Solid TumorPhase 1NCT04965220
HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
A Phase 1 study testing HLX 208 in people with Solid Tumor, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- HLX 208
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2022to 30 Jun 2025
- 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
- 18Y≤Age≤75Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
- Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
- ECOG score 0-1;
- Expected survival time of more than 3 months;
Who cannot join
- Previous treatment with BRAF inhibitors or MEK inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- Current or former patients with interstitial lung disease;
- Active clinical severe infection;
- A history of other malignancies within two years, except for cured carcinoma in situ of the cervix or basal cell carcinoma of the skin.
- Other anti-tumor treatments, such as chemotherapy, targeted therapy, or radiation therapy (except palliative radiation therapy), may be given during the study period.
Trial locations and contacts
1 site in 1 country.
Zhang Li, leading PI contact
Guo ye, PI contact
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, 510060
Li Zhang, zhangli@sysucc.org.cn
About this study
Official title: A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors
- Conditions
- Solid Tumor
- Being tested
- HLX 208
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX 208Drug
Also called trametinib
take orally
| Study group | Role | What they receive |
|---|---|---|
| ATC | Experimental | HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) Receives: Drug: HLX 208 |
| Primary brain tumor | Experimental | HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) Receives: Drug: HLX 208 |
| CRC(KRAS mutant) | Experimental | HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) Receives: Drug: HLX 208 |
| other solid tumor | Experimental | HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) Receives: Drug: HLX 208 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
maximum tolerated dose
Measured: from first dose to the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes (4)
RP2D
Recommended dose for phase II clinical trials
Measured: from first dose to the end of Cycle 1 (each cycle is 21 days)
Peak Plasma Concentration (Cmax) of HLX208
pharmacokinetics
Measured: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
ORR
The number of patients with CR or PR divided by the total number of treated patients whose disease was measurable at baseline
Measured: from first dose to the last patient was followed up for 6 month
Area under the plasma concentration versus time curve (AUC)of HLX208
pharmacokinetics
Measured: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2021
- Study start5 Jan 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 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
- NCT04965220
- Sponsor's protocol ID
- HLX208-MEK-001
- Status last verified
- Aug 2023
- First submitted
- 9 Jun 2021
- Last updated
- 9 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial Evaluating the Safety, Tolerability, Pharmacokinetics, and Initial Efficacy of HLX208 (BRAF V600E Inhibitor) in Combination With Trametinib in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04965220
- Acronym / sponsor ID
- HLX208-MEK-001
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 16 Jul 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.
A phase I clinical trial evaluating the safety, tolerability, pharmacokinetics, and initial efficacy of HLX208 (BRAF V600E inhibitor) in combination with trametinib in patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ATC | Experimental | Drug: HLX 208HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) |
| Primary brain tumor | Experimental | Drug: HLX 208HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) |
| CRC(KRAS mutant) | Experimental | Drug: HLX 208HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) |
| other solid tumor | Experimental | Drug: HLX 208HLX208 (dose of RP2D) and trametinib 2mg qd ,orally,Continuation of treatment until progression, withdrawal of informed consent, intolerant toxicity (whichever occurs first) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18Y≤Age≤75Y
- Good Organ Function
- Expected survival time ≥ 3 months
- Metastatic/recurrent advanced BRAF+ solid tumors that have been diagnosed histologically and have failed standard treatment
- Previous failure to standard treatment, intolerance to standard treatment, absence of standard treatment, or insuitability for standard treatment at this stage.
Key exclusion criteria (6 listed)
- Previous treatment with BRAF inhibitors or MEK inhibitors
- Symptomatic brain or meningeal metastases (unless the patient has been on > treatment for 6 months, has no evidence of progress on imaging within 4 weeks prior to initial administration, and tumor-related clinical symptoms are stable).
- Current or former patients with interstitial lung disease;
- Active clinical severe infection;
- 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 |
|---|---|---|
| HLX 208Also: trametinibtake orally | Drug | ATC, CRC(KRAS mutant), Primary brain tumor, other solid tumor |
Primary outcome
MTD
Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
maximum tolerated dose
4 secondary outcomes
RP2D
Time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)
Peak Plasma Concentration (Cmax) of HLX208
Time frame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
ORR
Time frame: from first dose to the last patient was followed up for 6 month
Area under the plasma concentration versus time curve (AUC)of HLX208
Time frame: from first dose to the beginning of Cycle 4 (each cycle is 21 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
- Individual participant dataSharing planned: Yes
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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.
Zhang Li, leading PI contact
Guo ye, PI contact
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 HLX 208 in people with Solid Tumor, run by Shanghai Henlius Biotech 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 7 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 9 Aug 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 Zhang Li, leading PI (zhangli@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: from first dose to the end of Cycle 1 (each cycle is 21 days)). 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 9 Aug 2023.