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Pancreatic Ductal Adenocarcinoma (PDAC)Phase 1NCT07909356

A Study of MC001 in Patients With Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Other Folate Receptor Alpha (FRα)-Expressing Solid Tumors

A Phase 1 study testing MC001 in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Advanced Solid Tumor Cancer, run by Medicovestor, Inc at 4 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this First-in-Human, Phase 1 study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of MC001 in adults with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and other solid tumors that have relapsed or… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MC001
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
4 sitesUnited States
Study dates
Dec 2026to Jan 2029
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18 years or older.
  • Histologically and radiologically confirmed advanced surgically unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC) or other solid tumors.
  • Folate Receptor alpha (FRα) expression determined by immunohistochemistry (IHC) at a central laboratory:
  • Part A (Phase 1a Dose Escalation): FRα expression status will be assessed primarily for pharmacodynamic evaluation (not required for enrollment).
  • Part B (Phase 1b Dose Expansion): FRα expression must be documented on the cell surface in at least 30% of PDAC tumor cells prior to enrollment.
  • Failed at least one prior line of systemic chemotherapy. If daraxonrasib is accessible to the patient, the patient must have failed at least one line of systemic chemotherapy and prior treatment with daraxonrasib.
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  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Adequate organ and bone marrow function:
  • Hematologic: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, platelets >= 100 x 10^9/L, hemoglobin >= 9 g/dL.
  • Hepatic: Total bilirubin <= 1.5 x upper limit of normal (ULN); ALT and AST <= 2.5 x ULN (or <= 5 x ULN in case of liver involvement).
  • Renal: Creatinine clearance >= 60 mL/min calculated by Cockcroft-Gault formula.
  • Coagulation: Prothrombin time (PT)/International Normalized Ratio (INR) <= 1.5 x ULN.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Estimated life expectancy >= 3 months per investigator's assessment.
  • Female patients must not be pregnant or breastfeeding, and must be either not of childbearing potential or agree to use highly effective contraception from 1 month before study start through 6 months after completion of study treatment. Male patients with partners of childbearing potential must agree to use highly effective contraception during the study and for up to 6 months after the last dose.
  • Left ventricular ejection fraction (LVEF) >= 50% by echocardiogram, and Fridericia-corrected QT interval (QTcF) < 470 ms for both sexes.
  • Availability of archival or fresh tumor tissue for biomarker analysis.

Who cannot join

  • Prior exposure to antibody-drug conjugates (ADCs) targeting FRα or conjugated to monomethyl auristatin E (MMAE).
  • History of allergy to immunoglobulins or MMAE.
  • Receipt of radiation therapy <= 14 days before Cycle 1 Day 1, or failure to recover to Grade <= 1 from treatment-related side effects.
  • Symptomatic central nervous system (CNS) malignancy. (Patients with asymptomatic or treated CNS metastases may be eligible if not receiving corticosteroids or anticonvulsants and disease is stable for >= 60 days).
  • Peripheral sensory neuropathy Grade >= 2.
  • Active infection, including Human Immunodeficiency Virus (HIV), requiring systemic therapy within <= 7 days prior to Cycle 1 Day 1.
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  • Active, uncontrolled Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection:
  • HBsAg-positive patients are eligible if they have received HBV antiviral therapy for >= 4 weeks prior to first dose, have an undetectable HBV viral load at screening, and remain on antiviral therapy throughout the study.
  • HBsAg-negative, anti-HBc total positive patients are eligible if HBV viral load is undetectable.
  • Patients with a history of HCV infection are eligible if HCV viral load is undetectable at screening and curative antiviral therapy was completed >= 12 weeks prior to study treatment.
  • History of major ventricular arrhythmias (e.g., ventricular tachycardia, ventricular fibrillation, Torsades de Pointes [TdP]).
  • Major surgical intervention <= 28 days prior to Informed Consent Form (ICF) signature or incomplete wound healing after surgery.
  • Vaccination with a live or live-attenuated vaccine within 30 days prior to the first dose of trial intervention.
  • Pregnancy or lactation.
  • Unable or unwilling to sign the ICF, or patient is incarcerated.
  • Refractory hypokalemia, congenital long QT syndrome, or family history of long QT syndrome; implantable pacemakers or automatic implantable cardioverter defibrillators; unstable angina requiring treatment; clinically significant bradycardia (<50 beats/min), tachycardia (>100 beats/min), or clinically significant ECG abnormalities; or use of drugs with a known risk of causing Torsades de Pointes (TdP) or QT interval prolongation within 4 weeks prior to the first dose.

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Melissa Askin, MS, BSN, CCRP contact

410-231-1512

melissa.askin@acroclinical.com

United States4 sites

  • NEXT Oncology

    Fairfax, Virginia, 22031

  • Carolina BioOncology Institute, PLLC

    Huntersville, North Carolina, 28078

  • NEXT Oncology

    San Antonio, Texas, 78229

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

About this study

Official title: A First-in-Human, Open-Label, Multicenter, Phase 1, Dose Escalation Study With Cohort Expansion to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of MC001, a Dimeric Antibody-Drug Conjugate (ADC), in Patients With Advanced or Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) and Other Solid Tumors Expressing Folate Receptor Alpha (FRα)

The purpose of this First-in-Human, Phase 1 study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), immunogenicity, and preliminary antitumor activity of MC001 in adults with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and other solid tumors that have relapsed or are refractory to standard therapies. MC001 is an investigational dimeric antibody-drug conjugate (ADC) that targets folate receptor alpha (FRα) and delivers a microtubule-disrupting cytotoxic payload, monomethyl auristatin E (MMAE).

The study will be conducted in two sequential parts:

Read more

Part A (Dose Escalation): Evaluates ascending intravenous (IV) dose levels of MC001 administered once every 3 weeks (Q3W) using a standard 3+3 design in patients with advanced solid tumors to identify dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD), and the recommended dose for expansion (RDE).

Part B (Dose Expansion): Evaluates MC001 at the selected RDE in patients with advanced or metastatic PDAC whose tumors express FRα on at least 30% of tumor cells to further characterize safety and preliminary efficacy.

Being tested
MC001
Keywords
MC001, Folate Receptor Alpha, FRα, Antibody-drug conjugate, ADC, ADoBind, MMAE, PDAC, First-in-Human
Medical subject headings
Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MC001Biological

    Dimeric fully human IgG1 monoclonal antibody targeting Folate Receptor alpha (FRα) conjugated to Monomethyl Auristatin E (MMAE) via a protease-cleavable linker. Administered as an IV infusion once every 21 days (Q3W) following premedication with dexamethasone, diphenhydramine, acetaminophen, and a 5-HT3 antagonist.

Study groups in NCT07909356
Study groupRoleWhat they receive
Part A: MC001 Dose Escalation (Phase 1a)ExperimentalPatients with advanced or metastatic PDAC or other solid tumors will receive escalating doses of MC001 administered via intravenous (IV) infusion once every 21 days (Q3W) following a 3+3 design across 5 planned dose levels: Dose Level 1 (0.3 mg/kg), Dose Level 2 (0.6 mg/kg), Dose Level 3 (1.0 mg/kg), Dose Level 4 (1.6 mg/kg), and Dose Level 5 (2.2 mg/kg). Treatment continues until disease progression, unacceptable toxicity, or withdrawal.
Receives: Biological: MC001
Part B: MC001 Dose Expansion in PDAC (Phase 1b)ExperimentalApproximately 12 patients with advanced or metastatic PDAC with documented FRα expression in ≥30% of tumor cells will receive MC001 at the Recommended Dose for Expansion (RDE) determined in Part A, administered via IV infusion once every 21 days (Q3W) until disease progression, unacceptable toxicity, or withdrawal.
Receives: Biological: MC001

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Incidence and severity of AEs and SAEs, including clinically significant changes in laboratory parameters, vital signs, and ECGs, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0.

    Measured: From first dose of study drug through 30 days after the last dose (up to approximately 36 months)

  2. Number of Participants Experiencing Dose-Limiting Toxicities (DLTs) in Part A (Dose Escalation)

    A DLT is defined as any protocol-specified treatment-related hematologic, non-hematologic, or cardiac (QTcF) toxicity graded per NCI CTCAE v6.0 occurring during the DLT evaluation period. The incidence of DLTs in Cycle 1 is used to determine the Maximum Tolerated Dose (MTD, defined as the highest dose level at which ≤1 of 6 participants experiences a DLT) and Recommended Dose for Expansion (RDE).

    Measured: Cycle 1 (Day 1 to Day 21)

Secondary outcomes (10)

  1. Maximum Observed Plasma Concentration (Cmax) of MC001 (ADC), Total Antibody, and Unconjugated MMAE

    Plasma Cmax derived from intensive blood sampling in Cycle 1 and sparse sampling in subsequent cycles.

    Measured: Cycle 1 (Days 1, 2, 8, and 15) and Day 1 of subsequent 21-day cycles (up to approximately 36 months)

  2. Area Under the Plasma Concentration-Time Curve (AUC) of MC001 (ADC), Total Antibody, and Unconjugated MMAE

    Plasma AUC derived from pharmacokinetic blood sampling.

    Measured: Cycle 1 (Days 1, 2, 8, and 15) and Day 1 of subsequent 21-day cycles (up to approximately 36 months)

  3. Terminal Elimination Half-Life (T1/2) of MC001 (ADC), Total Antibody, and Unconjugated MMAE

    Terminal half-life calculated from plasma concentration-time profiles during Cycle 1.

    Measured: Cycle 1 (Day 1 through Day 15)

  4. Objective Response Rate (ORR)

    Proportion of participants in the response-evaluable analysis set achieving a confirmed Complete Response (CR) or Partial Response (PR) as determined by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

    Measured: From first dose of study drug until disease progression or treatment discontinuation (assessed prior to Cycles 3 and 5, and every 3 cycles thereafter, up to approximately 36 months)

  5. Duration of Response (DoR)

    Time from the date of first documented confirmed objective response (CR or PR) to the date of first documented disease progression per RECIST v1.1 or death from any cause, whichever occurs first.

    Measured: From date of first documented CR or PR until disease progression or death (up to approximately 36 months)

  6. Disease Control Rate (DCR)

    Proportion of participants achieving CR, PR, or Stable Disease (SD, maintained for ≥6 weeks from start of treatment) as their best overall response per RECIST v1.1.

    Measured: From first dose of study drug until disease progression or treatment discontinuation (up to approximately 36 months)

  7. Progression-Free Survival (PFS)

    Time from the date of the first dose of MC001 to the date of first documented progressive disease per RECIST v1.1 or death due to any cause, whichever occurs first.

    Measured: From first dose of study drug until disease progression or death (up to approximately 36 months)

  8. Overall Survival (OS)

    Time from the date of the first dose of MC001 to the date of death due to any cause.

    Measured: From first dose of study drug until death from any cause (up to approximately 36 months)

  9. Percentage of Participants With Anti-Drug Antibodies (ADAs) to MC001

    Incidence and persistence of treatment-emergent anti-drug antibodies (ADAs) evaluated via a tiered analytical approach (screening, confirmatory, and titer assays).

    Measured: Screening, Cycle 1 (Days 1, 8, 15), Cycle 2 Day 1, Cycle 3 Day 1, every 2nd cycle thereafter, End of Treatment, and 30 and 90 days post-last dose (up to approximately 36 months)

  10. Concentration-QTc Relationship: Change From Baseline in Fridericia-Corrected QT Interval (ΔQTcF)

    Relationship between plasma MC001 concentrations and change from baseline in QTcF (ΔQTcF) evaluated via continuous Holter ECG monitoring paired with time-matched PK sampling.

    Measured: Cycle 1 (Day 1 pre-dose through 24 hours post-infusion, Day 8, and Day 14), Cycle 3 Day 1, and Cycle 6 Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Nov 2026
  2. Study startDec 2026 (estimated)
  3. Primary completionJan 2029 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
Two-part study consisting of a 3+3 sequential dose-escalation phase (Part A) across 5 planned dose levels (0.3, 0.6, 1.0, 1.6, and 2.2 mg/kg Q3W) in advanced solid tumors, followed by a single-arm cohort expansion phase (Part B) at the Recommended Dose for Expansion (RDE) in FRα-expressing PDAC.
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07909356
Sponsor's protocol ID
MC001-101
Status last verified
Oct 2026
First submitted
26 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be shared publicly due to patient privacy and confidentiality considerations in a small Phase 1 first-in-human study.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing MC001 in people with Pancreatic Ductal Adenocarcinoma (PDAC) and Advanced Solid Tumor Cancer, run by Medicovestor, Inc at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melissa Askin, MS, BSN, CCRP (410-231-1512, melissa.askin@acroclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: From first dose of study drug through 30 days after the last dose (up to approximately 36 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07909356.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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