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New treatment option for Solid Tumor
Official title A Study of ASP3082 in Adults With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05382559
What this study is testing
What is Setidegrasib?
Setidegrasib is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
Also referred to as ASP3082.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is an open-label study. This means that people in this study and clinic staff will know that people will receive ASP3082.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog...
- For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled. Participants with other known...
- For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX or NALRIFOX: Participant must have mPDAC that has not been previously treated with...
- Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision)...
- Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously...
You likely can't join if
- Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to start of study intervention.
- Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic, treated CNS metastases are eligible.
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years, except for local malignancies that...
- Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
- Participant with active hepatitis B (including acute hepatitis B virus [HBV] or chronic HBV) or hepatitis C virus [HCV] (ribonucleic acid [RNA]...
See the full eligibility criteria
Who can join
- Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented Kirsten rat sarcoma viral oncogene homolog [KRAS] G12D mutation and has received prior standard therapy and the...
- For the ASP3082 monotherapy escalation cohorts, participants with solid tumor malignancies are allowed to be enrolled. Participants with other known KRAS G12 mutations will not be eligible for the study
- For ASP3082 combination therapy with Nab-P+GEM or FOLFIRINOX or NALRIFOX: Participant must have mPDAC that has not been previously treated with chemotherapy. If a participant received (neo)adjuvant therapy, tumor...
- Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a tumor biopsy (core needle biopsy or excision) obtained after the last treatment treatment, but prior to start of study...
- Participant has at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been...
- Participant has an ECOG performance status of 0, 1 or 2 for dose escalation, and 0 or 1 for dose expansion.
- Participant's last dose of prior antineoplastic therapy, including any immunotherapy, was 21 days or 5 half-lives, whichever is shorter, prior to initiation of study intervention administration.
- Participant has completed any radiotherapy (including stereotactic radiosurgery) at least 14 days prior to the start of study intervention administration. Participants must have recovered from all radiation-related...
- Participant's adverse events [AEs] (excluding alopecia) from prior therapy have improved to grade 1 or baseline within 14 days prior to start of study intervention (or prior to staring SoC chemotherapy, for first line...
- Participant has adequate organ function as indicated by protocol laboratory value parameters (If a participant has received a recent blood transfusion, the laboratory tests must be obtained \>= 14 days after any blood...
- Female participant is not pregnant, confirmed by pregnancy test and medical evaluation by interview, and at least 1 of the following conditions apply:
- Not a woman of childbearing potential (WOCBP).
- WOCBP who agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after study intervention administration.
- EU only: For combination therapy with carboplatin, follow contraception guidelines from the time of informed consent through at least 7 months after the final dose of carboplatin.
- South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 15 months after the final dose of oxaliplatin. For combination therapy with...
- Female participant must agree not to breastfeed starting at screening and throughout the study period and for 6 months after study intervention administration.
- Female participant must not donate ova starting at first dose of study intervention and throughout the study period and for 6 months after 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 3 months after study intervention...
- Male participant must not donate sperm during the treatment period and for 3 months after study intervention administration.
- South Korea only: For combination therapy with oxaliplatin, follow contraception guidelines from the time of informed consent through at least 12 months after the final dose of oxaliplatin. For combination therapy with...
- 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 3 months after study intervention administration.
- Participant agrees not to participate in another treatment study while receiving study intervention (Participants who are currently in the follow-up period of an treatment clinical trial are allowed).
- For ASP3082 Combination Therapy with Pembrolizumab (Cohort G), or Platinum-based Chemotherapy + Pemetrexed +/- Pembrolizumab (Cohort H): Participant must have pathologically documented locally advanced or metastatic...
- have received prior platinum-containing chemotherapy (safety lead-in only) or
- have never received systemic therapy (up to 1 cycle of SoC pembrolizumab [defined as one 21-day cycle of 200 mg] in Cohort G and up to 1 cycle of SoC platinum-based chemotherapy ± pembrolizumab [defined as one 21-day...
What rules you out
- Participant has received investigational therapy within 21 days or 5 half-lives, whichever is shorter, prior to start of study intervention.
- Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with asymptomatic, treated CNS metastases are eligible.
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has a prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years, except for local malignancies that have been apparently cured, such as basal or squamous cell skin...
- Participant has a known or suspected hypersensitivity to ASP3082 or any components of the formulation used.
- Participant with active hepatitis B (including acute hepatitis B virus [HBV] or chronic HBV) or hepatitis C virus [HCV] (ribonucleic acid [RNA] detected by qualitative assay). HCV RNA testing is not required in...
- Participant has a known history of human immunodeficiency virus [HIV] infection. No HIV testing is required unless mandated by a local health authority.
- Participant has had a myocardial infarction or unstable angina within 6 months prior to the start of study intervention, left ventricular ejection fraction (LVEF) \< 50% as determined by multigated acquisition (MUGA)...
- Participant has a corrected QT interval (single electrocardiogram [ECG]) using Fridericia's formula (QTcF) \> 450 milliseconds (msec) (men) or \>470 msec (women) during screening.
- Participant has received prior treatment with a specific KRAS G12D inhibitor/degrader or pan-RAS inhibitor/degrader targeting KRAS G12D. Participants who received prior treatment with a KRAS G12D inhibitor/degrader are...
- Participant has an active infection requiring intravenous antibiotics within 14 days prior to study intervention.
- Participant is expected to require another form of antineoplastic therapy while on study treatment.
- Participant has any condition which makes the participant unsuitable for study participation (such as psychiatric illness/social situations that would limit compliance with study requirements).
- Participant has had major surgery within 4 weeks prior to first dose of study intervention. For ASP3082 Combination Therapy:
- Prior discontinuation of cetuximab treatment due to toxicity or intolerance of cetuximab.
- History of interstitial lung disease requiring systemic steroid treatment. Note that a participant with resolved pulmonary infections or radiation pneumonitis is eligible.
The study team makes the final eligibility decision.
Where it's taking place
- Duarte, California, United States
- Santa Monica, California, United States
- Denver, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Gainesville, Florida, United States
- Lake Mary, Florida, United States
- Sarasota, Florida, United States
- Westwood, Kansas, United States
- Boston, Massachusetts, United States
- Ypsilanti, Michigan, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Cleveland, Ohio, United States
- Maumee, Ohio, United States
- Portland, Oregon, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
+ 36 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Duarte, California, United States; Santa Monica, California, United States; Denver, Colorado, United States; New Haven, Connecticut, United States; Washington D.C., District of Columbia, United States; Gainesville, Florida, United States and 50 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.