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A Safety and Pharmacokinetic Phase I/Ib Study of AMC303 in Patients With Solid Tumours

NCT03009214 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2021-05-10

No results posted yet for this study

Summary

This is a two part Phase I/Ib, open-label, non-randomized and multi-center, dose escalation study with a 3+3 design (Part 1) and an expansion cohort at the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) (Part 2). If MTD is not reached in Part 1, RP2D will be determined after completion of Part 1 considering safety and tolerability, also beyond the dose limiting toxicity (DLT) period, pharmacokinetic (PK) and pharmacodynamic (PD) results.

Conditions

  • Malignant Solid Tumor

Interventions

DRUG

AMC303

AMC303 is a CD44v6 inhibitor blocking receptor tyrosine kinase (RTK) pathways

Sponsors & Collaborators

  • amcure GmbH

    lead INDUSTRY

Principal Investigators

  • Klaus Dembowsky, MD PhD · amcure GmbH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2020-07-28
Completion
2021-05-07

Countries

  • Belgium
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03009214 on ClinicalTrials.gov