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Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC) for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Next Oncology Vuerginia, Fairfax, VAAdvanced Solid TumorsASP1002 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial studies a new treatment (ASP1002) for people with certain solid tumors. It aims to learn if it has any medical problems or side effects and to find a suitable dose to use in future studies. People will receive infusions & checks during visits over 2 years.

Eligible Conditions
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

8 Primary · 12 Secondary · Reporting Duration: Up to 28 months

Week 6
Changes in expression levels of Claudin-4 (CLDN4) by immunohistochemistry (IHC)
Incidence rate of Claudin-4 (CLDN4) by immunohistochemistry (IHC)
Up to 12 months
Pharmacokinetics (PK) of ASP1002 in serum: AUC0-7d
Pharmacokinetics (PK) of ASP1002 in serum: Cmax
Pharmacokinetics (PK) of ASP1002 in serum: Ctrough
Pharmacokinetics (PK) of ASP1002 in serum: tmax
Up to 24 months
Incidence of Dose Limiting Toxicities (DLTs) for ASP1002
Number of participants with physical exam abnormalities and/or Adverse Events (AEs)
Up to 25 months
Number of participants with Adverse Events (AEs)
Up to 27 months
Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores
Number of participants with Serious Adverse Events (SAEs)
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Up to 28 months
Disease Control Rate (DCR) per RECIST v1.1
Disease Control Rate (DCR) per iRECIST
Duration of Response (DOR) per RECIST v1.1
Duration of Response (DOR) per iRECIST
Objective Response Rate (ORR) per Immune Response Evaluation Criteria in Solid Tumors (iRECIST)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Trial Safety

Safety Progress

1 of 3

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1
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1
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2
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Trial Design

4 Treatment Groups

Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)
1 of 4
Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)
1 of 4
ASP1002 Dose Escalation (Part 1)
1 of 4
ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)
1 of 4

Experimental Treatment

210 Total Participants · 4 Treatment Groups

Primary Treatment: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC) · No Placebo Group · Phase 1

Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)
Drug
Experimental Group · 1 Intervention: ASP1002 · Intervention Types: Drug
Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)
Drug
Experimental Group · 1 Intervention: ASP1002 · Intervention Types: Drug
ASP1002 Dose Escalation (Part 1)
Drug
Experimental Group · 1 Intervention: ASP1002 · Intervention Types: Drug
ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)
Drug
Experimental Group · 1 Intervention: ASP1002 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 28 months

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
186 Previous Clinical Trials
84,975 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,654 Previous Clinical Trials
7,956,947 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
To participate in the second phase of the study, you must have one of the following types of cancer: Non-Small Cell Lung Cancer (excluding certain types), Urothelial Carcinoma, or Colorectal Cancer. If you had a positive response to the medication during the first phase of the study, you may also be eligible.
You have tried other treatments for your condition but they have not worked or you cannot tolerate them. No specific number of prior treatments is required to be excluded.
References

Frequently Asked Questions

What possible harmful effects could result from administering ASP1002 Dose Escalation (Part 1) to patients?

"Due to the preliminary state of clinical research, our team at Power assigned ASP1002 Dose Escalation (Part 1) a score of one in terms of safety. This is because Phase 1 trials provide limited evidence regarding both efficacy and risk profiles." - Anonymous Online Contributor

Unverified Answer

How many individuals have elected to participate in this trial?

"Affirmative. According to information available on clinicaltrials.gov, this trial is actively recruiting patients since its posting date of February 21st 2023 and was last updated on March 7th 2023. 210 individuals need to be enrolled across two medical locations." - Anonymous Online Contributor

Unverified Answer

Is it still possible for individuals to join this clinical experiment?

"Per the clinicaltrials.gov website, this experiment is currently recruiting volunteers and has been receiving updates since its initiation on February 21st 2023. The most recent edit was made on March 7th of the same year." - Anonymous Online Contributor

Unverified Answer

What are the desired outcomes for this medical experiment?

"The sponsor of this medical trial, Astellas Pharma Global Development Inc., has outlined the primary outcome as Adverse Events (AEs) and physical exam abnormalities over a 24 month period. Secondary outcomes span from Maximum concentration (Cmax), Duration of Response (DOR), to Disease Control Rate (DCR)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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