BridgeMD
New treatment option for Mesothelioma
Official title A 2-part Phase 1/2 Open-label Trial on ODM-212
ClinicalTrials.gov ID: NCT07563738
What this study is testing
What is ODM-212?
ODM-212 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for mesothelioma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- An open-label, multi-site, multi-cohort phase 1/2 trial to be conducted in 2 parts (dose escalation and dose expansion/optimisation)
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female participants ≥18 years old.
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Life expectancy of \>12 weeks, in the opinion of the investigator.
- Ability to take oral medications and willing to record daily adherence to investigational product.
- Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to...
You likely can't join if
- Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in...
- Prior chemotherapy, immunotherapy (immune checkpoint inhibitor, tumour vaccine, cytokine or growth factor given to control the cancer) or other...
- Any persistent unresolved toxicity from previous anti-cancer therapies of CTCAE Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine...
- Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before trial treatment...
- Participants with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and have been adequately treated with local...
- Any severe active infection within 1 week of trial enrolment.
See the full eligibility criteria
Who can join
- Male or female participants ≥18 years old.
- Performance status 0-1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale.
- Life expectancy of \>12 weeks, in the opinion of the investigator.
- Ability to take oral medications and willing to record daily adherence to investigational product.
- Part 1: Participants with histologically or cytologically confirmed advanced or metastatic, unresectable solid tumors and who are able and willing to receive one of the anti-cancer therapies studied in this trial...
- Arm A: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive treatment with ipilimumab/nivolumab; participants must not...
- Arm B: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive treatment with nab-paclitaxel and gemcitabine.
- Arm C: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who have received the available 1st line...
- Ipilimumab/nivolumab cohort: Participants with histologically or cytologically confirmed diagnosis of advanced (unresectable or metastatic) mesothelioma who are eligible to receive a treatment with ipilimumab/nivolumab...
- Nab-paclitaxel/gemcitabine cohort: Participants with histologically or cytologically confirmed metastatic adenocarcinoma of the pancreas who are eligible to receive a treatment with nab-paclitaxel and gemcitabine...
- Sotorasib cohort, treatment naïve: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C-mutation, confirmed using a validated test, who are...
- Sotorasib cohort, pretreated: Participants with histologically or cytologically confirmed diagnosis of locally advanced or metastatic NSCLC and a KRAS G12C mutation, confirmed using a validated test, who have documented...
- Part 2 only: Participants must have measurable disease by response evaluation criteria in solid tumours (RECIST) v. 1.1 (modified RECIST for MPM).
- A recent (taken up to 1 year ago), representative tumour tissue sample (from primary tumour or from metastasis) must be available. Tissue must be a core needle biopsy, excisional or incisional biopsy. Biopsies of bone...
- Amenable for paired fresh tumour biopsy at screening period and on-treatment.
What rules you out
- Other malignancy active within the previous 2 years except for basal cell or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast, for which the participants has completed...
- Prior chemotherapy, immunotherapy (immune checkpoint inhibitor, tumour vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 2 weeks before trial treatment...
- Any persistent unresolved toxicity from previous anti-cancer therapies of CTCAE Grade ≥ 2 (except for peripheral neuropathy, alopecia, endocrine disorders that are controlled with replacement hormone therapy and...
- Prior definitive radiation therapy within less than 4 weeks and prior palliative radiotherapy within less than 2 weeks before trial treatment administration. Radiopharmaceuticals should be expected to have cleared...
- Participants with brain or subdural metastases are not eligible, unless the metastases are asymptomatic and have been adequately treated with local therapy.
- Any severe active infection within 1 week of trial enrolment.
- Known positive tests for hepatitis B surface antigen or hepatitis C virus (HCV) RNA; known human immunodeficiency virus (HIV) infection. Screening test is not required unless participant has clinical findings suggestive...
- Major surgery within 4 weeks before the first dose of trial treatment or minor surgery within 1 week (participant must also have recovered from any surgery-related toxicities to less than CTCAE Grade 2).
- Immunosuppressive doses of systemic medications, such as steroids or absorbed topical steroids (doses \>10 mg/day prednisone or equivalent) within 2 days before trial treatment administration.
- Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g. nausea, diarrhoea, or vomiting) that might impair the bioavailability of ODM-212.
- Use of other investigational medicinal products within 2 weeks or at least 5 half-lives (whichever is longer) before trial treatment administration, or any persistent unresolved toxicity from such treatment that...
- Use of any live or live-attenuated vaccines (e.g., intranasal influenza, measles, mumps, rubella, shingles, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dose of...
- Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG; e.g., complete left bundle branch block, third degree heart block, second degree heart block, PR interval \>250 ms, a prolonged...
- Significant cardiovascular impairment: history of congestive heart failure of New York Heart Association (NYHA) Class III-IV, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke, left...
- Female participants who are breastfeeding or pregnant at screening or baseline. A separate baseline assessment for pregnancy is required if a negative screening pregnancy test was obtained more than 72 hours before the...
The study team makes the final eligibility decision.
Where it's taking place
- Irving, Texas, United States
- Fairfax, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irving, Texas, United States; Fairfax, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.