TEW-7197 With Paclitaxel for the Treatment of Metastatic Gastric Cancer

• Status: Active, not recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, single arm study evaluating the safety and tolerability of TEW-7197 in combination with paclitaxel in metastatic gastric cancer patients.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedPacto, Inc.
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

1. Men and women over 19 years of age

2. Patients diagnosed with histologically or cytologically metastatic gastric cancer

3. Patients corresponding to ECOG Performance Status 0

4. The 5-Fluorouracil family (5-Fluorouracil) is the primary treatment for metastatic gastric cancer.

Patients who received additional Trastuzumab coalescing therapy for Cisplatin (Oxaliplatin) and Platinum (Oxaliplatin) or HER2-positive.

5. Patients with evalable lesions according to Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1)

6. Patients with the following laboratory test values during screening:

• Bilirubin is not more than 1.5 times the upper limit of normal (ULN)

• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) not more than 3 times ULN (if liver metastasis, not more than 5 times ULN)

• Serum cretin is not more than 1.5 times the ULN

• Absolute neutrophil count (ANC)가 1,000 cells/µL 이상

• Platelet count is over 80,000/µL

• Hemoglobin count 가 9.0 g/dL 이상

7. Patients who voluntarily agreed to participate in the clinical trial after hearing the explanation of this clinical trial.

Exclusion Criteria:

1. Patients with unresolved chronic toxicity of CTC grade 2 or higher in previous chemotherapy

2. Patients who have received chemotherapy or chemotherapy within two weeks prior to screening

3. Patients who have undergone major surgery or radiation treatment within four weeks prior to screening

4. Patients who have received medication for other clinical trials before screening and have less than 5 times the period of this half-life. Patients who are less than two weeks from the date of final administration if the half-life of the previous clinical trial drug is not clear.

5. Patients previously treated with paclitaxel

6. Patients who previously received treatment targeting the TGF-£ signaling pathway

7. Patients who cannot take tablets

8. Patients who are neurologically unstable due to overall metastasis in the central nervous system or who have increased the amount of steroid to alleviate the central nervous system signs within two weeks before screening.

9. If another type of tumor is present, or within three years prior to screening, another tumor is present.

diagnosed patients (except for single basal cell carcinoma, thyroid cancer and cervical cancer-insitu)

10. Patients with a history of congestive heart failure or myocardial infarction that is not controlled by medication

11. Pregnant women who are positive for pregnancy test results in this clinical trial and contraception by themselves and their partners during the safety follow-up period after treatment (e.g., infertility surgery, intrauterine, oral contraceptives, liver wall contraception, and other hormone delivery systems, creams, jellies, etc.)

12. Patients with evidence of cirrhosis above Child-Pugh B or C. For HBV or HCV-linked chronic hepatitis or cirrhosis Child-Pugh A, it can be registered for clinical trials if the liver function is reliably maintained through medication.

13. Other patients who are deemed unfit to participate in the study