Actively Recruiting
MegaMOST - A Multicenter, Open-label, Biology Driven, Phase II Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations /Characteristics in Advanced / Metastatic Tumors.
Led by Centre Leon Berard · Updated on 2026-04-24
455
Participants Needed
10
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of several matched targeted therapies (MTTs) for patients with advanced or metastatic tumors. This phase II, open-label, multicenter study assigns patients to different treatment groups based on specific molecular alterations found in their tumor samples. The study is designed to be flexible, allowing new treatment groups to open and ineffective ones to close, with treatments continuing as long as patients benefit or until unacceptable side effects or disease progression occur. The treatments being studied include various targeted drugs such as HDM201 combined with Ribociclib, Cabozantinib, Alectinib, Regorafenib, Trametinib alone or with Dabrafenib, and Avapritinib. Dosages and schedules vary by drug, with most given orally either continuously or in cycles. Each treatment group is based on distinct molecular tumor characteristics identified by a multidisciplinary molecular board, ensuring patients receive therapies matched to their tumor's unique genetic profile. Participants will undergo tumor assessments and regular monitoring for safety and response, including radiological scans to measure disease progression according to RECIST criteria. The primary outcome is the progression-free rate after 3 months of treatment, with additional measures including response rates, duration of response, overall survival, and adverse events over up to three years. Patients may continue treatment beyond progression if clinical benefit is observed and conditions permit, with ongoing evaluation by investigators and the sponsor. The study may last several years, with detailed follow-up to assess long-term outcomes.
CONDITIONS
Brief Title
A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged at least 18 years at the time of informed consent.
- Histologically confirmed metastatic or unresectable locally advanced cancer resistant or refractory to standard therapies or without appropriate standard therapies.
- Molecular alterations identified and recommended for specific matched targeted therapy by a multidisciplinary molecular board.
- Previously treated with at least one prior treatment line for advanced/metastatic cancer, except certain tumor types without approved standard treatments.
- Documented radiological disease progression per RECIST v1.1 with at least one measurable lesion.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ and cardiovascular function.
- Toxicities from prior cancer treatments resolved to grade 1 or less, except for certain specified conditions.
- Men must use effective contraception unless infertile.
- Women of child-bearing potential must have a negative pregnancy test within 7 days before first study drug dose and use effective contraception.
- Ability and willingness to understand, sign informed consent, and comply with study procedures.
- Medical insurance coverage.
You will not qualify if you...
- Patients eligible for curative therapy.
- Participation in another clinical trial with a medicinal product.
- Prior treatment with similar matched targeted therapies targeting the same pathways.
- Inability to swallow oral medications.
- Known hypersensitivity to study drug components.
- Symptomatic or unstable central nervous system metastases requiring increasing corticosteroids or local therapy.
- Secondary malignancies expected to interfere with study evaluation unless approved by sponsor.
- Use or required use of prohibited medications or not respecting wash-out periods.
- Clinically significant or uncontrolled medical conditions that may interfere with study tolerance or results.
- Psychiatric or substance abuse disorders interfering with trial cooperation.
- Pregnancy, breastfeeding, or plans to conceive/father children during the study period and follow-up.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years or until disease progression or discontinuation
Participants receive targeted anti-cancer drug treatments based on their tumor molecular alterations. Treatment is given orally with schedules varying by drug regimen.
Visits every 3 weeks coinciding with treatment cycles
Duration - Up to 3 years
Participants are monitored for long-term outcomes including progression-free survival, overall survival, response duration, and adverse events after treatment ends.
Regular follow-up visits for up to 3 years
Trial Site Locations
Total: 10 locations
1
Institut Bergonié
Bordeaux, France, 33076
Actively Recruiting
2
Centre François Baclesse
Caen, France, 14076
Actively Recruiting
3
Centre Léon Bérard
Lyon, France, 69373
Actively Recruiting
4
Institut Paoli Calmettes
Marseille, France, 13273
Actively Recruiting
5
Centre Antoine LACASSAGNE
Nice, France, 06189
Actively Recruiting
6
Institut Curie
Paris, France, 75248
Not Yet Recruiting
7
Institut de Cancérologie de Strasbourg
Strasbourg, France, 67033
Terminated
8
CHU Strasbourg - Hôpital de Hautepierre
Strasbourg, France, 67098
Actively Recruiting
9
Institut Claudius Regaud
Toulouse, France, 31059
Actively Recruiting
10
Institut Gustave Roussy
Villejuif, France, 94805
Actively Recruiting
Research Team
J
Jean-Yves BLAY, MD
O
Olivier TREDAN, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
7
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