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Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

ConditionsBiliary Tract CancerBreast CancerCervical CancerColon CancerEndometrial CancerEsophageal CancerGastric CancerGastroEsophageal CancerHead and Neck CancerHepatocellular CancerNon-small Cell Lung CancerPancreatic CancerProstate CancerRectal CancerRenal CancerThyroid Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorModeX Therapeutics, An OPKO Health Company

About this trial

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be ≥ 18 years of age

Histologically or cytologically confirmed diagnosis of metastatic solid tumors

Eastern Cooperative Oncology Group (ECOG) performance status 0-1

All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.

Disqualifiers

Any clinically significant cardiac disease

Unresolved toxicities from previous anticancer therapy

Prior solid organ or hematologic transplant

Known untreated, active, or uncontrolled brain metastases

Trial design

Design model

Sequential

Treatments tested in this trial

  • MDX2001

    Drug

    MDX2001 intravenous infusion

Treatment groups

285 Participants
are divided into 4 treatment groups
Group A: Phase 1a - MDX2001 Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1b - Indication OptimizationExperimental treatment 1 intervention
Group C: Phase 1b - Dose OptimizationExperimental treatment 1 intervention
Group D: Phase 2a - Cohort ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

All Phases: Adverse events (AEs)

Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters

Time frame
Baseline until end of study, up to approximately 9 months
2

Phase 1b and Phase 2a: Objective response rate of MDX2001

Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Time frame
From date of enrollment until the end of treatment, up to approximately 6 months
3

Phase 1: Recommended Phase 2 dose (RP2D)

Recommended Phase 2 dose is determined following the evaluation of MDX2001 safety including the incidences of dose limiting toxicities (DLTs), MDX2001 anti-tumor activity, and MDX2001 pharmacokinetics

Time frame
Baseline until end of study, up to approximately 9 months

Secondary outcomes

1

Phase 1a: Objective response rate of MDX2001

Objective response rate is defined as the proportion of patients who achieve a complete response (CR) or partial response (PR) per RECIST v1.1.

Time frame
From date of enrollment until the end of treatment, up to approximately 6 months
2

All Phases: Duration of response (DOR)

Duration of response is defined as the time from first documentation of response (complete response \[CR\] or partial response \[PR\]) to documentation of objective disease progression or death due to any cause, whichever occurs first

Time frame
From date of enrollment until the end of treatment, up to approximately 6 months
3

All Phases: Time to response (TTR)

Time to response is defined as the time from first dose to first documentation of response (CR or PR)

Time frame
From date of enrollment until the first documentation of response (CR or PR), approximately 4 months
4

All Phases: Disease control rate (DCR)

Disease control rate is defined as the proportion of evaluable patients with a best overall response (BOR) of stable disease, CR or PR

Time frame
From date of enrollment until the end of treatment, up to approximately 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

ModeX Therapeutics, An OPKO Health Company

Lead sponsor

Source ClinicalTrials.gov
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