Locally Advanced or Metastatic Non-Small Cell Lung CancerPhase 1NCT04448379
Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Non-Small Cell Lung Cancer
A Phase 1 study testing JMT101 in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by Shanghai JMT-Bio Inc. at 13 sites in China.
Trial summary
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- What is being tested?
- JMT101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 13 sitesChina
- Study dates
- 29 Jun 2020to 30 Jun 2022
- 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
- Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
- No previous treatment or first-line treatment failed NSCLC;
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG score 0 or 1;
Who cannot join
- Previously treated with EGFR antibody;
- Symptomatic brain metastasis;
- Interstitial pneumopathy;
- Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
- Receiving an investigational product in another clinical study within 4 weeks;
- History of serious systemic diseases;
- History of serious autoimmune diseases;
- Pregnancy or lactating women.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
Chinese Pla General Hospital
Beijing
Yi Hu
- Recruiting
Hunan Cancer Hospital
Changsha
Lin Wu
- Recruiting
West China Hospital of Sichuan University
Chengdu
Feng Luo
- Recruiting
Fujian Cancer Hospital
Fuzhou
Wu Zhuang
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Li Zhang, 8020-87343458, zhangli@sysucc.org.cn
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
Yiping Zhang
- Recruiting
Jiangsu Province Hospital of Chinese Medicine
Nanjing
Qian Wang
- Recruiting
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing
Liyun Miao
- Recruiting
Shanghai Chest Hospital, Shanghai Jiaotong University
Shanghai
Baohui Han
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000
Da Jiang, 80311-86095588, jiangda139@163.com
Mingxia Wang, 80311-66696233, hb4thgcp@126.com
- Recruiting
Shanxi Bethune Hospital (Shanxi Academy of Medical Sciences)
Taiyuan
Junping Zhang
- Recruiting
Shanxi Province Cancer Hospital
Taiyuan
Wei Guo
- Recruiting
Union Hospital, affiliated with TongJi Medical College, HuaZhong University of Science and Technology
Wuhan
Xiaorong Dong
About this study
Official title: A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
This study is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Read the detailed description
The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.
- Being tested
- JMT101
- 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.
JMT101Drug
Also called Afatinib or Osimertinib
IV infusion Q2W for 4 weeks (28-day cycles)
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Cohort | Experimental | Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design.
The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days). Receives: Drug: JMT101 |
| Dose Expansion Cohort | Experimental | Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. Receives: Drug: JMT101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
Measured: From enrollment until 30 days after the last dose
Secondary outcomes (10)
Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Measured: From first dose to disease progression or end of study, an average of 1 year
Disease control rate (DCR).
Measured: From first dose to disease progression or end of study, an average of 1 year
Progression free survival (PFS).
Measured: From first dose to disease progression or end of study, an average of 1 year
Overall survival (OS).
Measured: From first dose to death or end of study, an average of 1 year
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Measured: From enrollment until 30 days after the last dose
Maximum measured plasma concentration (Cmax) of JMT101.
Measured: From enrollment until 30 days after the last dose
Time to maximum plasma concentration (Tmax) of JMT101.
Measured: From enrollment until 30 days after the last dose
Half-life (T1/2) of JMT101.
Measured: From enrollment until 30 days after the last dose
Immunogenicity profile of JMT101.
Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.
Measured: From enrollment until 30 days after the last dose
Potential biomarkers detected in plasma circulating tumor DNA.
Measured: From enrollment up to disease progression, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start29 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced or Metastatic Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448379
- Sponsor's protocol ID
- JMT101-CSP-001
- Status last verified
- Jul 2020
- First submitted
- 16 Jun 2020
- Last updated
- 28 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zhao S, Zhuang W, Han B, Song Z, Guo W, Luo F, Wu L, Hu Y, Wang H, Dong X, Jiang D, Wang M, Miao L, Wang Q, Zhang J, Fu Z, Huang Y, Xu C, Hu L, Li L, Hu R, Yang Y, Li M, Yang X, Zhang L, Huang Y, Fang W. Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer. Nat Commun. 2023 Jun 12;14(1):3468. doi: 10.1038/s41467-023-39139-4.
PubMed 37308490
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib,Open Label,Multi-center Study to Assess the Efficacy and Safety of JMT101 Combined With Afatinib (or Osimertinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With EGFR Exon 20 Insertion Mutations
- ClinicalTrials.gov ID
- NCT04448379
- Acronym / sponsor ID
- JMT101-CSP-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
- Study start
- 29 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 25 Jun 2020 (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 is a Phase Ib, open label, multi-center study of to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (Afatinib or Osimertinib) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations.
Detailed description
The objective of the trial is to evaluate the safety and efficacy of JMT101 combined with EGFR-TKIs (afatinib or osimertinib) in patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations.
This study consists of two parts (Stage I and Stage II). Stage I was a dose escalation study, and Stage II was a dose expansion study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Cohort | Experimental | Drug: JMT101Two dose levels of JMT101 combined with afatinib or osimertinib will be tested according to the "3 + 3" dose-escalation design. The dose-limiting toxicity (DLT) will be assessed from the first administration to the end of the first cycle (28 days). |
| Dose Expansion Cohort | Experimental | Drug: JMT101Once the effective dose has been determined, an expansion cohort will be opened to evaluate the efficacy and safety of the selected dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Pathologically or cytologically confirmed, locally advanced or metastatic NSCLC, harboring an EGFR exon 20 insertion mutation. ( non-irradiable, non-operable);
- No previous treatment or first-line treatment failed NSCLC;
- At least 1 measurable lesion according to RECIST 1.1;
- ECOG score 0 or 1;
Key exclusion criteria (8 listed)
- Previously treated with EGFR antibody;
- Symptomatic brain metastasis;
- Interstitial pneumopathy;
- Known hypersensitivity to any ingredient of JMT101, afatinib, osimertinib or their excipients;
- Receiving an investigational product in another clinical study within 4 weeks;
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 |
|---|---|---|
| JMT101Also: Afatinib or OsimertinibIV infusion Q2W for 4 weeks (28-day cycles) | Drug | Dose Escalation Cohort, Dose Expansion Cohort |
Primary outcome
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)).
Time frame: From enrollment until 30 days after the last dose
10 secondary outcomes
Objective Response Rate (ORR) Assessed by Blinded Independent Review Committee (IRC) per RECIST Version 1.1
Time frame: From first dose to disease progression or end of study, an average of 1 year
Disease control rate (DCR).
Time frame: From first dose to disease progression or end of study, an average of 1 year
Progression free survival (PFS).
Time frame: From first dose to disease progression or end of study, an average of 1 year
Overall survival (OS).
Time frame: From first dose to death or end of study, an average of 1 year
Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Maximum measured plasma concentration (Cmax) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Time to maximum plasma concentration (Tmax) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Half-life (T1/2) of JMT101.
Time frame: From enrollment until 30 days after the last dose
Immunogenicity profile of JMT101.
Time frame: From enrollment until 30 days after the last dose
Potential biomarkers detected in plasma circulating tumor DNA.
Time frame: From enrollment up to disease progression, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2020.
- Derived from this study: PubMed 37308490Zhao S, Zhuang W, Han B, Song Z, Guo W, Luo F, Wu L, Hu Y, Wang H, Dong X, Jiang D, Wang M, Miao L, Wang Q, Zhang J, Fu Z, Huang Y, Xu C, Hu L, Li L, Hu R, Yang Y, Li M, Yang X, Zhang L, Huang Y, Fang W. Phase 1b trial of anti-EGFR antibody JMT101 and Osimertinib in EGFR exon 20 insertion-positive non-small-cell lung cancer. Nat Commun. 2023 Jun 12;14(1):3468. doi: 10.1038/s41467-023-39139-4.
Related trials for Locally Advanced or Metastatic 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
RecruitingPhase 3
Study of Daraxonrasib (RMC-6236) in Patients With RAS Mutated NSCLC (RASolve 301)
NSCLC (Non-small Cell Lung Cancer), Non-Small Cell Lung Cancer
Not yet recruitingPhase 2
Phase II Study to Evaluate Telisotuzumab Adizutecan in Combination With RC148(ABBV-1480) as First-Line Treatment for Patients With Non-Squamous Non-Small-Cell Lung Cancer
Patients With Locally Advanced or Metastatic Non-Squamous NSCLC Requiring First-Line Treatment and no Driver Gene Alterations Confirmed by Histology or Cytology
RecruitingPhase 3
A Study to Learn More About How Well Sevabertinib Works and How Safe it is Compared With Standard Treatment, in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
Advanced Non-small Cell Lung Cancer, HER2 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
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.
13 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 JMT101 in people with Locally Advanced or Metastatic Non-Small Cell Lung Cancer, run by Shanghai JMT-Bio Inc. at 13 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 4 inclusion and 8 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 28 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiugao Yang (8021-60677906, yangxiugao@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events (defined by the Common Terminology Criteria for Adverse Events version 5.0 (CTCAE V5.0)). (time frame: From enrollment until 30 days after the last dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04448379, which also lists 1 linked publication.
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 28 Dec 2020.