Non-small Cell Lung CancerPhase 1TMT101-01NCT06861543

The Purpose of This Study is to Evaluate the Safety, Tolerability and Efficacy of TMT101 Injection Monotherapy in Patients With Advanced Pancreatic Cancer or Non-small Cell Lung Cancer(NSCLC)

A Phase 1 study testing TMT101 Injection in people with Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-small Cell Lung Cancer
What is being tested?: TMT101 Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteChina
Study dates: 1 Mar 2025to 1 Jul 2026
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Agrees to follow the trial protocol and visit schedule, has signed informed consent;
Subjects must be ≥18 years of age at time of informed consent,regardless of gender;
Patients with advanced/unresectable or metastatic pancreatic cancer or non-small cell lung cancer that requires histologically and/or cytologically confirmed according to the American Joint Committee on Cancer 8th edition; pancreatic cancer:Previous failure or intolerance of two or more lines of chemotherapy; NSCLC:Previous failure or intolerance of platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibodies, regardless of combination therapy or sequential therapy, if the previous test for EGFR-sensitive mutations or ALK fusion genes is positive, treatment with a third-generation TKI must be failed or intolerant;
At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
ECOG≤1;
Estimated life expectancy≥12 weeks;

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Adequate organ function, meet the following laboratory standards:
ANC≥1.5×109/L;PLT≥90×109/L;
Hb≥90 g/L;
TBIL≤1.5×ULN, Patients with Gilbert's syndrome ; without liver metastases, AST and ALT ≤ 2.5×ULN;liver metastases, AST and ALT ≤5×ULN ;
Ccr≥50 mL/min;
INR≤1.5×ULN, APTT≤1.5×ULN;
Males of childbearing potential and females of childbearing potential who are willing to use effective contraception since signing the informed consent until 6 months after the last dose of the trial drug. Females of childbearing potential must have a negative pregnancy test result within 7 days prior to the first dose.

Who cannot join

Allergic to TMT101 Injection or any of the components in the prescription;
Uncontrolled illness including, but not limited to, active infection requiring systemic therapy, uncontrolled hypertensionuncontrolled hyperglycemia, decompensated congestive heart failure , unstable angina, arrhythmias that require clinical intervention; ascites or uncontrolled pleural effusion (CTCAE 5.0≥grade 2), thrombosis (such as pulmonary embolism, cerebral infarction, myocardial infarction) or history of stroke, active autoimmune disease, psychiatric disease, active peptic ulcer disease, active bleeding disorder, which would limit compliance with study requirements or impair the patient's ability to sign informed consent in writing;
Patients who used immunosuppressive drugs within 3 weeks prior to the first dose, or patients who have achieved immunosuppressive intent (dose > 10 mg/day prednisone or other equivalent hormones and the duration of use is at least 7 days ) on systemic hormonal therapy or absorbable topical hormonal therapy, with the exception of physiologic doses of intranasal and inhaled corticosteroids;
Within 4 weeks prior to the first administration, received major surgery, radiotherapy (except palliative radiotherapy for bone metastasis), or treatment for surgical wounds that were not healed, ulcerated, or fractured; within 4 weeks prior to the first administration or within 5 half-lives (whichever is shorter) received anti-tumor treatments such as chemotherapy, biological therapy, endocrine therapy, targeted therapy, or immunotherapy.
Patients with prior or concurrent occurrence of other malignancies, with the following exceptions: a) Carcinoma in situ of the cervix or breast, curatively treated with no signs of recurrence for at least 3 years prior to the study; b) The primary malignancy was completely resected and in complete remission for ≥ 5 years;
History of interstitial lung disease or current interstitial lung disease or suspected of such disease by imaging during screening. and pneumonitis that previously required systemic corticosteroid treatment;

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Treponema pallidum antibody or human immunodeficiency virus (HIV) antibody positive, positive for hepatitis C virus antibody and hepatitis C virus (HCV) RNA, or active hepatitis B (positive for hepatitis B surface antigen and HBV DNA ≥ upper limit of normal);
Received live vaccines within 4 weeks before the first dose or planned to receive live vaccines during the study period and within 4 weeks after the last dose, including but not limited to: measles, mumps, rubella, chickenpox, yellow fever, rabies, BCG and typhoid vaccines;
History of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
Interventional therapy in other clinical trials 3 weeks before the first dose, and it is judged by the investigator and medical monitor to be unsuitable for inclusion in the study;
Patients who have had a previous ≥grade 3 immune-related adverse event or immunotherapy-related serious adverse event (SAE) leading to permanent discontinuation;
Pregnant or lactating females;
In the opinion of the investigator, the subject has other conditions that may affect compliance or are not suitable for participation in this study;
Patient has active central nervous system metastases (with or without treatment), including symptomatic brain metastases or meningeal metastases or spinal cord compression, but asymptomatic brain metastases except;
Within 4 weeks prior to the first dose, all toxicities from prior antineoplastic therapy have not recovered to grade 1 or less, with the following exceptions: a. alopecia, b. long-term toxicity caused by radiotherapy, c. other toxicities that cannot be recovered in the judgment of the investigator but have no effect on the subject's administration
Major surgery within 4 weeks prior to the first dose;
Transsplenectomy which is not suitable is judged by the investigator.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenming Wu, PhD contact

010-69156874 ext. 010-69155709

pumchkyc@126.com

China1 site, 1 recruiting

Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Wenming Wu, PhD, 010-69156874 ext. 010-69155709
Recruiting

Other trials in China

About this study

Official title: A Single Arm, Open Label, Dose-escalating, Prospective Phase I Clinical Trial Evaluating the Safety, Tolerability and Efficacy of TMT101 Injection Alone in Patients With Advanced Pancreatic Cancer or Non-small Cell Lung Cancer(NSCLC) After Standard Treatment Failure

This is a first-in-human, single-arm, open-label, dose escalation prospective phase I clinical study to evaluate the Safety, Tolerability and Efficacy of TMT101 Injection Alone in patients with Unresectable, Metastatic or Advanced pancreatic cancer or Non-small Cell Lung Cancer(NSCLC) after Standard Treatment Failure. The primary objective is to evaluate the safety and tolerability of TMT101 Injection as monotherapy in patients with advanced pancreatic cancer and NSCLC, and to determine the recommended therapeutic dose (RD) of TMT101 Injection as monotherapy

Read the detailed description

The dose escalation trial adopts the "3+3" design , and about 3~6 patients with advanced pancreatic cancer or non-small cell lung cancer are enrolled in each dose level to evaluate the safety of TMT101 Injection alone. Three dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. Once a week, intramuscular Injection , a total of 9 times (the first tumor assessment is performed in the 6th week (±7 days), the investigator can decide the follow-up medication arrangement according to the tumor evaluation results). Dose-limiting toxicities (DLTs) will be assessed for each dose level, and the DLT observation period will be within 21 days from the first dose. The initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. If the highest dose level of 0.4 mg is not confirmed as a possible recommended therapeutic dose (RD), it may be escalated a higher dose to determine the possible RD under the condition that investigator and the sponsor to decide together

Conditions: Non-small Cell Lung Cancer
Being tested: TMT101 Injection
Keywords: TMT101 Injection, mRNA, advanced pancreatic cancer or NSCLC
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.

TMT101 InjectionBiological
Three dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. The initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. TMT101 will be injected intramuscularly, Once a week,a total of 9 times

Study groups in NCT06861543
Study group	Role	What they receive
TMT101 Injection monotherapy	Experimental	Three dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. The initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. TMT101 will be injected intramuscularly, Once a week,a total of 9 times Receives: Biological: TMT101 Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

dose-limiting toxicities (DLTs)
Occurrence of dose-limiting toxicities (DLTs) within 21 days since the first dose
Measured: within 21 days since the first dose
treatment-emergent adverse events (TEAEs)
occurrence of treatment-emergent adverse events (TEAEs) and grade according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: up to 2 years
treatment related adverse event (TRAE)
Occurrence and grade of treatment related adverse event (TRAE) according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: up to 2 years
immune-related Adverse Event(irAE）
Occurrence and grade of immune-related Adverse Event(irAE）according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: up to 2 years
Serious Adverse Event(SAE）
Occurrence and grade of Serious Adverse Event(SAE）according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Measured: up to 2 years
Recommended Dose（RD）
During the dose escalation phase, the MTD and/or available safety, biomarker, and efficacy data will be evaluated thoroughly to determine the RD of TMT101 Injection alone . Three dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. Once the initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. If the highest dose level of 0.4 mg is not confirmed as a possible recommended therapeutic dose (RD), it may be escalated to a higher dose to determine the possible RD under the condition that investigator and the sponsor to decide together.
Measured: the whole escalation phase within 21 days since the first dose

Secondary outcomes (7)

Objective response rate (ORR)
the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and iRECIST
Measured: up to 2 years
Disease control rate (DCR)
the percentage of patients with CR or PR or stable disease (SD) as BOR according to RECIST v1.1 and iRECIST divided by the number of patients in the efficacy analysis set
Measured: up to 2 years
Progression-free survival (PFS)
the time of first trial treatment until the first objective tumor progression according to RECIST v1.1 and iRECIST or death from any cause, whichever occurs first
Measured: up to 2 years
Overall survival (OS)
the time of first trial treatment until death from any cause
Measured: up to 2 years
Peak time (Tmax) of cationic lipids
Measured: up to 9 weeks
Peak concentration (Cmax) of cationic lipids
Measured: up to 9 weeks
Area under the drug concentration -time curve (AUC) of cationic lipids
Measured: up to 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 20251 Jul 2026

First posted6 Mar 2025
Study start1 Mar 2025
Primary completion1 Dec 2025 (estimated)
Study completion1 Jul 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 Peking Union Medical College HospitalThe 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
Model description: TMT101 Injection alone
Masking: None (open label)
Enrolment: 18 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06861543
Sponsor's protocol ID: TMT101-01
Acronym: TMT101-01
Status last verified: Feb 2025
First submitted: 8 Feb 2025
Last updated: 11 Aug 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm, Open Label, Dose-escalating, Prospective Phase I Clinical Trial Evaluating the Safety, Tolerability and Efficacy of TMT101 Injection Alone in Patients With Advanced Pancreatic Cancer or Non-small Cell Lung Cancer(NSCLC) After Standard Treatment Failure
ClinicalTrials.gov ID: NCT06861543
Acronym / sponsor ID: TMT101-01 / TMT101-01
Conditions: Non-small Cell Lung Cancer
Keywords: TMT101 Injection, mRNA, advanced pancreatic cancer or NSCLC
Phase: Phase 1
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 18 participants (estimated)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Study start: 1 Mar 2025 (actual)
Primary completion: 1 Dec 2025 (estimated)
Study completion: 1 Jul 2026 (estimated)
First posted: 6 Mar 2025 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: TMT101 Injection alone

Arm	Type	Receives
TMT101 Injection monotherapy	Experimental	Biological: TMT101 InjectionThree dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. The initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. TMT101 will be injected intramuscularly, Once a week,a total of 9 times

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Agrees to follow the trial protocol and visit schedule, has signed informed consent;
Subjects must be ≥18 years of age at time of informed consent,regardless of gender;
Patients with advanced/unresectable or metastatic pancreatic cancer or non-small cell lung cancer that requires histologically and/or cytologically confirmed according to the American Joint Committee on Cancer 8th edition; pancreatic cancer:Previous failure or intolerance of two or more lines of chemotherapy; NSCLC:Previous failure or intolerance of platinum-containing chemotherapy and anti-PD-1/PD-L1 monoclonal antibodies, regardless of combination therapy or sequential therapy, if the previous test for EGFR-sensitive mutations or ALK fusion genes is positive, treatment with a third-generation TKI must be failed or intolerant;
At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1;
ECOG≤1;

Key exclusion criteria (17 listed)

Allergic to TMT101 Injection or any of the components in the prescription;
Uncontrolled illness including, but not limited to, active infection requiring systemic therapy, uncontrolled hypertensionuncontrolled hyperglycemia, decompensated congestive heart failure , unstable angina, arrhythmias that require clinical intervention; ascites or uncontrolled pleural effusion (CTCAE 5.0≥grade 2), thrombosis (such as pulmonary embolism, cerebral infarction, myocardial infarction) or history of stroke, active autoimmune disease, psychiatric disease, active peptic ulcer disease, active bleeding disorder, which would limit compliance with study requirements or impair the patient's ability to sign informed consent in writing;
Patients who used immunosuppressive drugs within 3 weeks prior to the first dose, or patients who have achieved immunosuppressive intent (dose > 10 mg/day prednisone or other equivalent hormones and the duration of use is at least 7 days ) on systemic hormonal therapy or absorbable topical hormonal therapy, with the exception of physiologic doses of intranasal and inhaled corticosteroids;
Within 4 weeks prior to the first administration, received major surgery, radiotherapy (except palliative radiotherapy for bone metastasis), or treatment for surgical wounds that were not healed, ulcerated, or fractured; within 4 weeks prior to the first administration or within 5 half-lives (whichever is shorter) received anti-tumor treatments such as chemotherapy, biological therapy, endocrine therapy, targeted therapy, or immunotherapy.
Patients with prior or concurrent occurrence of other malignancies, with the following exceptions: a) Carcinoma in situ of the cervix or breast, curatively treated with no signs of recurrence for at least 3 years prior to the study; b) The primary malignancy was completely resected and in complete remission for ≥ 5 years;

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
TMT101 InjectionThree dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. The initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. TMT101 will be injected intramuscularly, Once a week,a total of 9 times	Biological	TMT101 Injection monotherapy

Primary outcome

dose-limiting toxicities (DLTs)
Time frame: within 21 days since the first dose
Occurrence of dose-limiting toxicities (DLTs) within 21 days since the first dose
treatment-emergent adverse events (TEAEs)
Time frame: up to 2 years
occurrence of treatment-emergent adverse events (TEAEs) and grade according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
treatment related adverse event (TRAE)
Time frame: up to 2 years
Occurrence and grade of treatment related adverse event (TRAE) according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
immune-related Adverse Event(irAE）
Time frame: up to 2 years
Occurrence and grade of immune-related Adverse Event(irAE）according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Serious Adverse Event(SAE）
Time frame: up to 2 years
Occurrence and grade of Serious Adverse Event(SAE）according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0
Recommended Dose（RD）
Time frame: the whole escalation phase within 21 days since the first dose
During the dose escalation phase, the MTD and/or available safety, biomarker, and efficacy data will be evaluated thoroughly to determine the RD of TMT101 Injection alone . Three dose levels are planned to be explored: 0.1 mg, 0.2 mg, and 0.4 mg. Once the initial dose is 0.1 mg with a dose reduction for safety reasons, the level of dose reduction will be discussed jointly between the investigator and the sponsor. If the highest dose level of 0.4 mg is not confirmed as a possible recommended therapeutic dose (RD), it may be escalated to a higher dose to determine the possible RD under the condition that investigator and the sponsor to decide together.

7 secondary outcomes

Objective response rate (ORR)
Time frame: up to 2 years
Disease control rate (DCR)
Time frame: up to 2 years
Progression-free survival (PFS)
Time frame: up to 2 years
Overall survival (OS)
Time frame: up to 2 years
Peak time (Tmax) of cationic lipids
Time frame: up to 9 weeks
Peak concentration (Cmax) of cationic lipids
Time frame: up to 9 weeks
Area under the drug concentration -time curve (AUC) of cationic lipids
Time frame: up to 9 weeks

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 11 Aug 2025.

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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.

Wenming Wu, PhD contact

010-69156874 ext. 010-69155709

pumchkyc@126.com

Wenming Wu, PhD principal investigator

Peking Union Medical College Hospital

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 TMT101 Injection in people with Non-small Cell Lung Cancer, run by Peking Union Medical College Hospital 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 13 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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?

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 Wenming Wu, PhD (010-69156874 ext. 010-69155709, pumchkyc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

dose-limiting toxicities (DLTs) (time frame: within 21 days since the first dose). The study lists 6 primary outcomes in all. 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 NCT06861543.

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 11 Aug 2025.