Safety, PK, and Preliminary Efficacy of MBRC-101 in Advanced Refractory Solid Tumors
ConditionCancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMBrace Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide written consent on an Informed Consent Form (ICF), approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to any study-specific evaluation. Patients should have the ability to read and understand the ICF, ask for any clarifications from the study staff, and be able to comply with all planned study procedures.
18 years of age or older at the time of informed consent.
Female patients must be at least 2 years postmenopausal (defined as 2 years without menses), surgically sterile (at least 6 months prior to dosing; must be documented) or practicing effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) and willing to continue to use effective contraception for the duration of study participation and for 6 months after the final dose of study drug. Female patients must be nonlactating and have a negative serum pregnancy test result at screening and baseline.
Male patients must agree to use effective contraception (must agree to use 2 forms of contraception, 1 of which must be a barrier method) for the duration of study participation and for 6 months after the final dose of study drug.
Disqualifiers
Preexisting sensory neuropathy Grade ≥ 2.
Preexisting motor neuropathy Grade ≥ 2.
Uncontrolled central nervous system metastases.
Use of any investigational drug within 14 days prior to the first dose of study drug.
Trial design
Design model
Sequential
Treatments tested in this trial
Antibody-Drug Conjugate
DrugMBRC-101: AN ANTI-EPHA5 MONOMETHYL AURISTATIN E (MMAE) ANTIBODY DRUG CONJUGATE
Treatment groups
130 Participants
are divided into 3 treatment groupsGroup A: Phase 1 Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b ExpansionExperimental treatment 1 intervention
Group C: Phase 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Occurrence of treatment-emergent adverse events (TEAEs)
TEAEs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v.5.0.
Time frame
Up to 24 Months2
Occurrence of dose limiting toxicities (DLTs) during the DLT evaluation period
The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time frame
21 DaysSecondary outcomes
1
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1.
Time frame
Up to 24 Months2
Duration of Response (DOR)
DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease per RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.
Time frame
Up to 24 Months3
Progression-Free Survival (PFS)
PFS will be calculated from the date of first dose of MBRC-101 to the date of first documented evidence of progressive disease as defined by RECIST version 1.1 response criteria or death due to any cause, whichever occurs first.
Time frame
Up to 24 Months4
Disease Control Rate (DCR)
DCR will be defined as the proportion of patients with best overall response of Complete Response, Partial Response, or Stable Disease (SD) according to the response evaluation criteria in solid tumors (RECIST) version 1.1.
Time frame
Up to 24 MonthsSponsors and contacts
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Source ClinicalTrials.gov