Clinical trial · Interventional
A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875
A First-in-human Dose-escalation and Expansion Study With the Antibody-drug Conjugate SYD1875 to Evaluate the Safety, Pharmacokinetics and Efficacy in Patients With 5T4-expressing Locally Advanced or Metastatic Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is the first-in-human study with SYD1875, an antibody-drug conjugate (ADC) comprising of a humanized IgG1 monoclonal antibody directed against the 5T4 oncofetal antigen covalently conjugated to a duocarmycin-based linker-drug. This study includes a dose-escalation part (Part 1) in which the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) will be determined, and an expansion part (Part 2) to evaluate efficacy and safety in specific patient cohorts.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SYD1875 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SYD1875
- description
- 5T4-targeting Antibody-Drug Conjugate
- interventionNames
- Drug: SYD1875
Primary outcomes (1)
- measure
- Incidence of dose-limiting toxicities
- timeFrame
- 21 days
- description
- Part 1
Secondary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 21 days
- description
- Part 2
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Main Inclusion Criteria: * Patient with histologically-confirmed, locally advanced or metastatic cancer who has progressed on standard therapy or for whom no standard therapy exists, with the following restriction: * Part 1: solid tumours of any origin * Part 2: three patient cohorts * Tumour 5T4 membrane staining according protocol * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1; * Adequate organ function * For Part 2: measurable disease Main Exclusion Criteria: * Having been treated with: 1. 5T4-targeting therapy at any time 2. Trastuzumab duocarmazine (SYD985) at any time 3. Other anticancer therapy within 4 weeks or as defined in the protocol 4. Hormone therapy within 1 week * History or presence of keratitis, clinically significant renal disease, lung disease, or cardiovascular disease as specified in the protocol * Symptomatic brain metastases, brain metastases requiring steroids or treatment for brain metastases within 8 weeks
References
Publications (0)
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