A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

Summary

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.

Conditions

• Malignant Solid Tumor

Interventions

DRUG

HDM201

HDM201 120mg, Every 3 weeks, Per os

DRUG

Ribociclib

Ribociclib 200mg/day, once daily 2 weeks on/1 week off, Per os

DRUG

Cabozantinib

Cabozantinib, 60 mg /day, continuous, Per os

DRUG

Alectinib

Alectinib, 600mg twice daily, Per os

DRUG

Regorafenib

Regorafenib 160mg, once daily, 3 weeks on/1 week off, Per os

DRUG

Trametinib

Trametinib 2 mg/day, continuous, Per os

DRUG

Dabrafenib

Dabrafenib 150 mg twice daily, Per os

DRUG

Avapritinib

300 mg/day,continuous, Per os

Sponsors & Collaborators

• Centre Leon Berard

  lead OTHER

Principal Investigators

• Jean-Yves BLAY, MD · Centre Leon Berard

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-01-28

Primary Completion

2026-10-31

Completion

2027-10-31

Countries

• France

Study Locations