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New treatment option for Solid Tumor
Official title A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
ClinicalTrials.gov ID: NCT07094204
What this study is testing
What is ASP5834?
ASP5834 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for solid tumor.
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
- Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
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 histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy with a documented Kirsten rat sarcoma...
- For a participant with a documented KRAS amplification, only those with no other co-occurring KRAS mutation or those with a co-occurring KRAS G12V...
- Unique to Europe (EU): Only participants who have pre-existing local results can be enrolled.
- For the ASP5834 monotherapy dose escalation part, participant with any histologically confirmed locally advanced (unresectable) or metastatic solid...
- For the ASP5834 monotherapy dose expansion part, the following criteria apply:
You likely can't join if
- AND there is agreement to allow by both the investigator and sponsor.
- Participant has adequate organ function as indicated by laboratory values (if a participant has received a recent blood transfusion, the laboratory...
- 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 has a negative urine or serum pregnancy test within 7 days prior to day 1 and agrees to follow the contraceptive guidance from the time of...
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 6 months after...
See the full eligibility criteria
Who can join
- Participant has histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy with a documented Kirsten rat sarcoma viral oncogene homolog (KRAS) G12V, G12D, G12C, G12R, G12A or G13D...
- For a participant with a documented KRAS amplification, only those with no other co-occurring KRAS mutation or those with a co-occurring KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation are eligible.
- Unique to Europe (EU): Only participants who have pre-existing local results can be enrolled.
- For the ASP5834 monotherapy dose escalation part, participant with any histologically confirmed locally advanced (unresectable) or metastatic solid tumor malignancy is eligible. Participant must have received prior...
- For the ASP5834 monotherapy dose expansion part, the following criteria apply:
- [pancreatic ductal adenocarcinoma (PDAC) Expansion Cohort(s)] Participant has histologically confirmed locally advanced (unresectable) or metastatic PDAC.
- [PDAC Expansion Cohort(s)] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation determined by local testing.
- [PDAC Expansion Cohort(s)] Participant must have received standard therapy in the advanced setting, including prior therapy with a gemcitabine-based or fluoropyrimidine-based regimen or is ineligible for these therapies.
- [PDAC Expansion Cohort(s)] No more than 2 prior lines of systemic therapy are allowed in the advanced setting (note: maintenance therapy does not count as a separate line of therapy).
- [PDAC Expansion Cohort(s)] For a participant who received prior neoadjuvant or adjuvant chemotherapy and had recurrence on or within 6 months of completion of therapy, the neoadjuvant or adjuvant chemotherapy should be...
- [non-small cell lung cancer (NSCLC) Expansion Cohort(s)] Participant has histologically confirmed locally advanced (unresectable) or metastatic NSCLC.
- [NSCLC Expansion Cohort(s)] Participant has a documented KRAS G12V, G12D, G12R, G12A or G13D mutation determined by local testing.
- [NSCLC Expansion Cohort(s)] Participant must have received standard therapy in the advanced setting, including prior platinum-based chemotherapy and checkpoint inhibitor therapy or is ineligible for these therapies...
- [NSCLC Expansion Cohort(s)] For a participant who has received prior neoadjuvant or adjuvant therapy and had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant therapy should be...
- [NSCLC Expansion Cohort(s)] For a participant with a history of unresectable Stage III disease who received prior multi-modal therapy and had recurrence on or within 6 months of completion of therapy, the multi-modal...
- [Other Solid Tumor Expansion Cohort] Participant has a histologically confirmed locally advanced (unresectable) or metastatic solid tumor type other than PDAC, colorectal cancer (CRC) or NSCLC.
- [Other Solid Tumor Expansion Cohort] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification (copy number \>/=4) determined by local testing.
- [Other Solid Tumor Expansion Cohort] Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or is...
- For ASP5834 combination therapy dose escalation and dose expansion parts, the following criteria apply:
- [CRC Dose Escalation and Dose Expansion Parts] Participant has histologically confirmed locally advanced (unresectable) or metastatic adenocarcinoma of the colon or rectum.
- [CRC Dose Escalation and Dose Expansion Parts] Participant has a documented KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation determined by local testing.
- [CRC Dose Escalation and Dose Expansion Parts] Participant must have received standard therapy in the advanced setting, including prior therapy with fluoropyrimidine, oxaliplatin and irinotecan and anti-vascular...
- [CRC Dose Escalation and Dose Expansion Parts] For a participant who has received neoadjuvant or adjuvant chemotherapy and had recurrence during or within 6 months of completion of therapy, the neoadjuvant or adjuvant...
- [CRC Dose Escalation and Dose Expansion Parts] Participant with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (CRC) must have also received prior treatment with immune...
- Participant consents to provide tumor specimen in a tissue block or unstained serial slides or a baseline tumor biopsy obtained after the last treatment treatment, but not more than 90 days prior to the 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 Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Participant's adverse event (AEs) (excluding alopecia) from prior anti-cancer therapy have improved to Grade 1 or baseline at least 14 days prior to the start of study intervention. Persistent Grade 2 or higher...
What rules you out
- AND there is agreement to allow by both the investigator and sponsor.
- Participant has adequate organ function as indicated by laboratory values (if a participant has received a recent blood transfusion, the laboratory tests must be obtained \>/= 14 days after any blood transfusion).
- 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 has a negative urine or serum pregnancy test within 7 days prior to day 1 and agrees to follow the contraceptive guidance from the time of informed consent through at least 6 months after final investigational...
- Female participant must not be breastfeeding or lactating starting at screening and throughout the investigational period and for 6 months after final investigational study intervention administration.
- Female participant must not donate ova starting at first administration of study intervention and throughout the investigational period and for 6 months after final investigational study intervention administration.
- Male participant must agree to use contraception with female partner(s) of childbearing potential (including breastfeeding partner) throughout the treatment period and for 3 months after final investigational study...
- Male participant must agree to remain abstinent or use a condom with pregnant partner(s) for the duration of the pregnancy throughout the investigational period and for 3 months after final investigational study...
- Male participant must not donate sperm during the treatment period and for 3 months after final investigational study intervention administration.
- Participant agrees not to participate in another treatment study while receiving study intervention in the present study/participating in the present study. Exclusion Criteria:
- Participant has symptomatic or untreated central nervous system (CNS) metastases. Participants with stable, asymptomatic and treated CNS metastases are eligible.
- Participant has leptomeningeal disease as a manifestation of the current malignancy.
- Participant has another prior malignancy active (i.e., requiring treatment or intervention) within the previous 2 years different from the primary malignancy for this study, except for local malignancies that have been...
- 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 with Acquired Immune Deficiency Syndrome (AIDS) related complications. No HIV testing is required unless mandated by a local health...
- 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...
- Resting heart rate \< 50 bpm at screening, unless clinically appropriate (e.g., well-conditioned participant) and deemed not clinically significant.
- Known family history of sudden cardiac death before 50 years of age.
- Hypokalemia that is not corrected to within the institutional normal range prior to first dose of study intervention.
- Participants with clinically significant electrolyte abnormalities (e.g., hypomagnesemia or hypocalcemia) that are not corrected to within the institutional normal range prior to first dose of study intervention.
- Participant has had major surgery within 4 weeks prior to first dose of study intervention.
- Participant has acute neurological events (e.g., intracranial or subarachnoid hemorrhage, stroke, intracranial trauma) within 6 months prior to the first dose of study intervention.
- Participant has received any radiotherapy (including stereotactic radiosurgery) within 14 days prior to the first dose of study intervention.
- Participant has received prior KRAS targeting agents (including but not limited to KRAS directed inhibitors, degraders, small interfering RNA [siRNA] therapies, vaccines and cellular therapies), with the following...
- In the dose escalation part, a participant with PDAC or NSCLC who has received prior RMC-6236 or RMC-9805 or a participant with NSCLC who has received prior KRAS G12C inhibitors but no other KRAS targeting agents will...
- Participant has an active infection requiring any systemic anti-infectious agents within 14 days prior to study intervention.
- Participant is expected to require another form of anticancer therapy while on study treatment.
- Participant requires treatment with concomitant drugs that are strong or moderate inhibitors or inducers of Cytochrome P450 family 3 subfamily A (CYP3A).
- Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening.
- Participant has any condition that makes the participant unsuitable for study participation.
- Participant has a known or suspected hypersensitivity to the protocol specified study intervention(s) or any components of the formulation used.
- Participant has a corrected QT interval by Fridericia (QTcF) value (single electrocardiogram (ECG)) of \> 450 msec (men) or \> 470 msec (women) during screening.
- Participant has a left ventricular ejection fraction (LVEF) \< 50% as assessed by echocardiogram (ECHO) (or multigated acquisition (MUGA)) performed at screening.
- Participant with a known history of an acquired KRAS G12V, G12D, G12C, G12R, G12A or G13D mutation or KRAS amplification identified as a resistance mechanism to prior systemic therapy (note: if a participant has more...
- UNIQUE to EU: Participant who is the subject of any legal protection measures under local legislation will not be allowed.
- Participant has a history of pneumonitis/interstitial lung disease (ILD) or has current pneumonitis/ILD. Note that a participant with resolved pulmonary infections is eligible.
- [ASP5834 combination therapy] Participant had prior discontinuation of panitumumab treatment due to toxicity or intolerance of panitumumab.
The study team makes the final eligibility decision.
Where it's taking place
- Santa Monica, California, United States
- Atlanta, Georgia, United States
- Jefferson, Louisiana, United States
- Grand Rapids, Michigan, United States
- St Louis, Missouri, United States
- Hackensack, New Jersey, United States
- Buffalo, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Irving, Texas, United States
- Fairfax, Virginia, United States
- Bordeaux, New Aquitaine, France
- Lyon, France
- Pierre-Bénite, France
- Villejuif, France
- Hirakata, Osaka, Japan
- Koto-ku, Tokyo, Japan
- Barcelona, Catalonia, Spain
- Madrid, Spain
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 study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Santa Monica, California, United States; Atlanta, Georgia, United States; Jefferson, Louisiana, United States; Grand Rapids, Michigan, United States; St Louis, Missouri, United States; Hackensack, New Jersey, United States and 13 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.