MC# 21-41 - A Phase I Study of ASP1570 in Participants with Advanced Solid Tumors
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Agent(s): ASP1570
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Disease Type(s): Solid Tumor
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Phase(s): I
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Drug Classification(s): Immunotherapy, Targeted Therapy
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Molecular Target(s): DAG (DGK)
Mechanism of Action
ASP1570 is a small molecule immuno-oncology agent that is expected to act through the activation of immune cells in the tumor microenvironment.
Purpose
In this study, the sponsor and investigators want to learn:
- How much of ASP1570 can be given with an acceptable level of side effects
- The effects of ASP1570 (good and bad)
- How much of ASP1570 is absorbed into the blood and how fast it is removed
- If ASP1570 prevents or slows tumor growth or shrinks existing tumors
Inclusion Criteria
- Participant is considered an adult according to local regulations at the time of signing ICF
- Participant has locally-advanced (unresectable) or metastatic solid tumor malignancy, which is confirmed by available pathology records or current biopsy
- Participant has at least 1 measureable lesion per RECIST v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
- Participant that has progressed after receiving all standard approved therapies or is no longer eligible for standard therapy (no limit to the number of prior treatment regimens)
- Participant has an ECOG status of 0, 1 or 2
- Participant’s last dose of prior antineoplastic therapy, including any immunotherapy, was at least 21 days prior to the first dose of IP. A participant with EGFR or ALK mutation-positive NSCLC is allowed to remain on EGFR TKI or ALK inhibitor therapy until 4 days prior to the first dose of IP
- Participants who have received radiotherapy must have completed this therapy (including stereotactic radiosurgery) at least 2 weeks prior to the first dose of IP
- Participant’s AEs (excluding alopecia) from prior therapy have improved to grade 1 or baseline at least 14 days prior to the first dose of IP. Note: Participants 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 adequate organ function prior to start of study treatment
- Participant has activated partial thromboplastin time and INR ≤ 1.5 x ULN and is not receiving anticoagulation
- Female participant is not pregnant and at least one of the following conditions apply:
- Not a WOCBP
- WOCBP who agrees to follow the contraceptive guidance from time of informed consent through at least 45 days after final IP administration
- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 45 days after final IP administration
- Female participant must not donate ova starting at first dose of IP and throughout the study period and for 45 days after final IP administration
- Male participant with female partner(s) of childbearing potential (including breastfeeding partner) must agree to use contraception throughout the treatment period and for 45 days after final IP administration
- Male participant must not donate sperm during the treatment period and for 45 days after final IP 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 45 days after final IP administration
- Participant agrees not to participate in another interventional study while receiving study treatment in the present study
Exclusion Criteria
- Participant has received investigational therapy (other than an investigational EGFR TKI in a participant with EGFR activating mutations or ALK inhibitor in a participant with an ALK mutation) within 21 days or 5 half-lives, whichever is shorter, prior to the first dose of IP
- Participant requires or has received systemic steroid therapy or any other immunosuppressive therapy within 14 days prior to the first dose of IP. Participants using a physiologic replacement dose of hydrocortisone or its equivalent (defined as up to 30 mg per day of hydrocortisone and up to 10 mg prednisone) are allowed.
- Participant has received and requires strong or moderate CYP2D6 inhibitors (e.g., bupropion, fluoxetine, paroxetine, duloxetine, abiraterone) during the study
- Participant has symptomatic CNS metastases or participant has evidence of unstable CNS metastases 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 treatment and are not requiring immunosuppressive doses of systemic steroids (> 30 mg per day of hydrocortisone or > 10 mg per day of prednisone or equivalent) for no longer than 2 weeks.
- Participant has an active autoimmune disease. Participants 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 was discontinued from prior immunomodulatory therapy due to a grade ≥ 3 toxicity that was mechanistically related (e.g., immune-related) to the agent in the judgment of the investigator
- Participant has a known history of HIV infection. HIV testing is not required for the purposes of this study unless mandated by local health authority
- Participant has any of the following per screening serology test:
- Hepatitis A virus (HAV) antibodies (immunoglobulin M [IgM])
- Positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B DNA. Participants with negative HBsAg, positive hepatitis B core antibody (anti-HBc) and negative hepatitis B surface antibody (anti-HBs) are eligible if hepatitis B DNA is undetectable.
- Hepatitis C virus (HCV) antibodies unless HCV RNA is undetectable.
- Participant has received a live vaccine against infectious diseases within 28 days prior to first dose of IP
- Participant has a history of drug-induced pneumonitis (interstitial lung disease [ILD]), currently has pneumonitis or a prior history of ILD or noninfectious pneumonitis requiring high-dose glucocorticoids whether resolved or not
- Participant has an infection requiring systemic therapy within 14 days prior to the first dose of IP
- Participant has received a prior allogeneic bone marrow or solid organ transplant
- Participant is expected to require another form of antineoplastic therapy while on study treatment
- Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study treatment or currently has an uncontrolled illness including, but not limited to symptomatic congestive heart failure, clinically significant cardiac disease, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements
- Participant has inadequately controlled hypertension (defined as systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
- Participant has a corrected QT interval (single ECG) using Fridericia’s formula (QTcF) > 450 msec (for male and female participants) during screening. ECGs will be performed in triplicate during screening
- Participant has a prior malignancy, other than the current malignancy for which the participant is seeking treatment, active (i.e., requiring treatment or intervention) within the previous 2 years except for locally curable malignancies that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix or breast
- Participant has had a major surgical procedure and has not completely recovered within 28 days prior to first dose of IP
- Participant has a history of bleeding diathesis
- Participant requires use of any anticoagulation therapy
- Participant has any condition, which, in the investigator’s opinion, makes the participant unsuitable for study participation
- Participant has a known or suspected hypersensitivity to ASP1570, or any components of the formulation used
Location
- Dallas, TX - Mary Crowley Cancer Research - Medical City
