Study of MC001 in Patients With Advanced Solid Tumours
NCT07929961, Phase 1, Not yet recruiting, National University Hospital, Singapore
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Study of MC001 in Patients With Advanced Solid Tumours | ClinicalTrials.gov |
| NCT number | NCT07929961 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 80 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | National University Hospital, Singapore | ClinicalTrials.gov |
| Conditions | Pancreatic Ductal Adenocarcinoma (PDAC), Nasopharyngeal Carcinoma, Advanced Solid Tumours | ClinicalTrials.gov |
| Interventions | MC001 | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Adverse Events (AEs) | From informed consent until 30 days after the last dose of MC001 (approximately 2 years) | Incidence and severity of adverse events (AEs) occurring during the study period, assessed and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0. CTCAE grades range from Grade 1 (mild) to Grade 5 (death related to an adverse event). | ClinicalTrials.gov |
| Primary | Incidence of Serious Adverse Events (SAEs) | From screening until end of treatment (up to approximately 2 years) | Number of participants experiencing one or more serious adverse events (SAEs) during the study period. | ClinicalTrials.gov |
| Primary | Incidence of dose-limiting toxicities | During Cycle 1 (21 days) | Number of participants experiencing a dose-limiting toxicity (DLT) during Cycle 1. DLTs are protocol-defined adverse events occurring during the first 21 days of treatment that are considered at least possibly related to the study drug and are graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0. | ClinicalTrials.gov |
| Primary | Maximum Tolerated Dose (MTD) | From first dose until completion of dose escalation (up to approximately 24 months) | The maximum tolerated dose (MTD) is determined using the modified Toxicity Probability Interval (mTPI-2) design and is defined as the highest dose level at which the observed rate of dose-limiting toxicities (DLTs) during Cycle 1 does not exceed the prespecified target toxicity probability. | ClinicalTrials.gov |
| Primary | Maximum Administered Dose (MAD) | From first dose until completion of dose escalation (up to approximately 24 months) | The maximum administered dose (MAD) is determined as the highest dose level of MC001 evaluated during the dose-escalation phase, regardless of whether a maximum tolerated dose (MTD) is reached. | ClinicalTrials.gov |
| Primary | Recommended Dose for Expansion (RDE) | From first dose until determination of the recommended dose for expansion (approximately 6 to 12 months) | The recommended dose for expansion (RDE) is selected for evaluation in the expansion cohorts based on an integrated assessment of dose-limiting toxicities (DLTs), overall safety and tolerability, pharmacokinetic data, and preliminary evidence of antitumour activity. The RDE may be equal to or lower than the maximum tolerated dose (MTD). | ClinicalTrials.gov |
| Secondary | Progression-Free Survival (PFS) | From first dose until documented disease progression or death from any cause, up to approximately 2 years | Progression-free survival (PFS), defined as the time from first dose of MC001 to documented disease progression according to RECIST version 1.1 or death from any cause, whichever occurs first. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From first dose until death from any cause, up to approximately 2 years | Overall survival (OS), defined as the time from first dose of MC001 to death from any cause. | ClinicalTrials.gov |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of MC001 | From pre-dose until end of treatment (up to approximately 2 years) | Maximum observed plasma concentration (Cmax) of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE) following administration of MC001. | ClinicalTrials.gov |
| Secondary | Changes in ADCC Activity | From baseline until end of treatment (up to approximately 2 years) | Changes from baseline in antibody-dependent cellular cytotoxicity (ADCC) activity assessed using protocol-defined immune correlative analyses of peripheral blood samples collected during treatment. | ClinicalTrials.gov |
| Secondary | Objective Response Rate (ORR) | From first dose until disease progression, withdrawal, or end of treatment (up to approximately 2 years) | Objective response rate (ORR), defined as the proportion of participants achieving a best overall response of complete response (CR) or partial response (PR) according to RECIST version 1.1. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Serum CA19-9 | From baseline until end of treatment (up to approximately 2 years) | Change from baseline in serum carbohydrate antigen 19-9 (CA19-9) levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Plasma Epstein-Barr Virus DNA | From baseline until end of treatment (up to approximately 2 years) | Change from baseline in plasma Epstein-Barr virus (EBV) DNA levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Serum CA-125 | From baseline until end of treatment (up to approximately 2 years) | Change from baseline in serum cancer antigen 125 (CA-125) levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001. | ClinicalTrials.gov |
| Secondary | Change From Baseline in Carcinoembryonic Antigen | From baseline until end of treatment (up to approximately 2 years) | Change from baseline in serum carcinoembryonic antigen (CEA) levels as a predefined blood-based biomarker to characterise the pharmacodynamic effects of MC001. | ClinicalTrials.gov |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of MC001 | From pre-dose until end of treatment (up to approximately 2 years) | Time to reach maximum observed plasma concentration (Tmax) of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE) following administration of MC001. | ClinicalTrials.gov |
| Secondary | Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Concentration (AUC0-last) of MC001 | From pre-dose until end of treatment (up to approximately 2 years) | Area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-last) for conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE). | ClinicalTrials.gov |
| Secondary | Area Under the Plasma Concentration-Time Curve Over the Dosing Interval (AUCτ) of MC001 | From pre-dose until end of treatment (up to approximately 2 years) | Area under the plasma concentration-time curve over the dosing interval (AUCτ) for conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE). | ClinicalTrials.gov |
| Secondary | Terminal Elimination Half-life (t½) of MC001 | From pre-dose until end of treatment (up to approximately 2 years) | Terminal elimination half-life (t½), where estimable, of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE). | ClinicalTrials.gov |
| Secondary | Trough Plasma Concentration (Ctrough) of MC001 | From pre-dose until end of treatment (up to approximately 2 years) | Trough plasma concentration (Ctrough) of conjugated ADC, total antibody, and unconjugated monomethyl auristatin E (MMAE). | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)