Clinical trial · Interventional
Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer
A Phase 1/1b Study of MGCD516 in Patients With Advanced Solid Tumor Malignancies
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles. During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MGCD516 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MGCD516
- description
- 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
- interventionNames
- Drug: MGCD516
Primary outcomes (3)
- measure
- Type of dose limiting adverse event
- timeFrame
- Up to 3 weeks on treatment
- measure
- Area under the plasma concentration versus time curve (AUC) of MGCD516
- timeFrame
- Up to 72 hours
- measure
- Peak Plasma Concentration (Cmax) of MGCD516
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic or unresectable solid tumor malignancy * Standard treatment is not available * Adequate bone marrow and organ function Exclusion Criteria: * History of a significant cardiovascular illness * Prolonged corrected QT (QTc) interval * Left ventricular ejection fraction \< 40% * Symptomatic or uncontrolled brain metastases * Other active cancer
References
Publications (3)
- DERIVEDBazhenova L, Kim DW, Cho BC, Goel S, Heist R, Werner TL, Eaton KD, Wang JS, Pant S, Adkins DR, Blakely CM, Yan X, Neuteboom S, Christensen JG, Chao R, Bauer T. Sitravatinib in patients with solid tumors selected by molecular alterations: results from a Phase Ib study. Future Oncol. 2024 Dec;20(39):3213-3227. doi: 10.1080/14796694.2024.2418285. Epub 2024 Nov 8. PMID 39513224
- DERIVEDPant S, Cho BC, Kyriakopoulos CE, Spira A, Tannir N, Werner TL, Yan X, Neuteboom S, Chao R, Goel S. Targeting multiple receptor tyrosine kinases with sitravatinib: A Phase 1b study in advanced renal cell carcinoma and castrate-resistant prostate cancer. Invest New Drugs. 2024 Oct;42(5):547-558. doi: 10.1007/s10637-024-01465-9. Epub 2024 Aug 21. PMID 39168901
- DERIVEDBauer T, Cho BC, Heist R, Bazhenova L, Werner T, Goel S, Kim DW, Adkins D, Carvajal RD, Alva A, Eaton K, Wang J, Liu Y, Yan X, Christensen J, Neuteboom S, Chao R, Pant S. First-in-human phase 1/1b study to evaluate sitravatinib in patients with advanced solid tumors. Invest New Drugs. 2022 Oct;40(5):990-1000. doi: 10.1007/s10637-022-01274-y. Epub 2022 Jun 29. PMID 35767205