OncoMatch/Clinical Trials/NCT06861543
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)
Is NCT06861543 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies TMT101 for non-small cell lung cancer.
Treatment: TMT101 — 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
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Small Cell Lung Carcinoma
Biomarker criteria
Allowed: EGFR sensitizing mutation
if the previous test for EGFR-sensitive mutations ... is positive, treatment with a third-generation TKI must be failed or intolerant
Allowed: ALK fusion
if the previous test for ... ALK fusion genes is positive, treatment with a third-generation TKI must be failed or intolerant
Disease stage
Required: Stage IV (AJCC 8th edition)
Metastatic disease required
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
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: chemotherapy
pancreatic cancer: Previous failure or intolerance of two or more lines of chemotherapy
Must have received: platinum-based chemotherapy
NSCLC: Previous failure or intolerance of platinum-containing chemotherapy
Must have received: anti-PD-1 therapy
NSCLC: Previous failure or intolerance of ... anti-PD-1/PD-L1 monoclonal antibodies
Must have received: anti-PD-L1 therapy
NSCLC: Previous failure or intolerance of ... anti-PD-1/PD-L1 monoclonal antibodies
Must have received: third-generation EGFR tyrosine kinase inhibitor
if the previous test for EGFR-sensitive mutations ... is positive, treatment with a third-generation TKI must be failed or intolerant
Must have received: third-generation ALK inhibitor
if the previous test for ... ALK fusion genes is positive, treatment with a third-generation TKI must be failed or intolerant
Lab requirements
Blood counts
ANC≥1.5×10^9/L; PLT≥90×10^9/L; Hb≥90 g/L
Kidney function
Ccr≥50 mL/min
Liver function
TBIL≤1.5×ULN; without liver metastases, AST and ALT ≤ 2.5×ULN; liver metastases, AST and ALT ≤5×ULN
Adequate organ function, meet the following laboratory standards: ANC≥1.5×10^9/L; PLT≥90×10^9/L; Hb≥90 g/L; TBIL≤1.5×ULN; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify