Trial · NCT04939701
Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants
NCT04939701, Phase 1, Phase 2, Terminated, Astellas Pharma Global Development, Inc.; results first posted 2024-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants. Trials, record NCT04939701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04939701
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants
- NCT number
- NCT04939701
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 16 participants, actual
- Lead sponsor
- Astellas Pharma Global Development, Inc.
- Conditions
- Ovarian Cancer, NSCLC, ESCC, Solid Tumors
- Interventions
- ASP0739
- First posted
- 2021-06-25
- Last updated
- 2024-12-11
- Results first posted
- 2024-08-06
Source ClinicalTrials.gov
Registered outcomes39
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 Day 1 (C1D1) up to C1D28 | DLT was defined as any event occurring within 28 days of first dose on C1D1 and graded as: * Grade (GR) ≥2 autoimmune reaction * GR 3 Immune related AEs (irAEs) that did not resolve to GR ≤1 in 3 to 5 days, febrile neutropenia with or without infection, thrombocytopenia with bleeding requiring transfusion, anemia requiring transfusion * GR 4 irAEs, neutropenia, thrombocytopenia, anemia * GR ≥3 non-hematological AE that did not resolve to GR ≤2 within 72 hours of onset, liver function test abnormality lasting ≥7 days Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>5 × upper limit of normal (ULN; GR≥3) without liver metastases and 8 × ULN in participants with liver metastases, AST or ALT \>3 × ULN and total bilirubin (TBL) \>2 × ULN (in participants with, Gilbert syndrome: AST or ALT \>3 × ULN and direct bilirubin \>1.5) (confirmed Hy's Law) * GR 5 toxicity, Prolonged delay (\>2 weeks) in initiating cycle 2 due to treatment-related toxicity. |
| Primary | Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | From first dose up to 198 days | An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. A treatment-emergent adverse event (TEAE) was defined as an AE observed after the date of first dose until 30 days after the last dose. |
| Primary | Number of Participants With ECOG Performance Status at C1D2 | At C1D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C1D8 | At C1D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at CID15 | At CID15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at CID22 | At CID22 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D1 | At C2D1 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D2 | At C2D2 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D8 | At C2D8 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
| Primary | Number of Participants With ECOG Performance Status at C2D15 | At C2D15 | The ECOG Scale was used to assess performance status. Grade Description: 0 - Fully active, able to carry on all pre disease performance without restriction. 1. \- Restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work. 2. \- Ambulatory and capable of all self-care, but unable to carry out any work activities. Up and about more than 50% of waking hours. 3. \- Capable of only limited self-care, confined to bed or chair more than 50% of waking hours. 4. \- Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair. 5. -Dead. |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 registered outcomesOutcomes39
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 Day 1 (C1D1) up to C1D28 | DLT Evaluation Analysis Set (DEAS).The DEAS was defined as all participants in SAF excluding participants who met any of the following criteria:~* Participant was discovered to have enrolled without fully satisfying eligibility criteria.~* Participant received less than the planned dose in cycle 1 for reasons other than DLT.~* Participant had no DLT and withdrew from the study before the end of DLT evaluation period. | Participants | NUMBER |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | From first dose up to 198 days | SAF | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at C1D2 | At C1D2 | SAF with available data analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at C1D8 | At C1D8 | SAF | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at CID15 | At CID15 | SAF with available data analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at CID22 | At CID22 | SAF with available data analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at C2D1 | At C2D1 | SAF with available data analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at C2D2 | At C2D2 | SAF with available data analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at C2D8 | At C2D8 | SAF with available data analyzed. | Participants | NUMBER |
| PRIMARY | Number of Participants With ECOG Performance Status at C2D15 | At C2D15 | SAF with available data analyzed. | Participants | NUMBER |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 outcomesResults by group373
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 0 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | TEAEs | 4 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | TEAEs | 7 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | TEAEs | 5 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | SAEs | 1 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | SAEs | 2 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) & Serious Adverse Events (SAEs) | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | SAEs | 1 | Participants | |
| Number of Participants With ECOG Performance Status at C1D2 | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | Grade 0 | 3 | Participants |
1 to 10 of 373Source ClinicalTrials.gov
See all 373 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Phase 1: Dose Escalation (168 Days) | STARTED | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 4 | |
| Phase 1: Dose Escalation (168 Days) | STARTED | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 7 | |
| Phase 1: Dose Escalation (168 Days) | STARTED | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 0 | |
| Phase 1: Dose Escalation (168 Days) | COMPLETED | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 1 | |
| Phase 1: Dose Escalation (168 Days) | COMPLETED | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 0 | |
| Phase 1: Dose Escalation (168 Days) | COMPLETED | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 0 | |
| Phase 1: Dose Escalation (168 Days) | NOT COMPLETED | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 3 | |
| Phase 1: Dose Escalation (168 Days) | NOT COMPLETED | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 7 | |
| Phase 1: Dose Escalation (168 Days) | NOT COMPLETED | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 0 | |
| Phase 2: Dose Expansion (168 Days) | STARTED | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events216
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 1 | 4 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 1 | 7 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 0 | 5 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 1 | 4 | 1 |
| other | Leukocytosis | Blood and lymphatic system disorders | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 0 | 7 | 0 |
| other | Leukocytosis | Blood and lymphatic system disorders | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 0 | 5 | 0 |
| other | Palpitations | Cardiac disorders | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 1 | 4 | 1 |
| other | Palpitations | Cardiac disorders | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 0 | 7 | 0 |
| other | Palpitations | Cardiac disorders | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 0 | 5 | 0 |
| other | Sinus tachycardia | Cardiac disorders | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 0 | 4 | 0 |
1 to 10 of 216Source ClinicalTrials.gov
See all 216 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 3 | 4 |
| Total, all-cause mortality | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 2 | 7 |
| Total, all-cause mortality | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 1 | 5 |
| Total, other adverse events | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 4 | 4 |
| Total, other adverse events | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 7 | 7 |
| Total, other adverse events | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 4 | 5 |
| Total, serious adverse events | Dose Escalation (Phase 1): ASP0739 1x10^7 Cells/mL | 1 | 4 |
| Total, serious adverse events | Dose Escalation (Phase 1): ASP0739 1x10^8 Cells/mL | 2 | 7 |
| Total, serious adverse events | Dose Expansion (Phase 2): ASP0739 1x10^8 Cells/mL | 1 | 5 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT04939701
GET https://conductscience.org/api/trials/v1/NCT04939701/registered?page=2