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

Recruiting at 1 trial location

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

18 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment in patients whose previous treatments did not work. The goal is to find out how safe and effective the new treatment is.

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.

What evidence supports the effectiveness of the drug ASCA101?

Research on AS101, a component of ASCA101, shows it can help the immune system fight cancer by increasing certain immune responses and making cancer cells more sensitive to chemotherapy. This suggests ASCA101 might be effective in treating conditions involving abnormal immune responses or cancer. ^{1 2 3 4 5}

What safety data exists for ASCA101 (also known as AS101)?

AS101 is a compound with immunomodulating properties and has been found to have minimal toxicity in studies. It has shown anti-tumor effects in various models and is currently being used in clinical studies, suggesting it is generally safe for human use. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

Interventions

• ASCA101

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Differential effect of the immunomodulator AS101 on B7-1 and B7-2 costimulatory molecules: role in the antitumoral effects of AS101. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Loss of chromosome 9p21 is associated with a poor prognosis in adenosquamous carcinoma of the pancreas. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Ammonium trichloro(dioxoethylene-o,o')tellurate (AS101) sensitizes tumors to chemotherapy by inhibiting the tumor interleukin 10 autocrine loop. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Prognostic values and immune suppression of the S100A family in pancreatic cancer. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Therapeutic effect of TRC105 and decitabine combination in AML xenografts. [2021]

6. Greece pubmed.ncbi.nlm.nih.gov

Inhibition of B16 melanoma metastasis by the immunomodulator AS101. [2019]

7. England pubmed.ncbi.nlm.nih.gov

The immunomodulator AS101 induces growth arrest and apoptosis in multiple myeloma: association with the Akt/survivin pathway. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Multiple signal transduction pathways are involved in G2/M growth arrest and apoptosis induced by the immunomodulator AS101 in multiple myeloma. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

The biological activity and immunotherapeutic properties of AS-101, a synthetic organotellurium compound. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Phase I clinical trial of KML001 monotherapy in patients with advanced solid tumors. [2021]