A Study of ASP1002 in Adults for Treatment of Solid Tumors

Exclusion Criteria

• •I. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded. Note: NSCLC Not Otherwise Specified will require documented discussion with the medical monitor prior to study entry.
• •II. UC III. CRC IV. Tumor type for which a confirmed response was observed during dose escalation.
• •Female participant is not pregnant, confirmed by pregnancy test (and medical evaluation by interview \[UNIQUE to Japan\]), and at least 1 of the following conditions apply:
• •1. Not a woman of childbearing potential (WOCBP)
• •2. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 90 days after final study intervention administration.
• •Participant has progressed, is intolerant, has refused, or there are no standard approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens).
• •Participant has accessible archival tumor tissue (\< 6 months old) from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to study intervention; participants without available tissue should undergo a mandatory biopsy. If the participant is unable to undergo a biopsy due to safety concerns, enrollment into the study is at the discretion of the medical monitor. Participant should undergo a tumor biopsy during the treatment period as indicated in the schedule of assessments. Note: Tumor tissue collection (at screening/baseline and on-treatment) is optional for participants enrolled initially in dose levels 1 to 3 in dose escalation; however, protocol de-escalation and expansion of dose levels similar to dose levels 1 to 3 may require collection and processing of screening/baseline and on-treatment tumor samples.
• •Participant has at least 1 measurable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• •Participant has an Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1.
• •Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to study intervention administration.
• •Participant has predicted life expectancy \>/= 12 weeks.
• •Participant has adequate organ function prior to start of study intervention. If a participant has received a recent blood transfusion, the laboratory tests must be obtained \>/=2 weeks after any blood transfusion.
• •Female participant is not pregnant and at least 1 of the following conditions apply:
• •* a. Not a woman of childbearing potential (WOCBP)
• •* b. WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 90 days after final study intervention administration.
• •Female participant must agree not to breastfeed starting at screening and throughout the study period and for 90 days after final study intervention administration.
• •Female participant must not donate ova starting at first administration of study intervention and throughout 90 days after final study intervention administration.
• •Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 90 days after final study intervention administration.
• •Male participant must not donate sperm during the treatment period and for 90 days after final study intervention administration.
• •Male participant with pregnant partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy throughout the study period and for 90 days after final study intervention administration.
• •Participant agrees not to participate in another interventional study while receiving study intervention in the present study.
• •Participant weighs \< 40 kg.
• •Participant has ongoing toxicity \>/= grade 2 per the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 considered clinically significant and attributable to prior antineoplastic therapies.
• •Participant has symptomatic CNS metastases or evidence of uncontrolled CNS disease even if asymptomatic (e.g. progression on scans). Participants with previously treated CNS metastases are eligible, if they are clinically stable and have no evidence of CNS progression by imaging for at least 4 weeks prior to start of study intervention and are not requiring immunosuppressive doses of systemic steroids (equivalent to \> 10 mg per day of prednisone) for longer than 2 weeks.
• •Participant has an active autoimmune disease. Participant with type 1 diabetes mellitus, endocrinopathies stably maintained on appropriate replacement therapy, or skin disorders (e.g., vitiligo, psoriasis or alopecia) not requiring systemic treatment are allowed.
• •Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention or currently has an uncontrolled illness including, but not limited to, symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia, complete left bundle branch block, obligate use of a cardiac pacemaker, long QT syndrome or right bundle branch block with left anterior hemiblock (bifascicular block).
• •Participant has a corrected corrected QT interval (QTcF) interval (single electrocardiogram (ECG)) \> 470 ms within 7 days prior to the first study intervention administration on day 1.
• •Participant has left ventricular ejection fraction (LVEF) \< 45% noted in screening echocardiogram (ECHO). Any clinically significant findings from this ECHO should be discussed with the medical monitor.
• •Participant is known to have human immunodeficiency virus (HIV) infection. However, participants with HIV infection with CD4+ T cell counts \>/=350 cells/μL and no history of acquired immunodeficiency syndrome (AIDS)-defining opportunistic infections within the past 6 months are eligible. Note: No HIV testing is required at screening unless mandated per local requirements.
• •Participant has any of the following per screening serology test:
• •* a. Hepatitis A virus antibodies immunoglobulin (IgM)