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

NCT05547906 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: MF-ASCA101-01
• Study Type: interventional
• Target: 18
• Locations: 2 countries
• Sites: 2

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose(MTD)

  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

  4weeks

Secondary Outcomes (3)

• 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]

Study Arms (1)

ASCA101 IV

EXPERIMENTAL

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.

Drug: ASCA101

Interventions

ASCA101 DRUG

IV infusion Twice a Week, 8 times per each Cycle

ASCA101 IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ≤ 2.
• 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 \[no menstruation for ≥ 12 months for no other medical reasons\]).
• 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.
• Patients who voluntarily provide written informed consent to participate in the study.

You may not qualify if:

• 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)
• History of hypertensive crisis or hypertensive encephalopathy
• Pulmonary hypertension
• Myocardial infarction
• Significant vascular disease (e.g., aortic aneurysm requiring surgery or recent peripheral artery thrombosis) within 6 months prior to IP initiation
• Uncontrolled arrhythmia

Sponsors & Collaborators

• MetaFines: lead

Study Sites (2)

California Research Institute

Los Angeles, California, 90027, United States

Location

Seoul national university bundang hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 21, 2022
• Study Start: November 8, 2021
• Primary Completion: February 29, 2024
• Study Completion: February 29, 2024
• Last Updated: March 13, 2024

Record last verified: 2024-03

Locations

US (1); KR (1)