Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04341181

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Led by Ulrik Lassen · Updated on 2025-07-25

300

Participants Needed

7

Research Sites

52 weeks

Total Duration

On this page

Sponsors

U

Ulrik Lassen

Lead Sponsor

R

Roche Pharma AG

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are conducting the ProTarget study, a phase II clinical trial, to evaluate the safety and effectiveness of commercially approved cancer drugs used off-label to target specific DNA changes in advanced cancer. The study focuses on patients whose tumors have particular genomic variants identified through accredited tests. It aims to assess anti-tumor activity or disease stability after 16 weeks of treatment while also monitoring side effects and exploring resistance mechanisms through tumor and blood sample analyses. Participants receive targeted cancer drugs chosen based on their tumor's genomic profile. The drugs include Alectinib, Atezolizumab, Avelumab, Axitinib, Erlotinib, combinations like Vemurafenib plus Cobimetinib and Trastuzumab plus Pertuzumab, among others. Treatment begins after confirming eligibility for the selected drug, and the study allows proposals for drug use reviewed by a Molecular Tumor Board if needed. Patients are treated with drugs matched to their cancer's genomic markers, with follow-up for toxicity and efficacy. During the study, patients undergo assessments including genomic testing of fresh tumor biopsies and liquid biopsies before and during treatment. Researchers monitor tumor response, progression-free survival, overall survival, treatment duration, and serious side effects. Participation continues under medical supervision, with data collected to understand treatment effects and potential resistance. The trial lasts as long as treatment and follow-up are conducted, involving collaboration across Denmark, the Netherlands, and the USA.

CONDITIONS

Brief Title

ProTarget - A Danish Nationwide Clinical Trial on Targeted Cancer Treatment Based on Genomic Profiling

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older with histologically confirmed locally advanced or metastatic malignant disease
  • No longer benefiting from standard anti-cancer treatment or no suitable standard treatment available
  • ECOG performance status between 0 and 2
  • Acceptable organ function including neutrophil count, hemoglobin, platelets, bilirubin, liver enzymes, and creatinine clearance as defined in the protocol
  • Measurable or evaluable disease by physical or radiographic examination
  • Genomic or protein expression test of tumor performed in an accredited laboratory showing at least one actionable genomic variant
  • Ability to understand and willingness to sign informed consent
  • Tumor genomic profile matches potential clinical benefit from one of the approved targeted therapies in the study
  • Ability to swallow and tolerate oral medications (for orally administered drugs)
  • Agreement to use effective contraception during and after study participation for both women of childbearing potential and men
Not Eligible

You will not qualify if you...

  • Ongoing toxicity greater than grade 2 from prior anti-tumor treatment within 4 weeks, except peripheral neuropathy
  • Previous treatment with the selected study drug for the same cancer
  • Tumor has a genomic variant known to cause resistance to the selected drug
  • Receiving other anti-cancer therapies except certain supportive medications
  • Pregnant or nursing women, or refusal to use effective contraception
  • Progressive brain metastases or unstable neurological status
  • Preexisting uncontrolled cardiac conditions or left ventricular ejection fraction below 40%
  • Stroke or heart attack within 4 months prior to study treatment
  • Acute gastrointestinal bleeding within 1 month prior to treatment
  • Other significant medical conditions that could interfere with study participation
  • Failure to meet drug-specific eligibility criteria
  • Disease not measurable or assessable by imaging or examination
  • Known allergy or hypersensitivity to the study drug or its ingredients

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Until disease progression or unacceptable toxicity

Participants receive targeted anti-cancer drugs matched to a genomic variant identified in their tumor profile. Treatment continues as determined by the physician based on response and tolerance.

Follow-up

Duration - Up to several years until study completion

Participants are monitored for tumor response, progression-free and overall survival, treatment duration, and treatment-related adverse events after ending treatment.

Trial Site Locations

Total: 7 locations

1

Aalborg University Hospital

Aalborg, Aalborg, Denmark, 9000

Not Yet Recruiting

2

Aarhus University Hospital

Aarhus, Aarhus, Denmark, 8200

Not Yet Recruiting

3

Rigshospitalet

Copenhagen, Copenhagen, Denmark, 2100

Actively Recruiting

4

Herlev Hospital

Herlev, Herlev, Denmark, 2730

Not Yet Recruiting

5

Odense University Hospital

Odense, Odense, Denmark, 5000

Not Yet Recruiting

6

Zealand University Hospital

Roskilde, Roskilde, Denmark, 4000

Not Yet Recruiting

7

Vejle Sygehus

Vejle, Vejle, Denmark, 7100

Not Yet Recruiting

Loading map...

Research Team

U

Ulrik Lassen, Prof.

K

Kristoffer S Rohrberg, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

10

Similar Trials

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Published Research Related To This Trial

ProTarget: a Danish Nationwide Clinical Trial on Targeted Cancer Treatment based on genomic profiling - a national, phase 2, prospective, multi-drug, non-randomized, open-label basket trial.

Tina Kringelbach, Martin Højgaard, Kristoffer Rohrberg...

https://pubmed.ncbi.nlm.nih.gov/36814246