Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Sitravatinib
MGCD516 · 6 trials · 6 indications
An AE is any reaction, side effect or other undesirable medical event that occurs during participation in a clinical trial, regardless of treatment group or suspected causal relationship to study treatment. Assessment of AEs will include type, incidence, severity (graded by the National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE, Version 5.0\]), timing, seriousness, and relatedness to study treatment. A treatment-emergent AE (TEAE) is an AE that occurs after the first dose of any study treatment or any pre-existing condition that increases in severity after the first dose of study treatment.
Number of participants with treatment related adverse events which lead to study drug discontinuation.
An abnormal laboratory test result should be reported as an AE in the CRF only if it is associated with one or more of the following: * Clinical symptoms; * Requires additional tests (beyond repeats), treatment, or intervention; * Results in change in study treatment dosing; * Requires discontinuation from study treatment; and/or * Considered by the investigator or sponsor to be an AE.
Objective response is defined as the percent of participants documented by investigator assessment to have Complete Response (CR) or Partial Response (PR) in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). CR is defined as complete disappearance of all baseline target and non-target lesions with the exception of nodal disease; PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions.
Number and percentage of participants who experienced a response prior to surgery in accordance with RECIST 1.1. * CR is defined as complete disappearance of all baseline target and non-target lesions with the exception of nodal disease; * PR is defined as \>=30% decrease under baseline of the sum of diameters of all target measurable lesions; * Stable Disease (SD) is concluded when the single point in time response does not qualify for CR, PR or Progressive Disease (PD); * PD is defined as a 20% increase in the sum of diameters of target measurable lesions above the smallest sum observed with a minimum absolute increase of 5 mm, or unequivocal progression of pre-existing nontarget lesions.
(warfarin, dextromethorphan, midazolam, digoxin, and rosuvastatin) derived from the plasma concentration time profile before and after oral administration of sitravatinib
(warfarin, dextromethorphan, midazolam, digoxin, and rosuvastatin) derived from the plasma concentration time profile before and after oral administration of sitravatinib
(warfarin, dextromethorphan, midazolam, digoxin, and rosuvastatin) derived from the plasma concentration time profile before and after oral administration of sitravatinib
Characterization of AEs by incidence, severity, timing, seriousness \& relationship to study treatment
AUC from time zero to the last measured time point
Time to reach maximum observed plasma concentration
Area under the plasma concentration-time curve from time zero extrapolated to infinity moderate, or severe hepatic impairment compared to control subjects with normal hepatic function
Maximum observed plasma concentration
Terminal elimination half-life
Apparent total plasma clearance when dosed orally
Apparent volume of distribution when dosed orally
Unbound fraction
Characterization of AEs by incidence, severity, timing, seriousness \& relationship to study treatment
| Arm | Type | Description |
|---|---|---|
| Phase 2/3: Open label extension of parent study | EXPERIMENTAL | The current study is designed to allow continued access to sitravatinib and to evaluate the safety and tolerability of sitravatinib alone or in combination with other anticancer therapies in patients who are deriving clinical benefit in a previous parent clinical trial. |
| Sitravatinib and nivolumab | EXPERIMENTAL | Sitravatinib oral capsule administered daily 2 weeks alone then in combination with nivolumab administered as 240 mg IV every 2 weeks. Total treatment duration: 6-8 weeks prior to planned nephrectomy. |
| Phase 1, Part 1: Sitravatinib monotherapy (DDI cohort) | EXPERIMENTAL | To evaluate the potential for drug-drug interactions (DDI) with sitravatinib monotherapy. To determine the effect of sitravatinib on the pharmacokinetics (PK) of midazolam (CYP3A4 probe substrate), warfarin (CYP2C9 probe substrate), dextromethorphan (CYP2D6 probe substrate), rosuvastatin (BCRP probe substrate), and digoxin (P-gp probe substrate). |
| Phase 1, Part 1: Sitravatinib monotherapy (QTc cohort) | EXPERIMENTAL | To evaluate the QTc prolongation risk for sitravatinib in patients with advanced/metastatic solid tumors via C-QTc modeling. |
| Phase 1, Part 2: Combination Therapy (both DDI and QTc cohorts) | EXPERIMENTAL | To evaluate safety and tolerability of Sitravatinib treatment with the addition of the checkpoint inhibitor nivolumab. |
| Sitravatinib in healthy subjects | EXPERIMENTAL | Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in healthy subjects. |
| Sitravatinib in subjects with mild hepatic impairment | EXPERIMENTAL | Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in subjects with mild hepatic impairment |
| Sitravatinib in subjects with moderate hepatic impairment | EXPERIMENTAL | Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in subjects with moderate hepatic impairment |
| Sitravatinib in subjects with severe hepatic impairment | EXPERIMENTAL | Participants will receive a single dose of sitravatinib 100 mg receive on Day 1 in subjects with severe hepatic impairment |
| Phase 1: Dose Escalation | EXPERIMENTAL | Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment. |
| Phase 1b Dose Escalation Cohort A | EXPERIMENTAL | Patients with poor- or intermediate-risk RCC with clear cell component for first-line treatment |
| Phase 1b Dose Escalation Cohort B | EXPERIMENTAL | Patients with favorable-risk RCC with clear cell component for first-line treatment. |
| MGCD516 | EXPERIMENTAL | MGCD516 oral capsule, administered in escalating doses in Phase 1, beginning with daily dosing and exploring other regimens as necessary, in 21 or 28 days cycles |
| Name | Type | Description |
|---|---|---|
| Sitravatinib | DRUG | Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases. |
| Nivolumab | DRUG | Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody |
| Pembrolizumab | DRUG | Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody |
| Enfortumab Vedotin-Ejfv | DRUG | Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE) |
| Ipilimumab | DRUG | Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody |
| Warfarin | DRUG | CYP2C9 probe substrate |
| Dextromethorphan | DRUG | CYP2D6 probe substrate |
| Midazolam | DRUG | CYP3A4 probe substrate |
| Digoxin | DRUG | P-gp probe substrate |
| Rosuvastatin | DRUG | BCRP probe substrate |
| MGCD516 | DRUG | MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water. |
Inclusion Criteria: * Currently receiving sitravatinib single- agent or in combination with other therapeutic agent(s) in another Mirati- sponsored protocol * Currently tolerating the treatment regimen in the parent protocol * Experiencing clinical benefit with or without prior radiographic progres...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
MGCD516 is an investigational small molecule being studied for the treatment of advanced cancer. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in patients with advanced malignancies.
MGCD516 is being developed by Bristol-Myers Squibb Company, a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical research to evaluate the drug's potential in oncology.
MGCD516 is in Phase 1 clinical development. A Phase 1/1b study of the drug in patients with advanced cancer has been completed. The drug is investigational and has not received regulatory approval for any indication.
MGCD516 has been studied in a single clinical trial registered as NCT02219711, titled 'Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer.' This trial enrolled 193 participants in the United States and South Korea and has been completed.
MGCD516 is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in advanced cancer. Further studies would be needed to establish its safety and efficacy before any regulatory approval could be considered.