Clinical trialPhase 1Not yet recruiting
Study of MC001 in Patients With Advanced Solid Tumours
Phase I First-in-Human Study of MC001 (ADoBind Dimeric IgG-Monomethyl Auristatin E), a First-in-Class Dimeric Antibody-Drug Conjugate Targeting Folate Receptor Alpha (FRα), in Patients With Advanced Solid Tumours
- Outcome
- Ongoing
- Phase
- Phase 1
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 16 November 2026
- Expected end
- 30 November 2031
- Enrollment
- 80 participants
- Sites
- 1
- Primary outcomes
- Incidence of Adverse Events (AEs); Incidence of Serious Adverse Events (SAEs); Incidence of dose-limiting toxicities; Maximum Tolerated Dose (MTD); Maximum Administered Dose (MAD)
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 10 November 2026
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
The goal of this clinical trial is to evaluate the safety and tolerability of MC001 and to determine the appropriate dose for further development in adults with advanced solid tumours, with expansion cohorts in pancreatic ductal adenocarcinoma (PDAC) and nasopharyngeal carcinoma (NPC). The main questions it aims to answer are: * What is the maximum tolerated dose (MTD), maximum administered dose (MAD), and recommended dose for expansion (RDE) of MC001? * How does MC001 behave in the body following single and multiple doses? * Does MC001 show preliminary antitumour activity in patients with PDAC and NPC? * What are the pharmacodynamic effects of MC001? * What medical problems do participants have when taking MC001? Research participants will: * Receive MC001 every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, or at the investigator's discretion. * Visit the clinic every 21 days for drug administration, biopsy, and assessments including blood tests, eye tests, and imaging.
Detailed description public domain (ClinicalTrials.gov)
This is a first-in-human, open-label, Phase I clinical trial evaluating MC001 administered as monotherapy via intravenous infusion every 21 days (Q3W) in patients with advanced folate receptor-expressing solid tumours. Each treatment cycle is defined as 21 days. The study comprises two sequential components: a Dose Escalation Phase followed by a Dose Expansion Phase. During dose escalation, the mTPI-2 method will be used to determine the appropriate dose across 7 dose levels. Following completion of dose escalation, expansion cohorts will enrol patients with PDAC and NPC at the recommended dose for expansion (RDE) to further evaluate safety and preliminary antitumour activity.