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Cancer Vaccine

ASP0739 for Ovarian Cancer

Phase 1 & 2
Waitlist Available
Research Sponsored by Astellas Pharma Global Development, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer drug, ASP0739, to see if it is safe and effective when used alone or with another cancer drug, pembrolizumab.

Eligible Conditions
  • Ovarian Cancer
  • Non-Small Cell Lung Cancer
  • Esophageal Carcinoma
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Dose Limiting Toxicities (DLTs) for ASP0739 + Pembrolizumab Safety Lead-in
Incidence of Dose Limiting Toxicities (DLTs) for ASP0739 Single Agent
Number of Participants with Serious Adverse Events (SAEs)
+7 more
Secondary outcome measures
DOR per RECIST v1.1 by local assessment
Disease Control Rate per RECIST v1.1 (DCR)
Disease Control Rate per iRECIST (iDCR)
+10 more

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm

Trial Design

4Treatment groups
Experimental Treatment
Group I: Phase 2 ASP0739 Monotherapy Dose ExpansionExperimental Treatment1 Intervention
Participants with R/R SS, MRCL, or ovarian cancer and other solid tumors known to express NY-ESO-1 (melanoma, NSCLC-adenocarcinoma, squamous cell, and ESCC) will receive RP2D of ASP0739 on day 1 of each 28-day cycle for up to 6 doses.
Group II: Phase 2 ASP0739 + Pembrolizumab Safety Lead-inExperimental Treatment2 Interventions
Participants with R/R SS, MRCL or ovarian cancer will receive RP2D of ASP0739 on day 1 of each 28-day cycle for up to 6 doses in combination with pembrolizumab on Cycle 1 Day 1, and then every 6 weeks up to 4 doses during the treatment period to determine the RP2D of ASP0739 with pembrolizumab. A total of 17 doses of pembrolizumab may be available for qualifying participants.
Group III: Phase 2 ASP0739 + Pembrolizumab Dose ExpansionExperimental Treatment2 Interventions
Participants with R/R SS, MRCL, or ovarian cancer will receive RP2D of ASP0739 with pembrolizumab on day 1 of each 28-day cycle for up to 6 doses, in combination with 4 doses of pembrolizumab administered on cycle 1 day 1, and then every 6 weeks during the treatment period. A total of 17 doses of pembrolizumab may be available for qualifying participants.
Group IV: Phase 1 ASP0739 Monotherapy Dose EscalationExperimental Treatment1 Intervention
Participants with R/R solid tumors known to express NY-ESO-1 will receive ASP0739 on day 1 of each 28-day cycle for up to 6 doses, to determine the Recommended Phase 2 Dose (RP2D).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ASP0739
2022
Completed Phase 2
~20
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
192 Previous Clinical Trials
121,046 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,777 Previous Clinical Trials
8,063,470 Total Patients Enrolled
13 Trials studying Ovarian Cancer
3,676 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants is the clinical trial accommodating?

"Affirmative. Clinicaltrials.gov corroborates that the trial, which was publicized on January 11th 2022 and recently updated on November 29th, is currently enrolling 339 patients from 7 different medical facilities."

Answered by AI

To what extent is this clinical trial being conducted in the state?

"Currently, 7 trial sites are accepting applicants. These locations include Aurora, Duarte and Chicago along with 4 additional centres. To reduce travel demands for participants, it is best to select a clinical site nearby your residence when enrolling in this study."

Answered by AI

Are the doors of enrollment for this experiment still open?

"Affirmative. Clinicaltrials.gov indicates that the trial, which was uploaded to the website on January 11th 2022 and last modified on November 29th 2022, is currently enrolling 339 individuals at 7 different sites."

Answered by AI

What other research endeavors have been performed involving ASP0739?

"Currently, 961 trials assessing the efficacy of ASP0739 are ongoing. Of these studies, 122 have advanced to Phase 3 status. These medical experiments can be found in 35731 centers across America with a notable concentration in Houston, Texas."

Answered by AI

What conditions is ASP0739 typically prescribed to treat?

"ASP0739 is a medication commonly used to combat malignant neoplasms. It has also been observed to be effective against unresectable melanoma, microsatellite instability high, and in cases of chemotherapy-resistant cancer progression."

Answered by AI

What kind of results is this experiment anticipated to yield?

"Astellas Pharma Global Development, Inc., the study sponsor, has identified Objective Response Rate per Immune Response Evaluation Criteria in Solid Tumors (iRECIST) (iORR) by Independent Central Review as its primary outcome. This will be observed and measured over a 27-month period. In addition to this metric, researchers are also monitoring iPFS per iRECIST by local assessment - defined as the time from treatment commencement until death or radiographic disease progression; Disease Control Rate per iRECIST (iDCR); and Duration of Overall Survival (OS)."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants
2022. "Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04939701.
~5 spots leftby Apr 2025
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