Study of ASP0739 Alone and With Pembrolizumab in Advanced Solid Tumors With NY-ESO-1 Expression Participants

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.

Time frame: Cycle 1 Day 1 (C1D1) up to C1D28

Population: 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.

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.

Time frame: At C1D2

Population: SAF with available data analyzed.

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.

Time frame: At C1D8

Population: SAF

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.

Time frame: At C2D1

Population: SAF with available data analyzed.

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.

Time frame: At C2D15

Population: SAF with available data analyzed.

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.

Time frame: At C2D2

Population: SAF with available data analyzed.

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.

Time frame: At C2D22

Population: SAF with available data analyzed.

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.

Time frame: At C2D8

Population: SAF with available data analyzed.

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.

Time frame: At C3D1

Population: SAF with available data analyzed.

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.

Time frame: At C3D15

Population: SAF with available data analyzed.

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.

Time frame: At C3D22

Population: SAF with available data analyzed.

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.

Time frame: At C3D8

Population: SAF with available data analyzed.

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.

Time frame: At C4D1

Population: SAF with available data analyzed.

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.

Time frame: At C4D15

Population: SAF with available data analyzed.

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.

Time frame: At C4D22

Population: SAF with available data analyzed.

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.

Time frame: At C4D8

Population: SAF with available data analyzed.

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.

Time frame: At C5D1

Population: SAF with available data analyzed.

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.

Time frame: At C5D15

Population: SAF with available data analyzed.

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.

Time frame: At C6D1

Population: SAF with available data analyzed.

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.

Time frame: At C6D15

Population: SAF with available data analyzed.

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.

Time frame: At CID15

Population: SAF with available data analyzed.

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.

Time frame: At CID22

Population: SAF with available data analyzed.

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. EOT visit was 7 days after last dose.

Time frame: At EOT visit (day 175)

Population: SAF with available data analyzed.

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.

Time frame: At 30 days safety follow up (day 198)

Population: SAF with available data analyzed.

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.

Time frame: At 60 days safety follow up (day 228)

Population: SAF with available data analyzed.

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.

Time frame: At 90 days safety follow up (day 258)

Population: SAF with available data analyzed.

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.

Time frame: From first dose up to 198 days

Population: SAF

iORR was defined as the percentage of participants for each dose level whose best overall response is rated as complete response (iCR) or partial response (iPR) per iRECIST. iORR assessments included: * iORR with confirmed response * iORR with unconfirmed response iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 millimeter (mm) in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Time frame: From first dose up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for endpoints that were assessed by independent central review, thus data was not reported.

The dose recommended for use in phase 2 studies was analyzed on the basis of the safety, tolerability, and preliminary pharmacokinetic (PK) and efficacy data obtained in phase 1 studies.

Time frame: C1D1 up to C1D28

Population: SAF

iDCR was defined as the percentage of participants for each dose level whose best overall response is rated as confirmed and unconfirmed iCR, iPR or stable disease (iSD) per iRECIST. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. SD was defined as neither sufficient shrinkage to qualify for iPR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.

Time frame: From first dose up to 525 days

Population: RAS

DCR is defined as the percentage of participants for each dose level whose best overall response is rated as confirmed CR, PR or SD per RECIST v1.1.CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters (e.g. percent change from baseline). SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Time frame: From first dose up to 525 days

Population: RAS

OS is defined as the time from the date of first dose until the date of death from any cause (death date - first dose date + 1). For a participant who is not known to have died by the end of study follow-up, OS is censored at the date of last contact (date of last contact - first dose date + 1).

Time frame: From first dose up to 525 days

Population: FAS. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.

iDOR as per iRECIST was defined as the time from the date of the first response iCR/iPR (whichever is first recorded) to the date of radiographical progression or date of censoring. iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Time frame: From first response up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for this endpoint, thus data was not reported.

DOR as per RECIST 1.1 was defined as the time from the date of the first response CR/PR (whichever is first recorded) to the date of radiographical progression or date of censoring. CR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Time frame: From first response up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for this endpoint, thus data was not reported.

iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by investigator assessment. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Time frame: From first dose up to 525 days

Population: FAS with available data analyzed. The dose level utilized during the expansion phase was the recommended phase 2 dose (RP2D), which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness

ORR was defined as the percentage of participants for each dose level whose best overall response is rated as CR or PR per RECIST v1.1. ORR assessment included: ORR with confirmed response ORR with unconfirmed response Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response. CR was defined as disappearance of all target and non-target lesions and any pathological lymph nodes must be \<10 mm in the short axis. PR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters.

Time frame: From first dose up to 525 days

Population: Response Analysis Set (RAS): The response analysis consisted of all participants who were enrolled and received at least one dose of IP and had at least one post baseline primary efficacy measurement.

iORR was defined as the percentage of participants for each dose level whose best overall response is rated as iCR or iPR per iRECIST. iORR assessments included: * iORR with confirmed response * iORR with unconfirmed response iCR was defined as disappearance of all target and non target lesions and any pathological lymph nodes must be \<10 mm in the short axis. iPR was defined as at least a 30% decrease in the sum of the diameters of target lesions, taking as a reference, the baseline sum of the diameters. Participants who had CR or PR were considered to have confirmed response, and participants who did not meet this criterion were considered to have unconfirmed response.

Time frame: From first dose up to 525 days

Population: RAS

iPFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per iRECIST by independent central review. Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started.

Time frame: From first dose up to 525 days

Population: Due to early termination of the study, sponsor decided not to collect data for endpoints that were assessed by independent central review, thus data was not reported.

PFS is defined as the time from the date of first dose until death from any cause or radiographic disease progression assessed per RECIST v1.1 by investigator assessment.Progressive Disease was defined as at least a 20% increase in the sum of the diameters of target lesions, taking as a reference, the smallest sum of diameters recorded since the treatment started

Time frame: From first dose up to 525 days

Population: FAS with available data analyzed. The dose level utilized during the expansion phase was the RP2D, which was carefully selected from the dose escalation phase and a pooled population was used to estimate time-to-event efficacy endpoints for a comprehensive overview of the treatment's effectiveness.