ASP1002 for Cancer

Recruiting at 13 trial locations

Overseen By Astellas Pharma Global Development, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Astellas Pharma Global Development, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: CNS metastases, Autoimmune disease, Cardiac disease, others

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

Compensation: Varies

Number of Visits: 1

210 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing ASP1002, a new medicine for certain cancers. It focuses on adults with advanced tumors that haven't responded to other treatments. Researchers aim to understand how the body processes ASP1002 and its side effects, to find the best dose for future use.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on certain cancer treatments, you may need to stop them before starting the trial. It's best to discuss your specific medications with the study team.

How is the drug ASP1002 unique for cancer treatment?

ASP1002 may be unique because it involves S100P, a protein that plays a role in cancer cell growth and spread. S100P is linked to increased cancer cell movement and invasion, making it a potential target for treating cancers where this protein is overexpressed. ^{1 2 3 4 5}

Research Team

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Eligibility Criteria

Adults with advanced solid tumors and high claudin 4 levels, who've tried standard treatments or refused them, can join. They must be fairly active (ECOG Status of 0 or 1), expected to live at least 12 weeks, have good organ function, and a measurable tumor. Pregnant women can't join; participants must agree to contraception.

Inclusion Criteria

I have recent tumor tissue samples available.

My cancer is advanced and cannot be removed by surgery.

I will not donate eggs during the trial.

Exclusion Criteria

I have not had major surgery in the last 28 days.

I have untreated brain metastases.

Participant has an active autoimmune disease.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1: Dose Escalation

Participants receive sequentially escalating doses of ASP1002 to determine suitable doses for Part 2

Up to 24 months

Weekly or bi-weekly visits for infusions and health checks

Treatment Part 2: Dose Expansion

Participants receive doses of ASP1002 determined from Part 1

Up to 24 months

Weekly or bi-weekly visits for infusions and health checks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 12 months

Visits at 1 month, 3 months, and up to 1 year after last dose

Treatment Details

Interventions

• ASP1002

Trial Overview ASP1002 is being tested in two parts: first to find safe doses by giving it through an IV in increasing amounts to small groups. Then the best doses are used on different groups for up to two years or until side effects become too severe.

Participant Groups

Group I: Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC) Experimental Treatment 1 Intervention

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Group II: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC) Experimental Treatment 1 Intervention

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Group III: ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC) Experimental Treatment 1 Intervention

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Group IV: ASP1002 Dose Escalation (Part 1) Experimental Treatment 1 Intervention

Participants will be assigned to sequentially escalating doses of ASP1002. Each dose level will open sequentially based upon sponsor review of emerging data.

Who Is Running the Clinical Trial?

Astellas Pharma Global Development, Inc.

Lead Sponsor

Trials

204

Recruited

123,000+

Tadaaki Taniguchi

Astellas Pharma Global Development, Inc.

Chief Medical Officer

M.D., Ph.D.

Naoki Okamura

Astellas Pharma Global Development, Inc.

Chief Executive Officer

Not available

Findings from Research

In a study of 121 patients with resectable gastric cancer, those with positive S100P expression had a significantly higher 5-year cumulative survival rate (20.3%) compared to those with negative expression (3.5%), suggesting S100P may serve as a novel independent prognostic factor.

The overexpression of S100P in gastric cancer cells increased their sensitivity to the chemotherapy drug oxaliplatin, as indicated by a lower half-inhibitory concentration (IC50) in S100P-overexpressing cells, which could enhance treatment outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Impact of S100P expression on clinical outcomes of gastric cancer patients with adjuvant chemotherapy of oxaliplatin and its mechanisms]. Zhao, XM., Bai, ZG., Ma, XM., et al.[2018]

S100P is significantly overexpressed in endometrial squamous cell carcinoma and adenosquamous carcinoma, suggesting its potential as a specific biomarker for these cancer subtypes.

The study indicates that S100P promotes tumor growth by enhancing cell proliferation, invasion, and migration while inhibiting apoptosis, likely through activation of the PI3K-AKT and MAPK pathways, making it a potential target for therapeutic intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

S100P is Overexpressed in Squamous Cell and Adenosquamous Carcinoma Subtypes of Endometrial Cancer and Promotes Cancer Cell Proliferation and Invasion. Jiang, H., Hu, H., Lin, F., et al.[2017]

S100P is a key protein that promotes migration, invasion, and metastasis in lung cancer cells, with its effects linked to increased interaction with integrin α7 and activation of signaling pathways like FAK and AKT.

Knocking down S100P not only reduces cancer cell movement and invasion but also prevents the spread of highly metastatic lung cancer in animal models, suggesting that targeting S100P could be a promising strategy for lung cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

S100P interacts with integrin α7 and increases cancer cell migration and invasion in lung cancer. Hsu, YL., Hung, JY., Liang, YY., et al.[2018]

S100P is a protein linked to various cancers, including breast, pancreatic, lung, and ovarian tumors, and is involved in tumor growth and metastasis through its interactions with calcium ions and other proteins.

Due to its elevated levels in tumor cells, S100P has potential as a diagnostic marker and a target for therapy in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calcium-binding protein S100P and cancer: mechanisms and clinical relevance. Jiang, H., Hu, H., Tong, X., et al.[2021]

In a study of 176 gastric cancer patients, S100A9 positive expression was linked to better overall survival (35.1 months) compared to negative expression (20.3 months), suggesting it may serve as a positive prognostic marker.

S100A8 expression did not show a significant association with survival outcomes, indicating that while S100A9 may be beneficial in prognosis, S100A8 does not have the same predictive value in gastric cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical significance of S100A8 and S100A9 expression in gastric cancer]. Hu, Y., Fan, B., Zhang, LH., et al.[2014]

References

1. China pubmed.ncbi.nlm.nih.gov

[Impact of S100P expression on clinical outcomes of gastric cancer patients with adjuvant chemotherapy of oxaliplatin and its mechanisms]. [2018]

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

S100P is Overexpressed in Squamous Cell and Adenosquamous Carcinoma Subtypes of Endometrial Cancer and Promotes Cancer Cell Proliferation and Invasion. [2017]

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

S100P interacts with integrin α7 and increases cancer cell migration and invasion in lung cancer. [2018]

4. Germany pubmed.ncbi.nlm.nih.gov

Calcium-binding protein S100P and cancer: mechanisms and clinical relevance. [2021]

5. China pubmed.ncbi.nlm.nih.gov

[Clinical significance of S100A8 and S100A9 expression in gastric cancer]. [2014]