A Safety, Tolerability and Pharmacokinetic Dose Escalation and Expansion, Phase I/Ib Study of AMC303 as Monotherapy in Patients With Advanced or Metastatic, Malignant Solid Tumour of Epithelial Origin

amcure GmbH7 sites in 2 countries55 target enrollmentDecember 2016

ConditionsMalignant Solid Tumor

InterventionsAMC303

DrugsAMC303

Overview

Phase: Phase 1
Intervention: AMC303
Conditions: Malignant Solid Tumor
Sponsor: amcure GmbH
Enrollment: 55
Locations: 7
Primary Endpoint: Safety and tolerability of AMC303
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

December 2016

End Date

May 7, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

amcure GmbH

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically confirmed and documented, advanced or metastatic, accessible malignant solid tumour of epithelial origin and for which no standard therapy exists or standard therapy has failed.
•Presence of a measurable tumour according to RECIST 1.
•At least 4 weeks from the completion of any previous cytotoxic chemotherapy, 6 weeks from biological therapy (monoclonal antibodies) or cancer immunotherapy (immune checkpoint modulators) or 2 weeks from targeted therapy (receptor tyrosine kinase inhibitors) at time of administration of AMC
•Male or female patients, at least 18 years of age
•Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
•Life expectancy \> 12 weeks.
•Adequate haematological function defined as
•Absolute neutrophil count (ANC) \> 1,500 / µL
•Platelets \> 100,000 / µL
•Haemoglobin \> 9 g /dL.

Exclusion Criteria

•Receipt of any other investigational agent within 28 days prior to first administration of AMC
•Investigational monoclonal antibodies must not be given within 6 weeks before treatment start with AMC
•Enrolment in another clinical study with an investigational drug
•Presence of residual toxicities of CTCAE Grade \> 1 after prior anti-tumour therapy within 2 weeks of first treatment with AMC303 with the exception of Grade 3 alopecia and infusion site reactions
•Severe concurrent illness or psychiatric illness/social situation that would limit compliance with study requirements
•Anticipation of major surgical procedures within first 4 weeks of first dose
•Pregnancy or breast-feeding as determined by a serum pregnancy test (β-HCG) at screening prior to administration of AMC303 and willingness to father a child or to become pregnant
•Untreated acute infectious disease
•Patient is known to be suffering from Acquired Immune Deficiency Syndrome (AIDS) or is known to be HIV seropositive without AIDS defining disease
•Known chronic hepatitis B or C.

Arms & Interventions

AMC303

cohorts will receive ascending doses of AMC303 as intravenous infusion Planned doses are: 0.1 mg/kg, 0.5 mg/kg, 1.5 mg/kg, 4 mg/kg, 10 mg/kg and 20 mg/kg

Intervention: AMC303

Outcomes

Primary Outcomes

Safety and tolerability of AMC303

Time Frame: 6 months

Number of patients with treatment-related adverse events as assessed by CTCAE v4.0

Secondary Outcomes

Pharmacokinetic properties of AMC303 (t1/2)(2 days)
Pharmacokinetic properties of AMC303 (Cmax)(2 days)
Pharmacokinetic properties of AMC303 (AUC)(2 days)
Response rate of treatment with AMC303 in patients with metastatic solid tumors(12 months)