Non-Small Cell Lung Cancer、EGFR Sensitive MutationPhase 1NCT06015568
Study of MCLA-129 Combined With Befotertinib in the Treatment of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation
A Phase 1 study testing MCLA-129: 1500mg or 2000mg IV Q2W and Befotertinib: 75 mg or 100 mg Po QD in people with Non-Small Cell Lung Cancer、EGFR Sensitive Mutation, run by Betta Pharmaceuticals Co., Ltd. at 3 sites in China.
Trial summary
To evaluate the safety and tolerance of MCLA-129 combined with Befotertinib in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-Small Cell Lung Cancer、EGFR Sensitive Mutation
- What is being tested?
- MCLA-129: 1500mg or 2000mg IV Q2W and Befotertinib: 75 mg or 100 mg Po QD
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 3 sitesChina
- Study dates
- 1 Sep 2023to 4 Jul 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Age from 18 to 75 years.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not suitable for radical surgery or radiotherapy, and harbored EGFR exon 19 deletion or exon 21 L858R mutation( either alone or in combination with other EGFR mutations) in NSCLC assessed by genetic testing.
- For Part 1: patients with advanced NSCLC must be progression, or intolerance, or rejected to standard therapy(subjects treated with Befotertinib must be progression of the disease).
- For Part 2, each cohort is defined as follows:
- Cohort A: Previously diagnosed EGFR-sensitive mutations and no systemic antitumor therapy for locally advanced or metastatic NSCLC.
- Cohort B: Advanced NSCLC patients with previously diagnosed EGFR-sensitive mutations and third generation EGFR-TKI resistance.
Show all 16Show fewer
- Cohort C: Advanced NSCLC patients who had previously been diagnosed with EGFR-sensitive mutations and first or second EGFR-TKI resistance.
- Patients in cohorts B and C must also resistance, or intolerance, or rejection of platinum-containing chemotherapy.
- •Patients of the dose escalation phase in Part 1 must have evaluable diseases, and others must have measurable diseases as defined in RECIST V1.1 definition.
- Note: The selected target lesions must meet one of two criteria: 1) no previous local treatment or 2) subsequent progression within the previous local treatment area as determined by RECIST V1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status scores are 0-1.
- Expected survival is ≥3 months.
- With certain organ system functions (without transfusion, use of blood components, or G-CSF support within 14 days before testing), as defined below:
- oAbsolute neutrophil count (ANC)≥1.5×10^9/L oPlatelet count (PLT)≥100×10^9/L oHemoglobin (HB)≥10 g/dL oSerum albumin≥30 g/L oTotal bilirubin≤1.5 times the upper limit of normal (ULN) oAlanine amino transferase ( ALT) and aspartate amino transferase (AST) ≤3×ULN oCreatinine≤1.5×ULN.If creatinine is>1.5×ULN, creatinine clearance is≥50 mL/min as calculated by Cockcroft-Gault formula, or urinary creatinine clearance≥50 mL/min within 24 hours as measured, the patients can still be enrolled.
- Willing and able to follow the trial and follow-up procedures.
- Capable of understanding the trial nature and voluntarily signing the written informed consent form.
Who cannot join
- Use of certain investigational drug or antineoplastic agent within 14 days or 5 half lives (whichever is longer) before first administration of investigational drug (For drugs with a longer half-life, a maximum of 4 weeks is required from the last administration; 6 weeks for chemotherapy with delayed toxicity, such as Nitroso urea or Mitomycin C).
- Execution of large surgery and radiotherapy (except focal palliative radiotherapy at least 2 weeks before first administration) within 4 weeks before first administration.
- For the dose extension stage of part 2 and part 2: having previously received systemic anti-tumor therapy exceeding three lines (excluding maintenance therapy).
- Previously received EGFR/c-Met bispecific antibody drugs (such as JNJ-61186372, EMB-01, or GB263T) for treatment.
- Prior to the first administration of the study drug, previous treatment-related toxic reactions did not alleviate to level 1 or below (CTCAE 5.0 standard), except for hair loss.
- With other malignant tumors in the past 3 years, except cancers that have been cured significantly or can be focally cured, e.g. basosquamous carcinoma of skin, carcinoma cervix in situ, or in situ breast carcinoma.
Show all 25Show fewer
- Primary malignant tumor of the central nervous system, meningeal metastasis, or brain metastasis with spinal cord compression, or risk of cerebral hemorrhage, or symptomatic brain metastasis, or unstable brain metastasis requiring steroid and/or dehydration to reduce intracranial pressure 2 weeks before enrollment (subjects with brain metastases who are Asymptomatic or stable for more than 2 weeks after treatment and do not need steroids and/or dehydration to reduce intracranial pressure can be included in the group).
- With clinically significant cardiovascular disorder, including but not limited to:
- Arterial thromboembolism, deep vein thrombosis or lung embolism diagnosed within 3 month before first administration of the investigational drug. Non- obstructive catheter related clot and other clinically irrelevant thrombosis are not included in the exclusion criteria. Patients with a history of related thrombosis diagnosed 3 months ago must be clinically stable for at least 4 weeks before initial administration.
- With any of the following medical history within 6 months before first administration of the investigational drug: myocardial infarction, unstable angina, stroke, transient ischemic attack, coronary or peripheral artery bypass, or any acute coronary syndrome.
- With abnormal ECG corrected QT interval (QTcF) at rest in the screening period. Remeasurement is made twice at intervals of more than 5 minutes. For average QTcF of 3 times ECG inspections: male: ≥ 450 msec, and female: ≥ 470 msec. With clinically significant abnormal heart rate, conduction, and ECG form at rest, e.g. complete left bundle branch block, third-degree conduction block, second-degree conduction block, and PR interval > 250 msec, double law, triple law, preexcitation syndrome, etc.
- Poorly controlled hypertension in the investigator's opinion (systolic blood pressure > 180 mmHg, or diastolic blood pressure > 100 mmHg).
- New York Heart Association Grade III-IV congestive heart failure, or hospitalization due to congestive heart failure within 6 months before first administration of the investigational drug.
- Pericarditis/clinically significant pericardial effusion.
- Cardiomyopathy.
- ther clinically significant cardiovascular disordesr as believed by investigators.
- Active hepatitis B (hepatitis B surface antigen (HBsAg) positive and serum HBV DNA quantitative results higher than or equal to the detection limit), hepatitis C virus antibody, HIV antibody and treponema pallidum antibody positive (subjects who have a history of HCV and have completed antiviral treatment, and whose laboratory test results show that HCV-RNA is below the lower limit of quantification, can be selected for the study; those who test negative for syphilis titer can be selected).
- Patients with Interstitial lung disease, including drug-induced Interstitial lung disease or radiation pneumonia requiring long-term use of steroids or other Immunosuppressive drug in the past 1 year.
- Subjects with active gastrointestinal (GI) disease, or with a risk of GI perforation, or with other diseases that significantly interfere with the absorption, distribution, metabolism, or excretion of investigational drugs. Including but not limited to: unable to take oral medicine, uncontrollable nausea or vomiting, Bowel obstruction, inflammatory bowel disease or extensive intestinal resection, etc.
- Current severe disease or medical condition, including but not limited to uncontrolled active infection, uncontrollable pleural or abdominal effusion, and clinically significant lung, metabolic or psychiatric disorders.
- Women with child bearing potential, pregnant women or lactating women with pregnancy test positive 7 days before treatment, and male and female unwilling to take effective contraception measures or having a birth plan during the treatment and within 3 months after end of treatment.
- Subjects with a history of allergies or suspected allergic symptoms to the study drug MCLA-129, Befotertinib, or any component of both study drugs (see the investigator's brochure).
- Within one week before the first administration of the investigational drug, it is currently in use or needs to be combined with CYP3A strong inhibitors or inducers during the study period.
- Subjects still using Warfarin within 7 days before the first administration (low molecular weight heparin sodium is allowed).
- Patients poorly compliant, unable or unwilling to follow the study and/or follow-up procedures listed in the protocol, or unsuitable to participate in this trial in the investigator's opinion.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites
The first affiliated hospital of bengbu medical college
Bengbu, Anhui
Wei Li, M.D., +86 13965282263, bbmcliwei@126.com
Yuanyuan Liu, Bachelor, +86 18955225050, 120952297@qq.com
Hunan cancer hospital
Changsha, Hunan
Lin Wu, M.D., +86 13170419973, wulin-calf@vip.163.com
Shanghai chest hospital
Shanghai
Shun Lu, M.D., 00-021-22200000-2153, Shun_lu@hotmail.com
About this study
Official title: Phase I Study of Anti-EGFR/c-Met Bispecific Antibody MCLA-129 Combined With Befotertinib in Patients of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation To Evaluate The Safety, Pharmacokinetic Characteristics and Antitumor Activity
To evaluate the safety and tolerance of MCLA-129 combined with Befotertinib in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations.
Read the detailed description
This is a phase I study to evaluate the safety, pharmacokinetic characteristics and antitumor activity of anti-EGFR/c-Met bispecific antibody MCLA-129(1500mg Q2W IV or 2000mg Q2W IV) combined with Befotertinib (75 mg once daily for first cycle, then increased to 100 mg once daily, orally) in Patients of advanced non-small cell lung cancer with exon 19 deletion or exon 21 L858R mutation(either alone or in combination with other EGFR mutations).
- Being tested
- MCLA-129: 1500mg or 2000mg IV Q2W, Befotertinib: 75 mg or 100 mg Po QD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCLA-129: 1500mg or 2000mg IV Q2WDrug
Every 28 days is a cycle until disease progression, death, initiation of new anti-tumor treatment, loss of follow-up, or voluntary withdrawal occurs
Befotertinib: 75 mg or 100 mg Po QDDrug
The initial dose of Befotertinib is 75 mg orally once daily (QD) for one cycle, and then increased to 100 mg orally QD in the absence of CTCAE grade ≥ 2 headache or thrombocytopenia during the first cycle, otherwise maintained to 75 mg orally QD.
Every 28 days is a cycle until disease progression, death, initiation of new anti-tumor treatment, loss of follow-up, or voluntary withdrawal occurs.
| Study group | Role | What they receive |
|---|---|---|
| MCLA-129+ Befotertinib | Experimental | Drug:MCLA-129 1500mg or 2000mg IV Q2W Other name:MCLA-129 Drug:Befotertinib (75 mg or 100 mg orally, once daily) Other name:D-0316 Receives: Drug: MCLA-129: 1500mg or 2000mg IV Q2W; Drug: Befotertinib: 75 mg or 100 mg Po QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity (DLT)
To determine the dose-limiting toxicity (DLT) of MCLA-129 combined with Befotertinib in patients of advanced non-small cell lung cancer with EGFR-sensitive mutations in Part 1.
Measured: First 28 days of treatment
Maximum Tolerable Dose (MTD)
To determine the maximum tolerated dose (MTD) of MCLA-129 combined with Befotertinib in patients of advanced non-small cell lung cancer with EGFR-sensitive mutations in Part 1.
Measured: First 28 days of treatment
Treatment-Emergent Adverse Event (TEAE) in Part 1
To evaluate the safety of MCLA-129 combined with Befotertinib in patients of advanced non-small cell lung cancer with EGFR-sensitive mutations in Part 1 in terms of treatment-emergent adverse event (TEAE).
Measured: Until 30 days after the last dosing
Overall Response Rate (ORR) in Part 2
To evaluate the efficacy of MCLA-129 combined with Befotertinib at RP2CD in patients of advanced NSCLC with EGFR-sensitive mutations in each corhort in Part 2 in terms of overall response rate (ORR)
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Secondary outcomes (11)
Overall Response Rate (ORR) in Part 1
To evaluate the efficacy of MCLA-129 combined with Befotertinib at RP2CD in patients of advanced NSCLC with EGFR-sensitive mutations in each corhort in Part 1 in terms of overall response rate (ORR).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Disease Control Rate (DCR) in Part 1 and 2
To evaluate the efficacy of MCLA-129 combined with Befotertinib at RP2CD in patients of advanced NSCLC with EGFR-sensitive mutations in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of disease control rate (DCR).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Progression-Free Survival (PFS) in Part 1 and 2
To evaluate the efficacy of MCLA-129 combined with Befotertinib at RP2CD in patients of advanced NSCLC with EGFR-sensitive mutations in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of Progression-free survival (PFS).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Duration of Response (DOR) in Part 1 and 2
To evaluate the efficacy of MCLA-129 combined with Befotertinib at RP2CD in patients of advanced NSCLC with EGFR-sensitive mutations in patients with advanced NSCLC and other solid tumors in Part 1 and 2 in terms of duration of response (DOR).
Measured: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Anti-Drug Antibody (ADA) in Part 1 and 2
To assess the Incidence of anti-drug antibodies in serum blood against MCLA-129 following administration of MCLA-129.
Measured: Until 30 days after the last dosing
Overall Survival (OS) in Part 2
To evaluate the efficacy of MCLA-129 combined with Befotertinib at RP2CD in patients of advanced NSCLC with EGFR-sensitive mutations in Part 2 in terms of overall survival (OS).
Measured: From date of first treatment every 6 weeks until death or withdrawal, whichever came first, approximately 2 years
Treatment-Emergent Adverse Event (TEAE) in and 2
To evaluate the safety of MCLA-129 combined with Befotertinib in patients of advanced non-small cell lung cancer with EGFR-sensitive mutations in Part 2 in terms of treatment-emergent adverse event (TEAE).
Measured: Until 30 days after the last dosing
Maximum plasma concentration [Cmax]
To evaluate the PK profile of MCLA-129 combined with Befotertinib in patients dvanced NSCLC with EGFR-sensitive mutations in Part 1.
Measured: Until 30 days after the last dosing
Time to reach maximum concentration [Tmax]
To evaluate the PK profile of MCLA-129 combined with Befotertinib in patients dvanced NSCLC with EGFR-sensitive mutations in Part 1.
Measured: Until 30 days after the last dosing
Trough concentration [Ctrough]
To evaluate the PK profile of MCLA-129 combined with Befotertinib in patients dvanced NSCLC with EGFR-sensitive mutations in Part 1.
Measured: Until 30 days after the last dosing
Area under the concentration [AUC]
To evaluate the PK profile of MCLA-129 combined with Befotertinib in patients dvanced NSCLC with EGFR-sensitive mutations in Part 1.
Measured: Until 30 days after the last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2023
- Study start1 Sep 2023 (estimated)
- Primary completion4 Nov 2028 (estimated)
- Study completion4 Jul 2029 (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 Cancer、EGFR Sensitive MutationStudies of the same condition, open and under way.
- More trials run by Betta Pharmaceuticals 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
- 172 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shun Lu, M.D., Study chair, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06015568
- Sponsor's protocol ID
- BTP-21712
- Status last verified
- Aug 2023
- First submitted
- 21 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Anti-EGFR/c-Met Bispecific Antibody MCLA-129 Combined With Befotertinib in Patients of Advanced Non-small Cell Lung Cancer With EGFR Sensitive Mutation To Evaluate The Safety, Pharmacokinetic Characteristics and Antitumor Activity
- ClinicalTrials.gov ID
- NCT06015568
- Acronym / sponsor ID
- BTP-21712
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 172 participants (estimated)
- Lead sponsor
- Betta Pharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 4 Nov 2028 (estimated)
- Study completion
- 4 Jul 2029 (estimated)
- First posted
- 29 Aug 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.
To evaluate the safety and tolerance of MCLA-129 combined with Befotertinib in patients with advanced non-small cell lung cancer with EGFR-sensitive mutations.
Detailed description
This is a phase I study to evaluate the safety, pharmacokinetic characteristics and antitumor activity of anti-EGFR/c-Met bispecific antibody MCLA-129(1500mg Q2W IV or 2000mg Q2W IV) combined with Befotertinib (75 mg once daily for first cycle, then increased to 100 mg once daily, orally) in Patients of advanced non-small cell lung cancer with exon 19 deletion or exon 21 L858R mutation(either alone or in combination with other EGFR mutations).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MCLA-129+ Befotertinib | Experimental | Drug: MCLA-129: 1500mg or 2000mg IV Q2W, Drug: Befotertinib: 75 mg or 100 mg Po QDDrug:MCLA-129 1500mg or 2000mg IV Q2W Other name:MCLA-129 Drug:Befotertinib (75 mg or 100 mg orally, once daily) Other name:D-0316 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age from 18 to 75 years.
- Histologically or cytologically confirmed locally advanced or metastatic NSCLC that is not suitable for radical surgery or radiotherapy, and harbored EGFR exon 19 deletion or exon 21 L858R mutation( either alone or in combination with other EGFR mutations) in NSCLC assessed by genetic testing.
- For Part 1: patients with advanced NSCLC must be progression, or intolerance, or rejected to standard therapy(subjects treated with Befotertinib must be progression of the disease).
- For Part 2, each cohort is defined as follows:
- Patients in cohorts B and C must also resistance, or intolerance, or rejection of platinum-containing chemotherapy.
Key exclusion criteria (25 listed)
- Use of certain investigational drug or antineoplastic agent within 14 days or 5 half lives (whichever is longer) before first administration of investigational drug (For drugs with a longer half-life, a maximum of 4 weeks is required from the last administration; 6 weeks for chemotherapy with delayed toxicity, such as Nitroso urea or Mitomycin C).
- Execution of large surgery and radiotherapy (except focal palliative radiotherapy at least 2 weeks before first administration) within 4 weeks before first administration.
- For the dose extension stage of part 2 and part 2: having previously received systemic anti-tumor therapy exceeding three lines (excluding maintenance therapy).
- Previously received EGFR/c-Met bispecific antibody drugs (such as JNJ-61186372, EMB-01, or GB263T) for treatment.
- Prior to the first administration of the study drug, previous treatment-related toxic reactions did not alleviate to level 1 or below (CTCAE 5.0 standard), except for hair loss.
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 |
|---|---|---|
| MCLA-129: 1500mg or 2000mg IV Q2WEvery 28 days is a cycle until disease progression, death, initiation of new anti-tumor treatment, loss of follow-up, or voluntary withdrawal occurs | Drug | MCLA-129+ Befotertinib |
| Befotertinib: 75 mg or 100 mg Po QDThe initial dose of Befotertinib is 75 mg orally once daily (QD) for one cycle, and then increased to 100 mg orally QD in the absence of CTCAE grade ≥ 2 headache or thrombocytopenia during the first cycle, otherwise maintained to 75 mg orally QD. Every 28 days is a cycle until disease progression, death, initiation of new anti-tumor treatment, loss of follow-up, or voluntary withdrawal occurs. | Drug | MCLA-129+ Befotertinib |
Primary outcome
Dose-Limiting Toxicity (DLT)
Time frame: First 28 days of treatment
To determine the dose-limiting toxicity (DLT) of MCLA-129 combined with Befotertinib in patients of advanced non-small cell lung cancer with EGFR-sensitive mutations in Part 1.
Maximum Tolerable Dose (MTD)
Time frame: First 28 days of treatment
To determine the maximum tolerated dose (MTD) of MCLA-129 combined with Befotertinib in patients of advanced non-small cell lung cancer with EGFR-sensitive mutations in Part 1.
Treatment-Emergent Adverse Event (TEAE) in Part 1
Time frame: Until 30 days after the last dosing
To evaluate the safety of MCLA-129 combined with Befotertinib in patients of advanced non-small cell lung cancer with EGFR-sensitive mutations in Part 1 in terms of treatment-emergent adverse event (TEAE).
Overall Response Rate (ORR) in Part 2
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
To evaluate the efficacy of MCLA-129 combined with Befotertinib at RP2CD in patients of advanced NSCLC with EGFR-sensitive mutations in each corhort in Part 2 in terms of overall response rate (ORR)
11 secondary outcomes
Overall Response Rate (ORR) in Part 1
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Disease Control Rate (DCR) in Part 1 and 2
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Progression-Free Survival (PFS) in Part 1 and 2
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Duration of Response (DOR) in Part 1 and 2
Time frame: From date of first treatment every 6 weeks until disease progression, death or withdrawal, whichever came first, approximately 2 years
Anti-Drug Antibody (ADA) in Part 1 and 2
Time frame: Until 30 days after the last dosing
Overall Survival (OS) in Part 2
Time frame: From date of first treatment every 6 weeks until death or withdrawal, whichever came first, approximately 2 years
Treatment-Emergent Adverse Event (TEAE) in and 2
Time frame: Until 30 days after the last dosing
Maximum plasma concentration [Cmax]
Time frame: Until 30 days after the last dosing
Time to reach maximum concentration [Tmax]
Time frame: Until 30 days after the last dosing
Trough concentration [Ctrough]
Time frame: Until 30 days after the last dosing
Area under the concentration [AUC]
Time frame: Until 30 days after the last dosing
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Non-Small Cell Lung Cancer、EGFR Sensitive Mutation
RecruitingPhase 1/2
Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
High Grade Epithelial Ovarian Cancer, High Grade Serous Ovarian Cancer
RecruitingPhase 2
Befotertinib Plus Chemotherapy With an MRD-guided Adaptive Strategy for Treatment Escalation and Response Optimization in EGFR-mutated NSCLC Patients
Advanced Non-small Cell Lung Cancer (NSCLC), EGFR Exon 19 Deletion Mutation
Not yet recruitingPhase 4
A Clinical Study Comparing the Efficacy and Safety of Befotertinib Versus Icotinib in Patients With Previously Untreated EGFR-sensitive Mutation-positive Non-small Cell Lung Cancer With ECOG Score ≥2
Locally Advanced or Metastatic Non-small Cell Lung Cancer With Previously Untreated EGFR-sensitive Mutations and ECOG Performance Status Score ≥2
RecruitingObservational study
Real World Study of Icotinib in Adjuvant Post Surgical Treatment for Stage IA2 High Risk to IB EGFR Mutant Non Small Cell Lung Cancer
NSCLC (Non-small Cell Lung Cancer)
Not yet recruitingObservational study
In Vitro NSCLC EGFR-Mutant Models for Drug Sensitivity Testing
Carcinoma, Non-Small-Cell Lung, EGFR Gene Mutation
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.
Shun Lu, M.D. study chair
Shanghai Chest Hospital
3 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 MCLA-129: 1500mg or 2000mg IV Q2W and Befotertinib: 75 mg or 100 mg Po QD in people with Non-Small Cell Lung Cancer、EGFR Sensitive Mutation, run by Betta Pharmaceuticals Co., Ltd. at 3 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 16 inclusion and 25 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: opening soon, as of the sponsor's last update on 29 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 3 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dandan Zhang, Master (+86 18626898205, dandan.zhang@bettapharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity (DLT) (time frame: First 28 days of treatment). The study lists 4 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 29 Aug 2023.