AzTrials
AzTrials

Malignant Solid TumorPhase 1NCT03009214

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

A Phase 1 study testing AMC303 in people with Malignant Solid Tumor, run by amcure GmbH at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Solid Tumor
What is being tested?
AMC303
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
7 sitesin 2 countries
Study dates
Dec 2016to 7 May 2021
Phase
Phase 1
Are there results?
None posted in the registry

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

  • 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 1.1. criteria
  • 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 AMC303.
  • Male or female patients, at least 18 years of age
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1
  • Life expectancy > 12 weeks.
Show all 20Show fewer
  • Adequate haematological function defined as
  • Absolute neutrophil count (ANC) > 1,500 / µL
  • Platelets > 100,000 / µL
  • Haemoglobin > 9 g /dL.
  • Adequate renal function defined as
  • Glomerular filtration rate (GFR) ≥ 50 ml/min according to local laboratory standard or
  • Serum creatinine < 1.5 mg / dL.
  • Adequate hepatic function defined as
  • Total bilirubin < 1.5x institutional upper limit of normal (ULN)
  • AST, ALT ≤ 3x institutional ULN or < 5x institutional ULN if known hepatic metastases
  • Alkaline phosphatase < 3x institutional ULN or < 5x institutional ULN if known hepatic metastases.
  • Patient may have central nervous system (CNS) involvement if metastases have been treated and are stable at least 4 weeks after completion of radiation therapy and/or surgery. Stable disease is defined as absence of new neurological symptoms, absence of the need for steroid therapy and radiographic confirmation of stable disease. Radiographic confirmation of stable disease 4 weeks after completion of radiation therapy is not required unless indicated by neurological examination.
  • All female subjects will be considered to be of childbearing potential unless they are postmenopausal (at least 12 months consecutive amenorrhea, in the appropriate age group and without other known or suspected cause), or have been sterilized surgically. For female participants and female partners of childbearing potential, willingness and able to use two forms of highly effective contraception methods (e.g. oral contraceptive and condom, intra-uterine device and condom) while on study and for 30 days after the last study treatment. For male participants or male partners of childbearing potential, willingness and able to use two forms of highly effective contraception methods (e.g. oral contraceptive and condom, intra-uterine device and condom,) while on study and for three months after the last study treatment.
  • Provision of signed Informed Consent prior to any study related procedure being performed

Who cannot join

  • Receipt of any other investigational agent within 28 days prior to first administration of AMC303. Investigational monoclonal antibodies must not be given within 6 weeks before treatment start with AMC303.
  • 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
Show all 13Show fewer
  • 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.
  • History of allergic reactions attributed to compounds of similar chemical or biological composition to AMC303.
  • Evidence of any other medical conditions that in the opinion of the investigator may interfere with the planned treatment, affect patient compliance or place the patient at high risk from treatment-related complications
  • Previous malignant disease other than the target malignancy to be investigated within the last 5 years with the exception of basal or squamous carcinoma of the skin or cervical carcinoma in situ
  • Legal incapacity or limited legal capacity

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

Spain5 sites

  • Vall d'Hebron Institute of Oncology (VHIO)

    Barcelona, 08035

  • Institut Català d'Oncologia, Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08908

  • START Madrid-CIOCC, Centro Integral Oncológico Clara Campal

    Madiedo, 28050

  • Hospital Universitario Virgen de la Victoria

    Málaga

  • Instituto de Investigación Sanitaria INCLIVA, Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

Belgium2 sites

  • Jules Bordet Instiut

    Brussels, 1000

  • Cliniques Universitaires Saint Luc

    Brussels, 1200

Other trials in Belgium

About this study

Official title: 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

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.

Being tested
AMC303
Keywords
solid epithelial cancer, CD44v6, c-Met, VEGFR-2, RON, receptor tyrosine kinase

What participants receive

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

  • AMC303Drug

    Also called CD44v6 inhibitor

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

Study groups in NCT03009214
Study groupRoleWhat they receive
AMC303Experimentalcohorts 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
Receives: Drug: AMC303

What is being measured

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

  1. Safety and tolerability of AMC303

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

    Measured: 6 months

Secondary outcomes (4)

  1. Pharmacokinetic properties of AMC303 (Cmax)

    Determine maximum plasma concentration (Cmax)

    Measured: 2 days

  2. Pharmacokinetic properties of AMC303 (AUC)

    Determine systemic exposure (AUC) after intravenous infusion

    Measured: 2 days

  3. Pharmacokinetic properties of AMC303 (t1/2)

    Determine half-life of AMC303 after intravenous infusion

    Measured: 2 days

  4. Response rate of treatment with AMC303 in patients with metastatic solid tumors

    Determination of the complete response (CR) and partial response (PR) in patients treated with AMC303

    Measured: 12 months

Timeline

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

  1. First posted4 Jan 2017 (estimated)
  2. Study startDec 2016
  3. Primary completion28 Jul 2020
  4. Study completion7 May 2021

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03009214
Sponsor's protocol ID
AMC303-01
Status last verified
May 2021
First submitted
19 Nov 2016
Last updated
10 May 2021
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Matzke-Ogi A, Jannasch K, Shatirishvili M, Fuchs B, Chiblak S, Morton J, Tawk B, Lindner T, Sansom O, Alves F, Warth A, Schwager C, Mier W, Kleeff J, Ponta H, Abdollahi A, Orian-Rousseau V. Inhibition of Tumor Growth and Metastasis in Pancreatic Cancer Models by Interference With CD44v6 Signaling. Gastroenterology. 2016 Feb;150(2):513-25.e10. doi: 10.1053/j.gastro.2015.10.020. Epub 2015 Oct 24.

    PubMed 26597578

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMC303 in people with Malignant Solid Tumor, run by amcure GmbH at 7 sites in 2 countries.

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 20 inclusion and 13 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: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Spain, Belgium. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability of AMC303 (time frame: 6 months). 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 NCT03009214, which also lists 1 linked publication.

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 10 May 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in