Solid TumorPhase 1NCT05547906
Evaluation of the Safety and Efficacy of ASCA101 in Patients With Advanced Solid Tumors
A Phase 1 study testing ASCA101 in people with Solid Tumor, run by MetaFines at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- ASCA101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 8 Nov 2021to 29 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.)
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- < 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
- QTcF interval > 470 msec on screening electrocardiogram (ECG)
- Clinically significant NCI-CTCAE v5.0 Grade ≥ 1 (allowing Grade ≥ 2 alopecia) ongoing toxicities from previous anticancer treatment.
- Severe infection or severe traumatic systemic disorders.
- Symptomatic or uncontrolled metastasis to central nervous system (CNS) (a patient with asymptomatic CNS metastasis may participate in the study if systemic corticosteroids were discontinued ≥ 4 weeks prior and the patient is radiologically and neurologically stable for ≥ 4 weeks).
- Severe neurological or psychiatric disorders that might have an impact on study results in the opinion of the investigator.
- Pregnant or lactating women or patients planning a pregnancy during the study period.
- Participation in another clinical trial within 30 days prior to the 1st treatment.
- History of bleeding or digestive disorders:
- Evidence of active bleeding, bleeding diathesis, coagulopathy, or tumor with macrovascular invasion
- Clinically significant digestive ulcer, gastrointestinal (GI) bleeding, GI or non-GI fistula, perforation, intra-abdominal abscess, clinical symptoms and signs of GI obstruction, patients requiring parenteral fluids or nutrition, history of digestive disorders such as inflammatory bowel disease
- Evidence of pneumoperitoneum unexplained by recent surgery or paracentesis
- Treatment with biguanides (e.g., metformin) within 2 weeks prior to the 1st treatment or anticipated required treatment with biguanides during the study period.
- Patients requiring continuous treatment with systemic corticosteroids. However, the following will be permitted:
- Use of local corticosteroids such as local intra-articular, intra-nasal, intra-ocular, or inhaled corticosteroids or temporary use of systemic corticosteroids for the treatment and prevention of adverse events (AEs) or allergic reactions to contrast agents will be permitted.
- Patients with HIV and other severe diseases that would limit a patient's participation in the study in the opinion of the investigator (medically controlled diseases will be permitted).
- Having ascites and/or pleural fluid drained within 14 days prior to screening.
- Hemoptysis within 14 days prior to screening (≥ 1/2 teaspoonful cherry red blood per episode).
- Core biopsy or any other minor surgical procedure within 14 days prior to initial IP dose (except for placing a vascular access).
- Serious, unhealed scars, active ulcers, or untreated fractures.
- History of cerebrovascular accident (stroke), transient ischemic attack, or subarachnoid hemorrhage within 6 months prior to screening.
- History of glucose-6-phosphate dehydrogenase deficiency.
- Individuals ineligible for this study for other reasons in the opinion of the investigator.
- Patients identified with hypercalcemia (corrected calcium concentration > 10.4 mg/dL (2.6mmol/L)) identified during the screening period.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
California Research Institute
Los Angeles, California, 90027
South Korea1 site
Seoul national university bundang hospital
Seongnam-si, Gyeonggi-do, 13620
About this study
Official title: 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
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
- Being tested
- ASCA101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASCA101Drug
IV infusion Twice a Week, 8 times per each Cycle
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: ASCA101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4weeks
Secondary outcomes (3)
Objective response rate(ORR)
The proportion of patients achieving a partial response (PR) or complete response (CR) per RECIST 1.1
Measured: From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023]
Progression Free Survival(PFS)
Time from first dose until disease progression or death using RECIST 1.1
Measured: From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023]
Duration of Response(DoR)
Time from first PR or CR until disease progression or death using RECIST 1.1
Measured: From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start8 Nov 2021
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetaFines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547906
- Sponsor's protocol ID
- MF-ASCA101-01
- Status last verified
- Mar 2024
- First submitted
- 14 Sep 2022
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05547906
- Acronym / sponsor ID
- MF-ASCA101-01
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- MetaFinesIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ASCA101 IV | Experimental | Drug: ASCA101The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- 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.
Key exclusion criteria (38 listed)
- 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:
- History of cardiovascular disorders within the past 5 years:
- Clinically significant NCI-CTCAE v5.0 Grade ≥ 1 (allowing Grade ≥ 2 alopecia) ongoing toxicities from previous anticancer treatment.
- Severe infection or severe traumatic systemic disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASCA101IV infusion Twice a Week, 8 times per each Cycle | Drug | ASCA101 IV |
Primary outcome
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
3 secondary outcomes
Objective response rate(ORR)
Time frame: From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023]
Progression Free Survival(PFS)
Time frame: From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023]
Duration of Response(DoR)
Time frame: From first dose until documented disease progression or death, up to 36 months or until database cutoff date of 14Jul2023]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ASCA101 in people with Solid Tumor, run by MetaFines at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 38 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerated dose(MTD) (time frame: 4weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2024.