OncoMatch/Clinical Trials/NCT06014658
Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
Is NCT06014658 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies Antibody-Drug Conjugate for cancer.
Treatment: Antibody-Drug Conjugate — This is a first-in-human (FIH), open label Phase 1/1b / Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment. Phase 1 will identify potential optimal biologically relevant doses (OBRD) and the maximum tolerated dose (MTD) of MBRC-101 at one 1 or more dosing regimens. Phase 1b will evaluate the safety and preliminary clinical activity of MBRC-101 at potential OBRDs. Phase 1 and Phase 1b will both characterize single and multiple-dose PK profiles and evaluate incidence and persistence of anti-MBRC-101 Ab. Phase 2 will evaluate the efficacy of MBRC-101 at the RP2D from Phase1b.
Check if I qualifyExtracted eligibility criteria
Biomarker criteria
Allowed: EPHA5 expression
Availability of a tumor tissue sample (formalin-fixed paraffin embedded [FFPE]) must be confirmed for analysis of EphA5 expression based on IHC. Tumor EphA5 expression will not be required for enrollment.
Disease stage
Metastatic disease required
advanced metastatic solid tumors refractory to standard treatment
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: MMAE-conjugated antibody-drug conjugate (brentuximab vedotin, polatuzumab vedotin, enfortumab vedotin, disitamab vedotin, tisotumab vedotin)
Exception: Prior agents conjugated to MMAE are allowed for Phase 1 but not for Phase 1b or Phase 2
Prior agents conjugated to MMAE are allowed for Phase 1 but not for Phase 1b or Phase 2. These exclusionary agents include brentuximab vedotin, polatuzumab vedotin, enfortumab vedotin, disitamab vedotin, tisotumab vedotin, and any MMAE-conjugated agents approved subsequent to the publication of this Protocol.
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL; No RBC or platelet transfusions within 14 days of first dose
Kidney function
Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by the CKD-EPI or similar equation or as measured by 24-hour urine collection
Liver function
Total bilirubin ≤ 1.5 × upper limit normal (ULN); AST ≤ 3.0 × ULN; ALT ≤ 3.0 × ULN
Cardiac function
INR < 1.5 (or ≤ 3.0 if on therapeutic anticoagulation); Baseline QTcF ≤ 470 msec
Hematologic function, as follows (no red blood cell [RBC] or platelet transfusions are allowed within 14 days of the first dose of MBRC-101): Absolute neutrophil count (ANC) ≥ 1.0 × 10^9/L; Platelet count ≥ 100 × 10^9/L; Hemoglobin ≥ 9 g/dL. Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min by the CKD-EPI or similar equation or as measured by 24-hour urine collection. Total bilirubin ≤ 1.5 × upper limit normal (ULN). AST ≤ 3.0 × ULN. ALT ≤ 3.0 × ULN. International normalised ratio (INR) < 1.5 (or ≤ 3.0 if on therapeutic anticoagulation). A baseline QT (time from the beginning of the Q wave to the end of the T wave) interval as corrected by Fridericia's formula (QTcF) > 470 msec [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCSF Helen Diller Family Comprehensive Cancer Center · San Francisco, California
- University of Colorado, Anschutz Cancer Pavilion (ACP( · Aurora, Colorado
- Winship Cancer Institute, Emory University · Atlanta, Georgia
- University of Chicago Medical Center · Chicago, Illinois
- Horizon Oncology Research · Lafayette, Indiana
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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