BridgeMD
New treatment option for Advanced Solid Tumor
Official title A Beta-only IL-2 ImmunoTherapY Study
ClinicalTrials.gov ID: NCT05086692
What this study is testing
What is MDNA11?
MDNA11 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced solid tumor.
Also referred to as Interleukin-2 (IL-2)-albumin.
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
- This is a Phase 1/2, multi-center, open-label, dose-escalation and expansion study to evaluate safety and tolerability, PK, pharmacodynamic, and early signal of anti-tumor activity of MDNA11 alone or in combination with a checkpoint inhibitor in patients with advanced solid tumors.
- 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
- Aged at least 18 years (inclusive at the time of informed consent).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply...
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
- Demonstrated adequate organ function
You likely can't join if
- Last administration of prior antitumor therapy:
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other...
- Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for...
- Radiation therapy to the lung that is \> 30Gy within 6 months prior to start of treatment.
- Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to...
- Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are...
See the full eligibility criteria
- Aged at least 18 years (inclusive at the time of informed consent).
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
- Must be able and willing to provide written informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.
- Histologically or cytologically confirmed locally advanced or metastatic solid tumor (see tumor types listed under conditions)
- Demonstrated adequate organ function
- Measurable disease as per Response Evaluation Criteria in Solid Tumors, (RECIST v1.1) and documented by CT and/or MRI.
- Life expectancy of ≥ 12 weeks.
- Women of childbearing potential (WOCBP) must have a negative pregnancy test at screening and within 72 hours before the first dose of study drug(s). Women must not be breastfeeding.
- Agree to use highly effective contraception methods. WOCBP must agree to use highly effective birth control. Key
- Last administration of prior antitumor therapy:
- Prior systemic anti-cancer therapy including investigational agents within 4 weeks (could consider shorter interval for kinase inhibitors or other short half-life drugs) prior to start of treatment.
- Prior radiotherapy within 2 weeks prior to start of treatment or has had a history of radiation pneumonitis. A 1-week washout is required for palliative radiation (\<2 weeks of radiotherapy) to non-CNS disease.
- Radiation therapy to the lung that is \> 30Gy within 6 months prior to start of treatment.
- Currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to start of treatment. Concomitant participation in an observational study...
- Has known active CNS metastases and/or carcinomatous meningitis. Patients with previously treated brain metastases may participate provided they are radiologically stable, i.e., without evidence of progression for at...
- Active malignancy (other than the disease under treatment in the study) within the previous 3 years except for curable cancers.
- Condition requiring long-term systemic treatment with either corticosteroids \> 10 mg daily prednisone equivalent or any other form of immunosuppressive therapy within 7 days prior to start of treatment.
- Clinically significant active, known or suspected autoimmune disease, or diseases that can be exacerbated with immunotherapy.
- Severe pulmonary, cardiac or other systemic disease.
- Known hepatitis B or C virus infection.
- Females who are pregnant or lactating or planning to become pregnant during the study.
- Has had an allogeneic tissue/solid organ transplant.
- Active infection requiring systemic therapy.
- Any medical, emotional or psychiatric condition that interfere with the patient's ability to adhere to the protocol
- Any other underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug(s) unsafe or obscure the interpretation of toxicity determination or adverse events.
- Known severe hypersensitivity to any component of study drug(s).
- Inability to comply with study and follow up procedures as judged by the Investigator.
The study team makes the final eligibility decision.
Where it's taking place
- San Diego, California, United States
- San Francisco, California, United States
- Santa Monica, California, United States
- Boca Raton, Florida, United States
- Atlanta, Georgia, United States
- Detroit, Michigan, United States
- Houston, Texas, United States
- Randwick, New South Wales, Australia
- Sydney, New South Wales, Australia
- Buderim, Queensland, Australia
- Greenslopes, Queensland, Australia
- Toronto, Ontario, Canada
- Dublin, Ireland
- Lisbon, Portugal
- Porto, Portugal
- Seoul, Gangnam-gu, South Korea
- Seongnam-si, Gyeonggi-do, South Korea
- Suwon, Gyeonggi-do, South Korea
- Seoul, Jongno-gu, South Korea
- Badalona, Spain
+ 4 more site(s).
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 San Diego, California, United States; San Francisco, California, United States; Santa Monica, California, United States; Boca Raton, Florida, United States; Atlanta, Georgia, United States; Detroit, Michigan, United States and 18 more location(s). 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.