Actively Recruiting
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)
Led by Peking Union Medical College Hospital · Updated on 2025-08-11
18
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Agrees to follow the trial protocol and visit schedule and has signed informed consent
- 18 years of age or older at time of consent
- Diagnosed with advanced, unresectable, or metastatic pancreatic cancer or non-small cell lung cancer confirmed by histology or cytology
- For pancreatic cancer, previous failure or intolerance of two or more chemotherapy lines
- For NSCLC, previous failure or intolerance of platinum chemotherapy and anti-PD-1/PD-L1 therapy, and if EGFR or ALK positive, failure or intolerance of third-generation TKI
- At least one measurable lesion per RECIST 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Estimated life expectancy of at least 12 weeks
- Adequate organ function meeting specified blood, liver, kidney, and coagulation lab standards
- Males and females of childbearing potential willing to use effective contraception from consent until 6 months after last dose
- Females of childbearing potential must have a negative pregnancy test within 7 days before first dose
You will not qualify if you...
- Allergy to TMT101 Injection or its components
- Uncontrolled illnesses including active infections, uncontrolled hypertension, hyperglycemia, heart failure, unstable angina, arrhythmias, ascites or pleural effusion grade 2 or higher, thrombosis, active autoimmune disease, psychiatric disease, active peptic ulcer, or bleeding disorders
- Use of immunosuppressive drugs within 3 weeks prior to first dose, except low-dose topical or inhaled corticosteroids
- Major surgery, radiotherapy (except bone metastasis palliative), or unhealed wounds within 4 weeks prior to first dose
- Anti-tumor treatments within 4 weeks or 5 half-lives prior to first dose
- Other malignancies except carcinoma in situ or completely resected primary malignancy in remission for specified periods
- History or current interstitial lung disease or pneumonitis requiring systemic steroids
- Positive for certain infections including syphilis, HIV, hepatitis B or C
- Receipt or planned receipt of live vaccines within 4 weeks before or after treatment
- History of organ or hematopoietic stem cell transplantation
- Participation in other interventional trials within 3 weeks before first dose
- Prior grade 3 or higher immune-related adverse events leading to treatment discontinuation
- Pregnant or lactating women
- Any other conditions affecting compliance or suitability
- Active central nervous system metastases except asymptomatic brain metastases
- Unresolved toxicities from prior therapies above grade 1 except certain exceptions
- Major surgery within 4 weeks prior to first dose
- Unsuitable for study due to transsplenectomy as judged by investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
W
Wenming Wu, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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