Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with high TAM were included as one cohort group.

All patients with advanced non-small cell lung cancer who had been treated at the Linkou Branch of Chang Gung Memorial Hospital were included. Tumor specimens with low TAM were included as one cohort group.

Fu-Tsai Chung, M.D.

The purpose of this study is to investigate the effects of tumor associated macrophage (TAM) in advanced non-small cell lung cancer (NSCLC) patients on the treatment response and outcome of these subjects. Pathologic specimens from tissue bank will be stained by immunostaining methods with CD68 antibody. The clinical treatment response and outcomes will be analyzed between high or low TAM.

All specimens were fixed in 10% buffered formalin and embedded in paraffin according to standard procedures. All of the tissues were fixed immediately after biopsy, with time from tissue acquisition to fixation as short as possible. Serial sections (4 μm thickness) placed on positively charged slides (Menzel-Glasser, German) were used for immuno-histochemistry.

Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer

Tumor-Associated Macrophages Correlate With Response and Outcomes in Advanced Non-Small Cell Lung Cancer After First Line Treatment.

All patients with advanced non-small cell lung cancer (NSCLC) who had been treated were included. The decision of advanced NSCLC treatment was a consensus by the patient and clinician, and approved by team conference (including the oncologists, pulmonologists, pathologists, radiologists, surgeons, radiation oncologists, and nuclear medicine specialists). The tumor response was evaluated using computerized tomography according to the Response Evaluation Criteria in Solid Tumors (RECIST). The treatment response of advanced between high and low TAM patients were compared.

The outcomes of advanced NSCLC with high and low TAM will be compared. The outcomes include overall survival (OS) and progression-free survival (PFS). Survival curves were estimated by the Kaplan-Meier method while the log-rank test was used to compare the patient survival times per groups.

Chang Gung Memorial Hospital

Digestive System Diseases

Skin and Connective Tissue Diseases

Rare Diseases

Stomach Neoplasms

Breast Neoplasms

Breast Diseases

Skin Diseases

Stomach Cancer

All Drugs and Chemicals

Antibodies

Immunoglobulins

XMT-1522 treatment will administered in groups of patients who will receive doses that increase over time. Once the maximum tolerated dose or recommended Phase 2 dose is achieved, new groups of patients will receive XMT-1522 at this fixed dose.

one intravenous dose administered in-clinic every 21 days

XMT-1522

Eric P. Hailman, MD, PhD

This Phase 1b trial is an open label, multi-center study of XMT-1522 administered as an intravenous infusion once every three weeks. The dose escalation part of the study will establish the maximum tolerated dose or recommended Phase 2 dose for in patients with advanced breast cancer and either a HER2 immunohistochemistry (IHC) score of at least 1+ using a validated IHC assay or with evidence of HER2 amplification. Patients with HER2 positive (by IHC or amplification) gastric cancer or nonsmall cell lung cancer may also be eligible for participation in dose escalation. Upon completion of dose escalation, the cohort expansion segment of the study will consist of four parallel cohorts of different patients groups to confirm the maximum tolerated dose or the recommended Phase 2 dose and estimate the objective response in each of the patient populations.

The dose escalation segment of the study utilizes a 3+3 design. Initially, 3 patients will be dosed at each dose level. The first 3-week cycle of treatment constitutes the dose limiting toxicity (DLT) evaluation period. If none of the 3 patients experience a DLT during the evaluation period and the Safety Review Committee agrees this was a reasonably well tolerated dose, 3 patients will be enrolled at the next dose level. However, in the event of 1 DLT, 3 additional patients will be enrolled at the same dose level. Any dose level with 2 or more DLTs will be considered to have exceeded the maximum tolerated dose and subsequent patients will be enrolled at lower dose levels. After the first cycle, patients may continue to receive XMT-1522 until disease progression as long as the drug is well-tolerated and patients continue to derive clinical benefit in the opinion of the Investigator.

After completion of the dose escalation, the expansion segment will enroll the patients with the following kinds of cancer:

* Cohort 1: Advanced breast cancer, HER2 IHC 1+, or HER2 IHC 2+ without HER2 gene amplification
* Cohort 2: Advanced breast cancer, HER2-positive, who have received prior ado-trastuzumab emtansine
* Cohort 3: Advanced gastric cancer, HER2-positive, who have received prior trastuzumab
* Cohort 4: Advanced non-small cell lung cancer, HER2 IHC 2+ or 3+, any HER2 gene amplification or mutation status

Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2

A Phase 1b, First-in-Human, Dose Escalation and Expansion Study of XMT-1522 in Patients With Advanced Breast Cancer and Other Advanced Tumors Expressing HER2

Evaluate adverse events and use of concomitant medication use after XMT-1522 doses

Determine the pharmacokinetics of XMT-1522

Analyze blood for antibodies to XMT-1522 and neutralizing antibodies

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tumor Associated Macrophage in Advanced Non-small Cell Lung Cancer	NCT01551251	Advanced Nonsma...		20 Years -	Chang Gung Memorial Hospital
Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2	NCT02952729	Advanced Breast... Advanced Nonsma... Advanced Gastri...	XMT-1522	18 Years -	Mersana Therapeutics
Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2	NCT02952729	Advanced Breast... Advanced Nonsma... Advanced Gastri...	XMT-1522	18 Years -	Mersana Therapeutics

Spots Global Cancer Trial Database for advanced nonsmall cell lung cancer