BridgeMD
New treatment option for Cancer
Official title An Open-Label Study of INV-1120 as a Single Agent and in Combination With Pembrolizumab in Adult Patients With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT04443088
What this study is testing
What is INV-1120?
INV-1120 is an investigational medicine, being studied as a potential treatment for cancer.
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
- Phase 1, open-label dose-escalation study to determine the MTD of INV-1120 and RP2D, and to assess the DLT of INV-1120 as a single agent or in the combination with pembrolizumab. The safety, tolerability, and PK of INV-1120 as a single agent or in the combination with pembrolizumab will be assessed in adult patients with advanced solid tumors.
- 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
- Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures...
- Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF);
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
- Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no...
- Patients with life expectancy ≥3 months;
You likely can't join if
- History (≤5 years) or current evidence of cancer that is histologically distinct from the cancer under study, except for cervical carcinoma in situ...
- Known serious allergy to investigational drug or excipients (microcrystalline cellulose);
- History of severe autoimmune disease (including significant ongoing immune-related adverse events of prior immune-oncology therapy) or autoimmune...
- Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastases having been treated...
- History (within 4 weeks of starting treatment) or evidence of active infections (Grade ≥2);
- Seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at any time before the start of...
See the full eligibility criteria
Who can join
- Written informed consent, according to local guidelines, signed and dated by the patient prior to the performance of any study-specific procedures, sampling, or analyses;
- Patient must be ≥18 years-of-age at the time of signature of the informed consent form (ICF);
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
- Patients with histologically or cytologically confirmed advanced solid tumors which have progressed on or following standard therapy or for which no standard therapy exists;
- Patients with life expectancy ≥3 months;
- Patients with at least one measurable lesion by computed tomography (CT) or magnetic resonance imaging (MRI), according to RECIST v1.1. Tumor lesions that have been irradiated ≥4 weeks before the start of treatment, and...
- Patients whose laboratory data at screening meet the acceptable criteria for bone marrow, liver function and renal function.
- Women of childbearing potential (WOCBP) must have a negative urine pregnancy test during screening. A woman is considered of childbearing potential (fertile) following menarche and until becoming postmenopausal unless...
- Male patients with female partners of childbearing potential and female patients of childbearing potential are required to use two forms of acceptable contraception, including one barrier method, during their...
- Hormonal methods (Needs to have been instituted at least 1 month prior to the first dose of study drug):
- Barrier methods:
- Abstinence, defined as refraining from sexual intercourse
- Male patients must also refrain from donating sperm from the first dose of study drug until 4 months after the last dose of study drug;
- Patients must be able to swallow and retain orally administered medication.
What rules you out
- History (≤5 years) or current evidence of cancer that is histologically distinct from the cancer under study, except for cervical carcinoma in situ, superficial non-invasive bladder tumors, or curatively treated Stage I...
- Known serious allergy to investigational drug or excipients (microcrystalline cellulose);
- History of severe autoimmune disease (including significant ongoing immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at...
- Known malignant central nervous system disease other than neurologically stable, treated brain metastases - defined as metastases having been treated by surgery, surgery plus radiotherapy or radiotherapy alone, with no...
- History (within 4 weeks of starting treatment) or evidence of active infections (Grade ≥2);
- Seropositive status for human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) at any time before the start of treatment: Testing for seropositive status during screening will be at the...
- History or evidence of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study, such as any...
- History (≤6 months before the start of treatment) or evidence of any of the following: acute myocardial infarction, unstable angina pectoris, coronary artery bypass graft, cerebrovascular accident, or transient ischemic...
- Patients who have impaired cardiac function or clinically significant cardiac diseases, including any of the following:
- Congenital long QT syndrome;
- Significant ventricular or supraventricular arrhythmias (patients with sinus arrhythmia or chronic rate-controlled atrial fibrillation in the absence of other cardiac abnormalities are eligible);
- LVEF \< 50% by ECHO or MUGA;
- Other clinically significant heart disease such as known congestive heart failure New York Heart Association (NYHA) Class III-IV;
- Patients with QT interval ≥470 msec in females and ≥450 msec in males at screening using Fridericia's formula (determined as the mean of 3 QTcF values from the screening triplicate ECG obtained with adequate quality);
- Women who are pregnant or breastfeeding.
- WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy for at least 1 month before the first dose of the study drug, during the...
- Male patient who plans to father a child while enrolled in this study or within 4 months after the last dose of study drug;
- Not recovered from toxicity from prior anticancer therapy to baseline or Grade 1 (except toxicities which are not clinically significant such as alopecia, skin discoloration).
- History of an allogeneic bone marrow or solid organ transplant;
- Use of systemic anti-cancer agent (except luteinizing hormone-releasing hormone (LHRH) agonists, bisphosphonates and denosumab) or investigational drug ≤28 days or five half-lives whichever is shorter prior to the first...
- Radiation therapy ≤28 days prior to the first dose of study treatment, or likely to require radiation therapy at any time until the 30 days after the last dose of study treatment, except for palliative radiation therapy...
- Major surgery within 4 weeks before enrollment or surgery with ongoing post-operative complications);
- History of transfusion of platelets ≤2 weeks before the start of treatment;
- Patients who start erythropoietin or granulocyte-colony stimulating factor (G-CSF), pegfilgrastim, or filgrastim ≤3 weeks before screening;
- Patients taking medications known to have a significant risk of causing Torsades de Pointes. Patients who have discontinued any of these medications must have a wash-out period of at least 7 days or at least 5...
- History of use of H2 blockers (\<24 hours before the first dose of study treatment and during the study) and proton pump inhibitors (\<5 days before the first dose of study treatment and during the study).
- Patients with recent (within past 12 months) history, or are currently being treated for gastroesophageal ulcer. The following additional exclusion criteria will apply to patients enrolling in Phase 1b:
- Have been discontinued treatment due to a Grade 3 or higher immune-related (irAE) from prior anti-PD-1 or anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor...
- Patient is currently participating or has participated in a study of an investigational agent or using an investigational device within 30 days of administration of investigational products.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines are allowed.
- Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has a history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease or radiation pneumonitis.
The study team makes the final eligibility decision.
Where it's taking place
- Lafayette, Indiana, United States
- San Antonio, Texas, United States
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 Lafayette, Indiana, United States; San Antonio, Texas, United States. 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.