OncoMatch/Clinical Trials/NCT04116541
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.
Is NCT04116541 recruiting? Yes, currently enrolling (Jul 2026). This Phase 2 trial studies multiple treatments for malignant solid tumor.
Treatment: HDM201 · Ribociclib · Cabozantinib · Alectinib · Regorafenib · Trametinib · Dabrafenib · Avapritinib — This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment. Patients will be assigned to a treatment cohort based on molecular alterations/characteristics detected on tumor sample from primary tumor or metastatic lesion. In this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced/metastatic cancers. All eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent. Patients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor: * Evidence of clinical benefit as assessed by the investigators, * Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease, * No decline in ECOG Performance Status (PS) that can be attributed to disease progression.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Tumor Agnostic
Biomarker criteria
Required: ALK activating rearrangement
Required: ALK selected mutations
Required: ALK translocation
Required: AXL activating mutation
Required: AXL amplification
Required: BRAF activating mutation
Required: BRAF amplification
Required: BRAF amplification
Required: BRAF rearrangement
Required: BRAF rearrangement
Required: BRAF translocation
Required: BRAF v600 mutation
Required: CCND1 amplification
Required: CCND3 amplification
Required: CDK4 amplification
Required: CDK6 amplification
Required: CDKN2A homozygous deletion
Required: CRAF activating mutation
Required: CSF1R activating mutation
Required: FGFR1 activating mutation
Required: FGFR2 activating mutation
Required: FLT3 activating mutation
Required: HRAS activating mutation
Required: HRAS activating mutation
Required: KIT activating mutation
Required: KIT activating mutation exon 17
Required: KIT mutation exon 11
Required: KRAS activating mutation (except all kras g12 mutations)
Required: KRAS amplification (except all kras g12 mutations)
Required: MAP2K activating mutation
Required: MER activating mutation
Required: MER amplification
Required: MET activating mutation
Required: MET amplification
Required: MET translocation
Required: NF1 biallelic inactivation
Required: NRAS activating mutation
Required: NTRK1 translocation
Required: NTRK2 translocation
Required: NTRK3 translocation
Required: PDGFRA activating mutation
Required: PDGFRA activating mutation exon 18
Required: PDGFRA mutation exon 12
Required: PDGFRA mutation exon 14
Required: PTPN11 activating mutation
Required: RAF1 activating mutation
Required: RAF1 translocation
Required: RB1 no deletion/losses more than single copy by copy number
Required: RET activating mutation
Required: RET activating mutation
Required: RET translocation
Required: ROS1 activating mutation
Required: ROS1 amplification
Required: ROS1 translocation
Required: SMAD4 biallelic inactivation
Required: TIE2 activating mutation
Required: TIE2 activating mutation
Required: TIE2 amplification
Required: TP53 wild-type
Required: TRKB activating mutation
Required: TYRO3 activating mutation
Required: VEGF activating mutation
Required: VEGF amplification
Required: VEGFR activating mutation
Required: VEGFR amplification
Required: VEGFR1 activating mutation
Required: VEGFR2 activating mutation
Required: VEGFR3 activating mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy for advanced/metastatic disease — advanced/metastatic
Cannot have received: agent targeting the same signaling pathways components
Lab requirements
Blood counts
adequate organ function
Kidney function
adequate organ function
Liver function
adequate organ function
Cardiac function
adequate cardiovascular function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT04116541 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior agent targeting the same signaling pathways components disqualifies patients from enrollment.
Does this trial require ALK?
Yes, ALK activating rearrangement is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK selected mutations is a required biomarker for enrollment.
Does this trial require ALK?
Yes, ALK translocation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify