15_silu@126.com
- Recruiting
Hunan cancer hospital
Changsha
Xingxiang Pu, puxingxiang@hnca.org.cn
- Not yet recruiting
West China Hospital of Sichuan University
Chendu
Jiyan Liu, liujiyan1972@163.com
- Not yet recruiting
Fujian cancer hospital
Fujian
Yu Chen, 13859089836@136.com
- Not yet recruiting
Shangxi Bethune Hospita
Taiyuan
Huijing feng
- Not yet recruiting
union Hospital Tongji Medical College, Huazhong University of Science and Technology
Wuhan
Jing Chen, bswhunion@163.com
- Not yet recruiting
Henan cancer hospital
Zhengzhou
Weitao Yao, ywtwhm@163.com
About this study
Official title: An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
- Conditions
- Advanced Melanoma
- Being tested
- HLX208
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX208Drug
level 1:600mg po Bid level 2:900mg po Bid
| Study group | Role | What they receive |
|---|---|---|
| Dose-escalation stage | Experimental | Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding. Receives: Drug: HLX208 |
| Dose-expansion stage | Experimental | Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208. Receives: Drug: HLX208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)
Measured: from first dose to the last patient was followed up for 6 month
Secondary outcomes (3)
PFS
Progression-free survival(PFS):assessed by IRRC and the investigator based on the RECIST Version 1.1
Measured: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years
DOR
Duration of response
Measured: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years
OS
Overall survival
Measured: from the first dose to the time of death due to any cause，assessed 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 posted10 Nov 2021
- Study start21 Mar 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MelanomaStudies of the same condition, open and under way.
- More trials run by Shanghai Henlius BiotechThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05114603
- Sponsor's protocol ID
- HLX208-MEL201
- Status last verified
- Oct 2021
- First submitted
- 29 Oct 2021
- Last updated
- 3 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase II Clinical Study to Evaluate Safety, Efficacy and PK of HLX208 for Advanced Melanoma With BRAF V600 Mutation
- ClinicalTrials.gov ID
- NCT05114603
- Acronym / sponsor ID
- HLX208-MEL201
- Conditions
- Advanced Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2024 (estimated)
- First posted
- 10 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.
An open-label, multicenter phase II clinical study to evaluate safety, efficacy and PK of HLX208 for advanced melanoma with BRAF V600 mutation
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose-escalation stage | Experimental | Drug: HLX208Iinvestigate the safety and determine the MTD of HLX208. Two dose levels of 600mg and 900 mg are planned for dose finding. |
| Dose-expansion stage | Experimental | Drug: HLX208Patients with advanced melanoma will be enrolled in two expansion cohorts, at doses equal to or lower than the MTD, to better characterize the safety, tolerability, PK variability, and preliminary efficacy of single-agent HLX208. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age>=18Y
- Good Organ Function
- Expected survival time ≥ 3 months
- advanced melanoma with BRAF V600 mutation that have been diagnosed
- ECOG score 0-1;
Key exclusion criteria (4 listed)
- Previous treatment with BRAF inhibitors or MEK inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has beenon > treatment for 3 months, has no evidence of progress on imagingwithin 4 weeks prior to initial administration, and tumor-related clinicalsymptoms are stable).
- Severe active infections requiring systemic anti-infective therapy
- A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
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 |
|---|---|---|
| HLX208level 1:600mg po Bid level 2:900mg po Bid | Drug | Dose-escalation stage, Dose-expansion stage |
Primary outcome
ORR
Time frame: from first dose to the last patient was followed up for 6 month
Objective response rate(assessed by independent radiological review committee (IRRC) based on the e RECIST Version 1.1)
3 secondary outcomes
PFS
Time frame: from the first dose until firstly confirmed and recorded disease progression or death (whichever occurs earlier)，assessed up to 1 years
DOR
Time frame: from the first occurrence of a documented CR or PR (whichever recorded earlier) to the time of first documented disease progression or death (whichever occurs first) assessed up to 1 years
OS
Time frame: from the first dose to the time of death due to any cause，assessed 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 3 May 2022.
- Individual participant dataSharing planned: No
Related trials for Advanced Melanoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
A Study of Dapansutrile Plus Pembrolizumab in Patients With PD-1 Refractory Advanced Melanoma
Melanoma
RecruitingPhase 3
A Study With Combinations of Anti-LAG-3 and Anti-PD-1 Antibodies in Adult Participants With Advanced or Metastatic Melanoma (Harmony Head-to-Head)
Melanoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
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.
7 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 HLX208 in people with Advanced Melanoma, run by Shanghai Henlius Biotech at 7 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 5 inclusion and 4 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 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 (88196391, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: from first dose to the last patient was followed up for 6 month). 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 3 May 2022.