Phase 2 Breast Cancer Trial, Recruiting NCT06827613 Sponsor: Marengo Therapeutics, Inc. Condition: Breast Cancer
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Phase 2 Breast Cancer Trial, Recruiting

NCT06827613
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who have cancer that can be measured on a CT scan and/or MRI, or measured with calipers if the tumour is on or just under the skin
  • People with triple-negative breast cancer (TNBC) that has spread or come back, either locally or to other parts of the body
  • People with hormone receptor-positive, HER2-negative breast cancer (HR+/HER2-) that has spread or come back, either locally or to other parts of the body
  • People who have cancer that has spread to the brain, provided it has already been treated, they have had no symptoms for at least 14 days, they are not currently receiving any treatment for the brain cancer (such as surgery, radiation, or higher-dose steroids), and there is no cancer affecting the spinal fluid or causing spinal cord compression

Who may not be able to join:

  • People with a history of most autoimmune diseases — though some conditions may still be acceptable, including vitiligo, psoriasis, eczema or other skin autoimmune conditions not needing systemic treatment, well-controlled thyroid conditions (such as Graves' disease that has been stable for more than 4 weeks, or hypothyroidism managed with thyroid replacement), hair loss (alopecia), arthritis managed only with over-the-counter anti-inflammatory tablets, and well-controlled adrenal insufficiency on replacement therapy (confirm with trial site)
  • People who have had major surgery or a serious injury within 8 weeks before the first treatment in the study
  • People whose surgical or injury wounds have not fully healed
  • People with significant heart or blood vessel disease, stomach or bowel problems, active inflammatory conditions, or serious lung problems (confirm with trial site for specific definitions)
  • People who have an active serious infection (viral, bacterial, or fungal) that required treatment given through a drip or injection within 7 days before starting the study treatment
  • People who have received a live virus vaccine within 4 weeks before starting the study treatment — standard inactivated flu vaccines are allowed
  • People who are HIV positive, or hepatitis B or C positive, with disease that is not well controlled
  • People who have had a second cancer that has not been in remission for at least 1 year — some exceptions may apply, such as certain skin cancers, early-stage cervical changes, low-risk localised prostate cancer, or some slow-growing cancers that have never needed systemic treatment (confirm with trial site)
  • People who are pregnant, likely to become pregnant, or who are breastfeeding
  • People who have taken more than 10 mg per day of prednisone (or an equivalent steroid) or other immune-suppressing medications within 7 days before starting the study treatment — topical, eye drop, inhaled, or nasal steroid preparations are generally allowed

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 8 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 617-276-5734

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Marengo Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
24 March 2025
Est. completion
1 January 2027

Where this trial is recruiting

🇨🇦 Canada 🇺🇸 United States

Primary endpoints

Phase 1 (Safety Run-In): Number of Participants with Dose Limiting Toxicites (DLTs); Phase 1 and 2 (Safety Run-In and Cohort Expansion): Number of Participants with Adverse Events and Serious Adverse Events; Phase 1 and 2 (Safety Run-In and Cohort Expansion): Percentage of participants with Overall Objective Tumor Responses (ORR)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 8 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov