ASP1002 for Cancer

Recruiting at 14 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety of a new treatment called ASP1002 for people with certain types of advanced cancer. It will explore how well patients can tolerate ASP1002 and determine the best dose for future use. The trial will occur in two parts: first, testing various doses to identify the most suitable ones, and then using those doses in further testing. People with metastatic or locally advanced solid tumors who have high levels of a specific protein called claudin 4 might be suitable candidates if they have tried or refused standard treatments. As a Phase 1 trial, this research focuses on understanding how ASP1002 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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.

Is there any evidence suggesting that ASP1002 is likely to be safe for humans?

Research shows that ASP1002 is being tested for safety and tolerance in people with solid tumors. The study aims to determine the right dose and assess how participants handle the treatment. This marks the first human trial of ASP1002, making it crucial to observe reactions to various doses.

Earlier lab tests (not on humans) demonstrated that ASP1002 can effectively combat tumors and appears safe. This suggests potential safety for humans, but the current study focuses on confirming this. As an early-phase trial, the primary goal is to ensure safety by monitoring for any medical problems or side effects at each dose level.

Researchers will closely monitor participants, noting any issues. This process helps identify the highest safe dose and assesses how well participants tolerate ASP1002. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for cancer?

Researchers are excited about ASP1002 because it offers a novel approach to treating cancers like urothelial carcinoma, colorectal cancer, and non-small cell lung cancer. Unlike traditional treatments that might rely on chemotherapy or radiation, ASP1002 works by targeting specific cancer pathways, potentially leading to more precise and effective treatment. This targeted mechanism could result in fewer side effects compared to conventional therapies. By honing in on the unique characteristics of cancer cells, ASP1002 aims to deliver more personalized treatment options, which is a promising step forward in cancer care.

What evidence suggests that ASP1002 could be an effective treatment for cancer?

Research has shown that ASP1002 holds promise for treating solid tumors. Early studies found that ASP1002 can effectively fight tumors and is generally safe. In this trial, participants will receive ASP1002 in different treatment arms, including those for urothelial carcinoma, colorectal cancer, and non-small cell lung cancer. Tests with mice that have human-like immune systems showed that ASP1002 worked well against human lung cancer cells, suggesting potential benefits for non-small cell lung cancer. This treatment targets a protein called claudin 4, found in high amounts in some cancers, such as bladder and colon cancer. Although information from human studies remains limited, initial results for ASP1002 are encouraging. ^{1 2 4 6 7}

Who Is on the Research Team?

Medical Director

Principal Investigator

Astellas Pharma Global Development, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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 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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05719558

A Study of ASP1002 in Adults for Treatment of Solid Tumors The main aims of this study are: To check the safety of ASP1002 in people with certain solid tumors. To check if the people can tolerate ASP1002.

2. healthpartners.com healthpartners.com/institute/research/studies/1002-cl-0101-a-phase-1-study-of-asp1002-in-participants-with-metastatic-or-locally-advanced-solid-tumors/

1002-CL-0101: A Phase 1 Study of ASP1002 in ... Purpose of study: This is a first-in-human study that is looking to study the safety, and tolerability to determine the maximum tolerated dose of study drug ...

3. bioworld.com bioworld.com/articles/714353-first-preclinical-data-on-asp-1002-for-the-treatment-of-solid-tumors

First preclinical data on ASP-1002 for the treatment of solid ... In summary, preclinical results demonstrated that ASP-1002 triggers robust antitumor responses and has a good safety and pharmacokinetics ...

4. jitc.bmj.com jitc.bmj.com/content/jitc/12/Suppl_2/A1482.full.pdf

A NOVEL BISPECIFIC ANTIBODY TARGETING CD137 ... Furthermore, in mice with reconstituted human immune systems, ASP1002 exhibited anti-tumor efficacy against human lung cancer cells and complete ...

5. withpower.com withpower.com/trial/phase-1-neoplasms-2-2023-9ba51

ASP1002 for Cancer · Recruiting Participants for Phase ... 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.

6. yalemedicine.org yalemedicine.org/clinical-trials/a-phase-1-study-of-asp1002-in-participants-with-metastatic-or-locally-advanced-solid-tumors

A Phase 1 Study of ASP1002 in Participants With ... People in this study will continue treatment for up to 2 years (32 cycles) until: they have medical problems or side effects that prevent them from continuing ...

7. careacross.com careacross.com/clinical-trials/trial/NCT05719558

A Study of ASP1002 in Adults for Treatment of Solid Tumors People in this study will continue treatment for up to 2 years (32 cycles) until: they have medical problems or side effects that prevent them from continuing ...