Evaluation of the Safety and Efficacy of ASCA101 in Patients With Advanced Solid Tumors

• Status: Recruiting
• Trial end date: 2023-10-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective, open-label, dose escalation Phase 1 study. The purpose of this study is to evaluate the following objectives in patients with advanced solid tumors after failure of standard of care.

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

Details

• Lead Sponsor: MetaFines

Criteria

Inclusion Criteria:

1. Patients aged ≥ 18 years with pathologically or cytologically confirmed metastatic or unresectable advanced solid tumors that progressed despite standard of care or which did not tolerate standard of care and for which other standard of care is not available.

2. Patients with the following laboratory test values, obtained within 14 days prior to study enrollment with no history of G-CSF or blood transfusions within 14 days prior to collection of samples for the laboratory tests:

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9.0 g/dL

• CrCl ≥ 60 mL/min calculated using the Cockcroft-Gault formula

• Total bilirubin ≤ 1.5×ULN ⑥ AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell carcinoma) ⑦ INR and aPTT ≤ 1.5×ULN ⑧ Urine protein to creatinine ratio (UPC) < 1.0 (g/g)a a UPC will be performed in patients with at least one positive (+) protein outcome upon urinalysis.

3. At least one evaluable lesion based on the response evaluation criteria in solid tumors (RECIST) version 1.1 as measured by tumor markers or CT/MRI.

4. Life expectancy ≥ 12 weeks.

5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.

6. Women of childbearing potential who test negative for pregnancy (by serum-hCG or urine-hCG at the discretion of the investigator) at the time of study participation (i.e., all women who have had menarche and are not surgically sterile [hysterectomy, bilateral tubal ligation, bilateral ovariectomy, etc.] and are not post-menopausal [no menstruation for ≥ 12 months for no other medical reasons]).

7. Patients who agree to use medically acceptable methods of birth control (patient's or partner's vasectomy, tubal ligation, intrauterine device, barrier contraception, oral contraceptives, diaphragm or condom use in combination) during treatment with the investigational product (IP) and for 6 months after the end of treatment.

8. Patients who voluntarily provide written informed consent to participate in the study.

Exclusion Criteria:

• 1) Patients aged ≥ 18 years with pathologically or cytologically confirmed metastatic or unresectable advanced solid tumors that progressed despite standard of care or which did not tolerate standard of care and for which other standard of care is not available.

2) Patients with the following laboratory test values, obtained within 14 days prior to study enrollment with no history of G-CSF or blood transfusions within 14 days prior to collection of samples for the laboratory tests:

• ANC ≥ 1,500/mm³

• Platelet count ≥ 100,000/mm³

• Hemoglobin ≥ 9.0 g/dL

• CrCl ≥ 60 mL/min calculated using the Cockcroft-Gault formula

⑤ Total bilirubin ≤ 1.5×ULN

⑥ AST, ALT ≤ 3×ULN (≤ 5×ULN for patients with liver metastasis or liver cell carcinoma)

⑦ INR and aPTT ≤ 1.5×ULN

⑧ Urine protein to creatinine ratio (UPC) < 1.0 (g/g)a a UPC will be performed in patients with at least one positive (+) protein outcome upon urinalysis.

3) At least one evaluable lesion based on the response evaluation criteria in solid tumors (RECIST) version 1.1 as measured by tumor markers or CT/MRI.

4) Life expectancy ≥ 12 weeks. 5) Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 6) Women of childbearing potential who test negative for pregnancy (by serum-hCG or urine-hCG at the discretion of the investigator) at the time of study participation (i.e., all women who have had menarche and are not surgically sterile [hysterectomy, bilateral tubal ligation, bilateral ovariectomy, etc.] and are not post-menopausal [no menstruation for ≥ 12 months for no other medical reasons]).

7) Patients who agree to use medically acceptable methods of birth control (patient's or partner's vasectomy, tubal ligation, intrauterine device, barrier contraception, oral contraceptives, diaphragm or condom use in combination) during treatment with the investigational product (IP) and for 6 months after the end of treatment.

8) Patients who voluntarily provide written informed consent to participate in the study.