Trial Title:
A Study of ASP1002 in Adults for Treatment of Solid Tumors
NCT ID:
NCT05719558
Condition:
Advanced Solid Tumors
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumor;
Malignancy;
Metastasis;
cancer;
ASP1002;
Pharmacokinetics
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ASP1002
Description:
intravenous (IV) infusion
Arm group label:
ASP1002 Dose Escalation (Part 1)
Arm group label:
ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)
Arm group label:
Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)
Arm group label:
Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)
Summary:
ASP1002 is a potential new treatment for people with certain solid tumors. Before ASP1002
is available as a treatment, the researchers need to understand how it is processed by
and acts upon the body. This information will help find a suitable dose and check for
potential medical problems from the treatment.
People in this study will be adults with locally advanced or metastatic solid tumors with
high levels of a protein called claudin 4. Metastatic means the cancer has spread to
other parts of the body. They will have been previously treated with available standard
therapies or refused to receive those treatments.
There are 2 main aims of this study. One is to learn if people with certain solid tumors
have any medical problems or side effects after receiving different doses of ASP1002. The
other is to find a suitable dose of ASP1002 to use in future studies.
This study will be in 2 parts.
In Part 1, different small groups of people will receive lower to higher doses of
ASP1002. Any medical problems and side effects will be recorded at each dose. This is
done to find suitable doses of ASP1002 to use in Part 2 of the study. The first group
will receive the lowest dose of ASP1002. A medical expert panel will check the results
from this group and decide if the next group can receive a higher dose of ASP1002. The
panel will do this for each dose group until all groups have taken ASP1002 or until
suitable doses have been selected for Part 2.
In Part 2, other different small groups of people will receive ASP1002 with the most
suitable doses determined from Part 1. This will help find a more accurate dose of
ASP1002 to use in future studies.
During both parts of the study, ASP1002 will be given through a vein. This is called an
infusion. Each treatment cycle is 21 days long and the infusion is given weekly. People
in this study will continue treatment for up to 2 years (32 cycles) until: they have
medical problems or side effects that prevent them from continuing treatment; their
cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do
not come back for treatment.
People will visit the clinic several times during each treatment cycle. They will receive
ASP1002 infusions 3 times during each treatment cycle. Each infusion could take 15
minutes to 2 hours, depending on the dose. In addition to infusions, other checks will
occur during the visit. During these visits, the study doctors will check for any medical
problems and side effects from ASP1002. At some visits, other checks will include a
medical examination, laboratory tests and vital signs. Vital signs include temperature,
pulse, breathing rate, oxygen saturation, and blood pressure. Also, blood and urine
samples will be taken. Tumor samples will be taken during certain visits during treatment
and when treatment has finished.
People will visit the clinic within 7 days after stopping treatment. The study doctors
will check for any medical problems and side effects from ASP1002. Other checks will
include a medical examination, laboratory tests and vital signs. Then, they may visit the
clinic at 30 days (1 month) and 90 days (3 months) after stopping treatment. At the
30-day visit, the study doctors will check for any medical problems and side effects from
ASP1002. People will have their vital signs checked and have some laboratory tests. At
the 90-day visit, the study doctors will check for any medical problems and side effects
from ASP1002 and people will have their vital signs checked. After this, people will
continue to visit the clinic every 9 to 12 weeks. This is to check the condition of their
cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Participant has locally-advanced (unresectable) or metastatic solid tumor which is
confirmed by available pathology records or current biopsy.
- For dose escalation, the participant must have one of the following
malignancies (for all tumor types, any component of neuroendocrine histology is
exclusionary): a. NSCLC - adenocarcinoma, squamous cell carcinoma and
adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are
excluded. Note: NSCLC Not Otherwise Specified will require medical monitor
consultation prior to study entry; b. urothelial carcinoma (UC); c. colorectal
cancer (CRC); d. Prostate adenocarcinoma; e. Ovarian cancer; f. triple-negative
breast cancer (TNBC): TNBC defined as unequivocal TNBC histology (estrogen
receptor-1 (ER-1) negative/progesterone receptor-negative/ human epidermal
growth factor receptor (HER2)-negative). This is defined by < 1% expression of
ER and progesterone receptor by immunohistochemistry (IHC) and that are, for
HER2, either 0 to 1+ by IHC, or IHC 2+ and fluorescence in situ hybridization
(FISH) negative (not amplified) as per current American Society of Clinical
Oncology (ASCO)/ College of American Pathologists (CAP) guidelines [Hammond et
al, 2010].
- For dose expansion, the participant must have one of the following malignancies
(for all tumor types, any component of neuroendocrine histology is not
eligible): a. NSCLC - adenocarcinoma, squamous cell carcinoma and adenosquamous
are included; large cell carcinoma and sarcomatoid carcinoma are excluded.
Note: NSCLC Not Otherwise Specified will require medical monitor consultation
prior to study entry; b. UC; c. CRC; d. Tumor type for which a confirmed
response was observed during dose escalation.
- 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.
Exclusion Criteria:
- 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 untreated or active central nervous system (CNS) metastases.
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)
- b. Positive hepatitis B surface antigen (HBsAg) or detectable hepatitis B
Deoxyribonucleic Acid (DNA). Participant 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
- c. hepatitis C virus (HCV) antibodies unless HCV Ribonucleic acid (RNA) is
undetectable
- Participant has a history of drug-induced pneumonitis, interstitial lung disease
(ILD), currently has pneumonitis, or a prior history of ILD or non-infectious
pneumonitis requiring high-dose glucocorticoids.
- Participant has an infection requiring intravenous antibiotics within 14 days prior
to study intervention administration.
- Participant has received a prior allogeneic bone marrow or solid organ transplant.
- Participant has had a major surgical procedure and has not completely recovered
within 28 days prior to the start of study intervention.
- Participant with recent positive antigen test for Coronavirus Disease 2019
(COVID-19) within 10 days prior to study intervention administration. Note:
Participants who are asymptomatic after 10 days from the first positive antigen test
may be enrolled.
- Participant has received any investigational therapy or antineoplastic therapy or
other immunotherapy within 21 days or 5 half-lives, whichever is shorter, prior to
the first dose of study intervention. Note: Participants with prostate
adenocarcinoma who do not have a bilateral orchiectomy should continue androgen
deprivation therapy (ADT) during the study. A participant with epidermal growth
factor receptor (EGFR), receptor tyrosine kinase (encoded by the gene ROS1), or
anaplastic lymphoma kinase (ALK) mutation-positive NSCLC is allowed to remain on
EGFR tyrosine receptor inhibitor, neurotrophic tyrosine receptor kinase inhibitor or
ALK inhibitor therapy until 4 days prior to the start of study intervention
administration.
- Participant requires or has received systemic steroid therapy or any other
immunosuppressive therapy within 14 days prior to ASP1002 administration.
Participants using a physiologic replacement dose of corticosteroids equivalent to
10 mg per day of prednisone or less are allowed, as is receiving a single dose of
systemic corticosteroids, or receiving systemic corticosteroids as premedication for
radiologic imaging contrast is eligible.
- Participant was discontinued from prior immunomodulatory therapy due to a grade >/=3
toxicity that was mechanistically related (e.g., immune-related) to the agent and
deemed life-threatening.
- Participant is expected to require another form of antineoplastic therapy while on
study intervention.
- Participant has another malignancy requiring active therapy; (other than those
indicated in Inclusion Criterion No. 1).
- Participants who have received prior anti-CD137 therapy.
- Participant has received a live vaccine against infectious diseases within 28 days
prior to initiation of study intervention.
- Participant has any condition makes the participant unsuitable for study
participation.
- Participant has a known or suspected hypersensitivity to ASP1002 or any components
of the formulation used.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Yale University Cancer Center
Address:
City:
New Haven
Zip:
06520
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Florida
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Iowa Hospitals
Address:
City:
Iowa City
Zip:
52242
Country:
United States
Status:
Recruiting
Facility:
Name:
Norton Cancer Institute
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Facility:
Name:
University Hospitals of Cleveland
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Facility:
Name:
Prisma Health-Upstate Cancer Institute
Address:
City:
Greenville
Zip:
29605
Country:
United States
Status:
Recruiting
Facility:
Name:
SCRI Oncology Partners
Address:
City:
Nashville
Zip:
37203
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Southwestern
Address:
City:
Dallas
Zip:
75235
Country:
United States
Status:
Recruiting
Facility:
Name:
Mary Crowley Cancer Research Center
Address:
City:
Dallas
Zip:
75251
Country:
United States
Status:
Recruiting
Facility:
Name:
NEXT Oncology Virginia
Address:
City:
Fairfax
Zip:
22031
Country:
United States
Status:
Recruiting
Start date:
March 13, 2023
Completion date:
May 31, 2028
Lead sponsor:
Agency:
Astellas Pharma Global Development, Inc.
Agency class:
Industry
Source:
Astellas Pharma Inc
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05719558
