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ASP2074 Dose Escalation (Part 1) for Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
National Cancer Center Hospital, Chuo-ku, JapanSolid TumorsASP2074 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will study a potential new treatment, ASP2074, for people with certain solid tumors who have already tried standard treatments. They will be given different doses to find the most suitable one, and monitored for any medical problems from the treatment.

Eligible Conditions
  • Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Dose Escalation (Phase 1)
1
Part 1: Dose Escalation
1
Part 3a: ABBV-706 + Budigalimab

Study Objectives

6 Primary · 13 Secondary · Reporting Duration: Up to 21 Months

Month 21
Change from Baseline in Serum CA19-9 levels in participants with pancreatic cancer
Day 40
Change from Baseline in target antigen expression
Change from Baseline in tumor CD8 infiltration/ activation
Up to 12 Months
Pharmacokinetics (PK) of ASP2074 in serum: AUC(0-336h)
Pharmacokinetics (PK) of ASP2074 in serum: Cmax
Pharmacokinetics (PK) of ASP2074 in serum: Ctrough
Pharmacokinetics (PK) of ASP2074 in serum: tmax
Up to 13 Months
Number of participants with laboratory value abnormalities and/or adverse events (AEs)
Up to 15 Months
Number of participants with Adverse Events (AEs)
Number of participants with Serious Adverse Events (SAEs)
Number of participants with electrocardiogram (ECG) abnormalities and/or Adverse Events (AEs)
Number of participants with vital sign abnormalities and/or adverse events (AEs)
Up to 21 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 Immunotherapy Response Evaluation Criteria in Solid Tumors (iRECIST)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Day 28
Incidence of Dose Limiting Toxicities (DLTs) for ASP2074

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Dose Escalation (Phase 1)
1
Part 1: Dose Escalation
1
Part 3a: ABBV-706 + Budigalimab

Trial Design

4 Treatment Groups

ASP2074 Dose Escalation (Part 1)
1 of 4
ASP2074 Dose Expansion (Part 2) Colorectal Adenocarcinoma
1 of 4
ASP2074 Dose Expansion (Part 2) Esophageal or GEJ Adenocarcinoma
1 of 4
ASP2074 Dose Expansion (Part 2) Pancreatic Adenocarcinoma
1 of 4

Experimental Treatment

193 Total Participants · 4 Treatment Groups

Primary Treatment: ASP2074 Dose Escalation (Part 1) · No Placebo Group · Phase 1

ASP2074 Dose Escalation (Part 1)
Drug
Experimental Group · 1 Intervention: ASP2074 · Intervention Types: Drug
ASP2074 Dose Expansion (Part 2) Colorectal Adenocarcinoma
Drug
Experimental Group · 1 Intervention: ASP2074 · Intervention Types: Drug
ASP2074 Dose Expansion (Part 2) Esophageal or GEJ Adenocarcinoma
Drug
Experimental Group · 1 Intervention: ASP2074 · Intervention Types: Drug
ASP2074 Dose Expansion (Part 2) Pancreatic Adenocarcinoma
Drug
Experimental Group · 1 Intervention: ASP2074 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 21 months

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
186 Previous Clinical Trials
84,992 Total Patients Enrolled
Senior Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
54 Previous Clinical Trials
12,884 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Is it possible for new participants to register for this research endeavor?

"This research study is currently recruiting patients, as noted on clinicaltrials.gov. It was first posted to the website and last updated in February of 2023." - Anonymous Online Contributor

Unverified Answer

To what extent can ASP2074 Dose Escalation (Part 1) be perilous to individuals?

"ASP2074 Dose Escalation (Part 1) has a safety rating of 1, due to the limited data available on its efficacy and level of risk. This is an early-stage trial." - Anonymous Online Contributor

Unverified Answer

How many participants have been enrolled in this clinical experiment?

"Affirmative. The records on clinicaltrials.gov verify that this medical trial is presently soliciting participants, which it originally advertised starting January 25th 2023 and adjusted most recently February 20th of the same year. 193 individuals are required to register from a solitary location." - Anonymous Online Contributor

Unverified Answer

What is the desired outcome of this experiment?

"This clinical trial intends to measure the number of Adverse Events experienced by participants over a 28-day period, with secondary objectives including an assessment of Objective Response Rates (ORR) according to iRECIST and RECIST v1.1 criteria along with Duration of Response (DOR)." - 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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