An Open-label, Dose-escalation, Dose-expansion, Phase 1 Study to Evaluate the Tolerability, Safety, Pharmacokinetics/Pharmacodynamics, and Antitumor Effect of ASCA101 in Patients With Advanced Solid Tumors

MetaFines2 sites in 2 countries18 target enrollmentNovember 8, 2021

ConditionsSolid Tumor

InterventionsASCA101

DrugsASCA101

Overview

Phase: Phase 1
Intervention: ASCA101
Conditions: Solid Tumor
Sponsor: MetaFines
Enrollment: 18
Locations: 2
Primary Endpoint: Maximum tolerated dose(MTD)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 8, 2021

End Date

February 29, 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

MetaFines

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.
•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.
•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.
•Life expectancy ≥ 12 weeks.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤
•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 \[no menstruation for ≥ 12 months for no other medical reasons\]).

Exclusion Criteria

•History of hypersensitivities to any of the components of the IP or the same class of drugs as the IP.
•At the time of the 1st treatment:
•\< 4 weeks from a major surgery, if applicable
•\< 2 weeks from a minor surgery, if applicable
•\< 3 weeks from the last radiotherapy, if applicable
•\< 5 x half-life or \< 3 weeks, whichever is longer, from chemotherapy or hormone therapy, if applicable (those who were treated with nitrosoureas or mitomycin within 6 weeks prior to the 1st treatment or targeted biological antibodies within 4 weeks prior to the 1st treatment were not allowed to participate in the study.)
•\< 4 weeks from anticancer immunotherapy, if applicable
•History of cardiovascular disorders within the past 5 years:
•New York heart association (NYHA) class ≥ II (or left ventricle ejection fraction ≤ 50%) congestive heart failure (CHF)
•Uncontrolled hypertension (systolic blood pressure \[SBP\]/diastolic blood pressure \[DBP\] \> 140/90 mmHg)

Arms & Interventions

ASCA101 IV

The study drug, ASCA101(300mg/vial), will be reconstituted in water for injection and diluted with saline to a dose calculated according to individual body surface area or body weight.

Intervention: ASCA101

Outcomes

Primary Outcomes

Maximum tolerated dose(MTD)

Time Frame: 4weeks

MTD will be defined as the maximum dose level at which no more than 1 of 3 participants experience a dose-limiting toxicity (DLT) within the first 4 weeks of dosing

Secondary Outcomes

Objective response rate(ORR)(From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023])
Progression Free Survival(PFS)(From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023])
Duration of Response(DoR)(From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023])