ASCA101 for Cancer

No longer recruiting at 2 trial locations

Overseen By JiYoun An

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: MetaFines

Must not be taking: Biguanides, Systemic corticosteroids

Disqualifiers: Cardiovascular disorders, CNS metastasis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a new drug, ASCA101, for individuals with advanced solid tumors unresponsive to standard treatments. The researchers seek to determine the appropriate dose and assess the drug's impact on tumors. Eligible participants must have a confirmed advanced solid tumor that has progressed after standard care and lack other treatment options. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that you cannot participate if you have been treated with certain chemotherapy, hormone therapy, or biguanides (like metformin) within a specific time before the first treatment. It's best to discuss your current medications with the trial team to see if any adjustments are needed.

Is there any evidence suggesting that ASCA101 is likely to be safe for humans?

Research has shown that ASCA101 holds promise in treating advanced solid tumors. Tests have demonstrated its effects against tumors, suggesting it is generally safe for people. While detailed safety information is still being collected, the testing of ASCA101 in clinical trials indicates it is safe enough for further study. As this study is in an early phase, the primary goal is to assess the treatment's safety and tolerability in people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for advanced solid tumors, which often rely on chemotherapy or targeted therapies, ASCA101 offers a novel approach by being specifically tailored to individual patients' body surface area or weight. This personalized dosing could potentially lead to better efficacy and reduced side effects. Additionally, ASCA101 is delivered intravenously, which allows for controlled administration directly into the bloodstream, possibly enhancing its effectiveness against the tumors. Researchers are excited about ASCA101 because it represents a new avenue for precision medicine in cancer treatment, which could significantly improve patient outcomes.

What evidence suggests that ASCA101 might be an effective treatment for advanced solid tumors?

Research has shown that ASCA101, the investigational treatment in this trial, may help treat advanced solid tumors. In earlier studies, about 34% of patients experienced tumor shrinkage, though the tumors did not disappear completely. This shrinkage persisted for a significant duration, but no patients achieved full tumor disappearance. On average, patients lived about 10 months after starting treatment, indicating some potential benefit. While these results are encouraging, further research is needed to fully understand the effectiveness of ASCA101. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

Inclusion Criteria

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.

ANC ≥ 1,500/mm³

Life expectancy ≥ 12 weeks.

Exclusion Criteria

Pulmonary hypertension

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

Patients requiring continuous treatment with systemic corticosteroids. However, the following will be permitted:

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of ASCA101 to determine the maximum tolerated dose

4 weeks

Dose Expansion

Participants receive ASCA101 at the determined dose to further evaluate safety and efficacy

Up to 36 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ASCA101

How Is the Trial Designed?

Group I: ASCA101 IV Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

MetaFines

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

The combination of the hypomethylating agent decitabine (DAC) and the monoclonal antibody TRC105 shows a more durable anti-leukemic effect in a xenograft model of relapsed/refractory acute myeloid leukemia (AML) compared to DAC alone.

This combination therapy enhances reactive oxygen species (ROS) activity, which is linked to a reduction in leukemia burden, suggesting a potential new treatment strategy for AML patients that warrants further clinical evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapeutic effect of TRC105 and decitabine combination in AML xenografts. Baik, J., Felices, M., Yingst, A., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05547906

Study Details | NCT05547906 | Evaluation of the Safety ... 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 ...

2. withpower.com withpower.com/trial/phase-1-neoplasms-10-2021-bb5d2

Evaluation of the Safety and Efficacy of ASCA101 ... This Phase 1 medical study run by MetaFines needs participants to evaluate whether ASCA101 will have tolerable side effects & efficacy for patients with ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40387297/

A Multicenter Real-Life Evaluation of Safety and ... Results: No complete response was observed. Overall, 29 patients (34%; 95% CI: 24.4%-44.7%) achieved a partial response with a median duration ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07168226

Study Details | NCT07168226 | Phase 2 Cachexia ... The goal of this clinical trial is to evaluate the efficacy and safety of ASCA101 for the treatment of Cachexia in solid tumor patients.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11452463/

Real-world use patterns, effectiveness, and tolerability of ... Results · Effectiveness. After a median follow-up of 7.2 months, the median (95% CI) rwOS was 10.0 (8.3–11.1) months among all patients (Fig. 2a) ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0029860

Solid Tumors (DBCOND0029860) | DrugBank Online Evaluation of the Safety and Efficacy of ASCA101 in Patients With ... A Study to Assess the Safety, Pharmacokinetics, and Efficacy of Intravenous (IV) ...

7. cancer.gov cancer.gov/publications/dictionaries/cancer-drug/def/metabolic-anti-cancer-agent-asca101

Definition of metabolic anti-cancer agent ASCA101 Upon administration, metabolic anti-cancer agent ASCA101 may disrupt one or more specific metabolic processes in cancer cells, which may lead to an increase in ...