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โ† Trials
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A Study of ASP1002 in Adults for Treatment of Solid Tumors

RecruitingPhase 1Ages 18 Years - anyAllAstellas Pharma Global Development, Inc.
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In plain words

What the trial is, and whether it could suit you

ASP1002 is being studied in people with tumors that have spread to nearby tissue (locally advanced) that cannot be removed by surgery (unresectable) or tumors that have spread to other parts of the body (metastatic). Claudin 4 protein, or CLDN4, is a protein found on tumors in different parts of the body. ASP1002 is thought to work by attaching to the CLDN4 protein in the tumor. This switches on the body's immune system to attack the tumor. Before ASP1002 can be used, researchers need to collect information about the safety of ASP1002 and how people with tumors tolerate it. In this study, ASP1002 will be given to humans for the first time. It will either be given by itself or together with other cancer treatments. These include standard chemotherapies (mFOLFOX6, FOLFIRI, TAS-102, pemetrexed, carboplatin, and docetaxel) and immunotherapies (bevacizumab, pembrolizumab, and ramucirumab). I

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria For Monotherapy: * Participant has locally-advanced (unresectable or metastatic solid tumor) confirmed by available pathology records or current biopsy. a. For monotherapy dose escalation, participant must have one of the following malignancies:NSCLC-adenocarcinoma, squamous cell carcinoma and adenosquamous are included; large cell carcinoma and sarcomatoid carcinoma are excluded, UC, CRC, prostate adenocarcinoma, epithelial ovarian cancer (including fallopian tube cancer) and triple-negative breast cancer (TNBC). * TNBC defined as unequivocal TNBC histology (ER 1 negative/progesterone receptor-negative/HER2-negative). This is defined by \< 1% expression of ER and progesterone receptor by IHC and that are, for HER2, either 0 to 1+ by IHC, or IHC 2+ and FISH negative (not amplified) as per current ASCO/CAP guidelines \[Hammond et al, 2010\]. b. For tumor-specific monotherapy dose expansion, participant must have one of the following malignancies mCRC, mAPMR-PCa and tumor type for which a confirmed response was observed during dose escalation. * Monotherapy expansion mCRC/mAPMR-PCa cohort: Participants with MSS/MSI-L mCRC/mAPMR-PCa, are eligible. * Monotherapy expansion select CLDN4-expressing tumors cohort: Participants with metastatic solid tumors known to highly express CLDN4 are eligible. * Participant has progressed, is intolerant, has refused, or there are no approved therapies that impart significant clinical benefit (no limit to the number of prior treatment regimens). * Female participant is not pregnant, confirmed by pregnancy test (and medical evaluation by interview 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 ASP1002 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 at the date of consent) from either the primary tumor or a metastatic site, with source and availability confirmed prior to Cycle 1 Day 1 (C1D1); participants without available tissue should undergo a mandatory biopsy. 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. * Eastern Cooperative Oncology Group (ECOG) Status of 0 or 1 within 7 days before the first dose of study drug. * Participants who received radiotherapy must have completed it 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. In case of recent blood transfusion, laboratory tests must be obtained \>/=2 weeks post transfusion. * Female participants must not breastfeed from screening through 90 days post-final dose and must not donate ova from first dose through 90 days post-final dose. * Male participants with WOCBP partners must use contraception during treatment and for 90 days post-final dose. * Male participants must not donate sperm during treatment and for 90 days post-final dose, and those with pregnant partners must remain abstinent or use condoms for the duration of the pregnancy and 90 days post-final dose. * Participant agrees not to participate in another interventional study while receiving any study intervention in the present study. For Combination-therapy: * Participant has accessible archival tumor tissue (\< 6 months old at the date of consent) from either the primary tumor or a metastatic site, for which source and availability have been confirmed prior to C1D1. Participant should undergo a tumor biopsy during the treatment period as indicated in the schedules of assessments. * 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. * ECOG Status of 0 or 1 within 7 days before the first dose of study drug. * Participant has adequate organ function prior to start of study intervention as indicated by laboratory values. If a participant has received a recent blood transfusion, the laboratory tests must be obtained โ‰ฅ 2 weeks after any blood transfusion. * Female participant is not pregnant as confirmed by pregnancy test, not breastfeeding and must not donate ova starting at first administration of study intervention and for at least 9 months after final study intervention administration * Not a WOCBP * WOCBP must adhere to required contraception from informed consent through 9 months post-final study intervention. * Male participant must not donate sperm during the treatment period and for at least 6 months after final study intervention administration. Combination-specific Inclusion Criteria for MSS-mCRC (2L) ASP1002 + bevacizumab + mFOLFOX6 * Participant has MSS-mCRC which is confirmed by available pathology records or current biopsy. Participant is AGA-negative and HER2-negative. * Participant has progressed or is intolerant to 1L irinotecan-based therapy for their metastatic disease. Participant is eligible to receive mFOLFOX6 and bevacizumab. * WOCBP must adhere to required contraception from informed co
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What it tests

  • ASP1002
  • Bevacizumab
  • Oxaliplatin
  • Leucovorin
  • Fluorouracil
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Where

15 sites
Yale University Cancer Center
New Haven, United States
Hartford HealthCare Cancer Institute at The Hospital of Central Connecticut
Plainville, United States
University of Florida
Gainesville, United States
University of Iowa Hospitals
Iowa City, United States
Norton Cancer Institute
Louisville, United States
Henry Ford Hospital
Detroit, United States
HealthPartners Cancer Research Center
Saint Paul, United States
Icahn School of Medicine at Mount Sinai
New York, United States

โ€ฆand 7 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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