Non Small Cell Lung CancerPhase 1/2NCT05641493
A Phase Ib/II Clinical Trial to Evaluate the Safety and Efficacy of HLX208+HLX10 in NSCLC With BRAF V600E Mutation
A Phase 1/2 study testing HLX208+HLX10 in people with Non Small Cell Lung Cancer, run by Shanghai Henlius Biotech at 1 site in China.
Trial summary
An open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 （anti-PD-1 monoclonal antibody）in advanced NSCLC patients with BRAF V600 mutation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer
- What is being tested?
- HLX208+HLX10
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2023to 27 Feb 2026
- Phase
- Phase 1/2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 and ≤75 years old of age (in phase Ib study) or ≥18 and ≤80 years old of ag (in phase II study) at the time of informed consent.
- Signed written informed consent.
- BRAF V600E mutant advanced solid tumors (in phase Ib study) or advanced NSCLC (in phase II study) patients with positive PD-L1 expression (TPS or TC≥1%).
- Previous failure of standard therapy, intolerance to standard therapy, lack of standard therapy, or currently unsuitable for standard therapy.
- Prior systemic anti-neoplastic therapy (chemotherapy, radiotherapy, targeted therapy, or traditional Chinese medicine with anti-neoplastic indications) must have been ≥ 2 weeks from the first dose in this study with treatment-related AE resolved to NCI-CTCAE Grade ≤ 1 (except for alopecia)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
Show all 11Show fewer
- Expected survival time ≥ 3 months.
- At least one measurable target lesion per RECIST v1.1 (brain metastasis could not be considered as the only measurable lesion).
- With normal major organ functions (no blood transfusions or treatment with colony-stimulating factor within 14 days prior to the first dose in this study).
- Be able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bow
- Fertile subjects (male or female) must agree to take effective contraceptive measures from the time of signing the ICF until 90 days after the last dose of HLX208 or 6 months after the last dose of HLX10. Female subjects of childbearing potential must complete a pregnancy test with a negative result within 7 days prior to the first dose.
Who cannot join
- For subjects in phase II study: previous treatment with BRAF inhibitors or MEK inhibitors or previous treatment with T cell co-stimulation or immune checkpoint therapy.
- Known EGFR mutations or ALK rearrangements (except in subjects with EGFR mutations whose disease has progressed after previous EGFR inhibitor treatment).
- Received strong CYP3A inhibitors or inducers treatment within 1 week prior to the first dose of investigational product.
- Received major surgery within 28 days prior to the first dose of investigational product. A major surgery is defined as a surgery that takes at least 3 weeks of postoperative recovery before receiving treatment in this study.
- With uncontrolled pleural effusion, pericardial effusion, or ascites.
- With symptomatic brain or meningeal metastases (unless the patient has been treated for >3 months, there is no evidence of progression on imaging within 4 weeks prior to the first dose, and the tumor-related clinical symptoms are stable).
Show all 19Show fewer
- With active pulmonary tuberculosis. Patients with previous and current interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severe impaired pulmonary function that may interfere with the detection and management of suspected drug-related pulmonary toxicity.
- With any serious infection requiring systemic anti-infective therapy within 14 days prior to the first dose of the investigational product.
- History of other malignant tumors (except for cured carcinoma in situ of the cervical or basal cell carcinoma of the skin) within two years prior to the first dose of investigational product.
- Being positive (+) for hepatitis B surface antigen (HBsAg) or positive (+) for hepatitis B core antibody (HBcAb), and with hepatitis B virus deoxyribonucleic acid (HBV-DNA) ≥ 2500 copies/mL or 500 IU/mL.
- Being positive (+) for HCV RNA.
- Being positive (+) human immunodeficiency virus (HIV) antibody.
- History of serious cardiovascular and cerebrovascular diseases.
- Systemic treatment with corticosteroids (> 10 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose of the investigational product or during the study. In the absence of active autoimmune disease, subjects are allowed to use inhaled or topical steroids, or adrenal hormone replacement therapy at an effective dose equivalent to ≤10 mg/day prednisone.
- Known active or suspected autoimmune diseases. Subjects with autoimmune related hypothyroidism receiving thyroid hormone replacement therapy are allowed to participate in the study. Subjects with stable type 1 diabetes receiving insulin therapy are allowed to participate in the study.
- Known alcohol of or drug abuse.
- Pregnant or lactating women.
- Received live vaccine within 28 days prior to the first dose of investigational product.
- Have other conditions not suitable for inclusion as judged by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai Chest Hospital, Shanghai Jiao Tong University, School of Medicine
Shanghai
Shun Lu, Dr., 021-22200000, shunlu@sjtu.edu.cn
About this study
Official title: A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX208 （BRAF V600E Inhibitor） Combined With Serplulimab（HLX10, Anti-PD-1 Antibody） in Advanced NSCLC Patients With BRAF V600E Mutation.
An open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 （anti-PD-1 monoclonal antibody）in advanced NSCLC patients with BRAF V600 mutation.
Read the detailed description
This is an open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 （anti-PD-1 monoclonal antibody）in advanced NSCLC patients with BRAF V600 mutation.
For the phase Ib study, HLX208 is administered orally at two dose levels of 600mg BID or 900 mg BID. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
For the phase II study, HLX208 is administered orally with the RP2D dose. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
- Conditions
- Non Small Cell Lung Cancer
- Being tested
- HLX208+HLX10
- Keywords
- HLX208, HLX10, BRAF V600E mutation
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HLX208+HLX10Combination product
HLX208 is a BRAF V600E inhibitor ,and HLX10 is an anti-PD-1 monoclonal antibody.
| Study group | Role | What they receive |
|---|---|---|
| HLX208 combined HLX10 | Experimental | For the phase Ib study, HLX208 is administered orally at two dose levels of 600mg BID or 900 mg BID. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
For the phase II study, HLX208 is administered orally with the RP2D dose. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks. Receives: Combination Product: HLX208+HLX10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD (for phase Ib study)
The maximum tolerated dose of HLX208 combined with HLX10.
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
DLT (for phase Ib study)
The proportion of patients experiencing dose limiting toxicity (DLT) events.
Measured: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
ORR (for phase II study)
Objective response rate assessed by the investigator per RECIST 1.1.
Measured: up to approximately up to 24 months
Secondary outcomes (16)
PFS
Progression-Free-Survival
Measured: approximately up to 36 months
DCR
Disease-Control-Rate
Measured: approximately up to 24 months
DOR
Duration of Overall Response
Measured: approximately up to 24 months
TTR
Time to Tumor Response
Measured: approximately up to 24 months
12-month OS rate
12-month OS rate
Measured: 12 months
6-month OS rate
6-month OS rate
Measured: 6 months
OS
Overall-Survival
Measured: approximately up to 48 months
12-month PFS rate
12-month PFS rate
Measured: 12 months
6-month PFS rate
6-month PFS rate
Measured: 6 months
SAE
The proportion of patients experiencing SAE.
Measured: approximately up to 48 months
AUC0-T
Area under the concentration-time curve from time 0 to the last concentration measurable time point.
Measured: From First administration of HLX 208 to 12 weeks.
AUC0-∞
Area under the concentration-time curve from time 0 to infinity.
Measured: From First administration of HLX 208 to 12 weeks.
Cmax
Peak Plasma Concentration.
Measured: From First administration of HLX 208 to 12 weeks.
Tmax
Time to first occurrence of Cmax
Measured: From First administration of HLX 208 to 12 weeks.
t1/2
Elimination half-life
Measured: From First administration of HLX 208 to 12 weeks.
AUCss
Area under the steady-state concentration-time curve
Measured: From First administration of HLX 208 to 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start28 Feb 2023
- Primary completion4 Mar 2025 (estimated)
- Study completion27 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Henlius Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, Dr., Principal investigator, Shanghai Chest Hospital of Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641493
- Sponsor's protocol ID
- HLX208-NSCLC203
- Status last verified
- Apr 2023
- First submitted
- 15 Nov 2022
- Last updated
- 10 Apr 2023
- 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 10 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HLX208 （BRAF V600E Inhibitor） Combined With Serplulimab（HLX10, Anti-PD-1 Antibody） in Advanced NSCLC Patients With BRAF V600E Mutation.
- ClinicalTrials.gov ID
- NCT05641493
- Acronym / sponsor ID
- HLX208-NSCLC203
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- HLX208, HLX10, BRAF V600E mutation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (estimated)
- Lead sponsor
- Shanghai Henlius BiotechIndustry (pharma, biotech, devices)
- Study start
- 28 Feb 2023 (actual)
- Primary completion
- 4 Mar 2025 (estimated)
- Study completion
- 27 Feb 2026 (estimated)
- First posted
- 7 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.
An open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 （anti-PD-1 monoclonal antibody）in advanced NSCLC patients with BRAF V600 mutation.
Detailed description
This is an open-label, multicenter phase Ib/II clinical study to evaluate safety, tolerability, pharmacokinetics, and efficacy of HLX208 (BRAF V600E Inhibitor) combined with HLX10 （anti-PD-1 monoclonal antibody）in advanced NSCLC patients with BRAF V600 mutation.
For the phase Ib study, HLX208 is administered orally at two dose levels of 600mg BID or 900 mg BID. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
For the phase II study, HLX208 is administered orally with the RP2D dose. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HLX208 combined HLX10 | Experimental | Combination Product: HLX208+HLX10For the phase Ib study, HLX208 is administered orally at two dose levels of 600mg BID or 900 mg BID. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks. For the phase II study, HLX208 is administered orally with the RP2D dose. And HLX10 is administered intravenously at a fixed dose of 300mg every 3 weeks. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥18 and ≤75 years old of age (in phase Ib study) or ≥18 and ≤80 years old of ag (in phase II study) at the time of informed consent.
- Signed written informed consent.
- BRAF V600E mutant advanced solid tumors (in phase Ib study) or advanced NSCLC (in phase II study) patients with positive PD-L1 expression (TPS or TC≥1%).
- Previous failure of standard therapy, intolerance to standard therapy, lack of standard therapy, or currently unsuitable for standard therapy.
- Prior systemic anti-neoplastic therapy (chemotherapy, radiotherapy, targeted therapy, or traditional Chinese medicine with anti-neoplastic indications) must have been ≥ 2 weeks from the first dose in this study with treatment-related AE resolved to NCI-CTCAE Grade ≤ 1 (except for alopecia)
Key exclusion criteria (19 listed)
- For subjects in phase II study: previous treatment with BRAF inhibitors or MEK inhibitors or previous treatment with T cell co-stimulation or immune checkpoint therapy.
- Known EGFR mutations or ALK rearrangements (except in subjects with EGFR mutations whose disease has progressed after previous EGFR inhibitor treatment).
- Received strong CYP3A inhibitors or inducers treatment within 1 week prior to the first dose of investigational product.
- Received major surgery within 28 days prior to the first dose of investigational product. A major surgery is defined as a surgery that takes at least 3 weeks of postoperative recovery before receiving treatment in this study.
- With uncontrolled pleural effusion, pericardial effusion, or ascites.
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 |
|---|---|---|
| HLX208+HLX10HLX208 is a BRAF V600E inhibitor ,and HLX10 is an anti-PD-1 monoclonal antibody. | Combination product | HLX208 combined HLX10 |
Primary outcome
MTD (for phase Ib study)
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
The maximum tolerated dose of HLX208 combined with HLX10.
DLT (for phase Ib study)
Time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).
The proportion of patients experiencing dose limiting toxicity (DLT) events.
ORR (for phase II study)
Time frame: up to approximately up to 24 months
Objective response rate assessed by the investigator per RECIST 1.1.
16 secondary outcomes
PFS
Time frame: approximately up to 36 months
DCR
Time frame: approximately up to 24 months
DOR
Time frame: approximately up to 24 months
TTR
Time frame: approximately up to 24 months
12-month OS rate
Time frame: 12 months
6-month OS rate
Time frame: 6 months
OS
Time frame: approximately up to 48 months
12-month PFS rate
Time frame: 12 months
6-month PFS rate
Time frame: 6 months
SAE
Time frame: approximately up to 48 months
AUC0-T
Time frame: From First administration of HLX 208 to 12 weeks.
AUC0-∞
Time frame: From First administration of HLX 208 to 12 weeks.
Cmax
Time frame: From First administration of HLX 208 to 12 weeks.
Tmax
Time frame: From First administration of HLX 208 to 12 weeks.
t1/2
Time frame: From First administration of HLX 208 to 12 weeks.
AUCss
Time frame: From First administration of HLX 208 to 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2023.
- Individual participant dataSharing planned: No
Related trials for Non Small Cell Lung Cancer
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
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung 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.
Shun Lu, Dr. principal investigator
Shanghai Chest Hospital of Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HLX208+HLX10 in people with Non Small Cell Lung Cancer, 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 11 inclusion and 19 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 10 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 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 combined 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.
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 Shun Lu, Dr. (021-22200000, shunlu@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (for phase Ib study) (time frame: From first dose to the end of Cycle 1 (each cycle is 3 weeks).). 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?
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 10 Apr 2023.