Phase 2 Ovarian Cancer Trial, Recruiting (NCT06526819)

Phase 2 Ovarian Cancer Trial, Recruiting NCT06526819 Sponsor: Sumitomo Pharma America, Inc. Condition: Ovarian Cancer

Printed from Voxsanity (voxsanity.com.au) — NCT06526819 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Ovarian Cancer

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:

You have been confirmed by biopsy or lab test to have advanced, returning, or spread cancer that has gotten worse after standard treatment, and no other treatments are available that are likely to help you live longer.
Your cancer is one of the following types: platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer (high-grade); triple negative breast cancer; anal squamous cell carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; or recurrent/persistent uterine serous cancer.
For ovarian cancer: your cancer came back within 6 months of finishing platinum-based chemotherapy.
For triple negative breast cancer: your cancer tests negative for estrogen receptors, progesterone receptors, and HER2.
You are generally able to carry out basic daily activities (your physical functioning level meets a specific medical rating scale score of 2 or less — confirm with trial site).
You have recovered from side effects caused by any previous cancer treatments.
Your blood counts, liver function, and kidney function all meet minimum levels shown in regular blood tests (confirm with trial site for specific numbers).
You agree to use reliable birth control or avoid heterosexual intercourse during the study and for 6 months after your last dose of the study drug.
If you are HIV positive, your immune cell count and virus levels must be within acceptable ranges, and you must have no history of serious HIV-related infections (confirm with trial site).
If you have hepatitis B or C, your virus levels must be below certain limits shown in blood tests (confirm with trial site).

Who may not be able to join:

You have previously been treated with a specific type of cancer drug that targets cell cycle checkpoints (such as CHK1, CHK2, WEE1, or ATR inhibitors).
You have a known allergy or sensitivity to any ingredient in the study drug (SMP-3124LP).
You have received chemotherapy, radiation therapy, or another experimental treatment within the past 14 days (limited palliative radiation within 2 weeks may be allowed — confirm with trial site).
You have had a major operation within the last 28 days, or a minor procedure within the last 7 days.
You have taken certain medications that affect how the body processes drugs (strong CYP1A2 or CYP2D6 inhibitors) within the past 14 days or 5 half-lives, whichever comes first (confirm with trial site for a full list of restricted medications).
Your cancer has spread to your brain or the lining around your brain or spinal cord.
You have or have had another separate cancer that could affect the safety or results of this trial.
You have a significant heart rhythm problem on an ECG, including a specific measurement (QTcF) over 470 milliseconds, or a history of a dangerous heart rhythm condition called Torsade de Pointes.
Your heart's pumping strength is below 45% as measured by an echocardiogram (heart ultrasound).
You have serious heart disease, including significant heart failure.
You have an active, uncontrolled infection (bacterial, viral, or fungal) that requires intravenous antibiotics or antifungals within the past week.
You are currently pregnant or breastfeeding (breastfeeding patients may be able to join if they stop breastfeeding, and do not resume for at least 6 months after their last dose — confirm with trial site).
For ovarian cancer patients: your cancer progressed while you were actually receiving platinum-based chemotherapy (rather than after finishing it), or you had a bowel blockage related to your cancer within the past 3 months.
You have any other medical or mental health condition that the study doctor feels could affect your safety or the trial results.
You are currently taking any medication that is not allowed by this trial (confirm with trial site for the full list).

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 7 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

Principal Investigator: Jian Li, MD, jian.li@us.sumitomo-pharma.com

Phone: 774-405-5069

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT06526819

Sponsor: Sumitomo Pharma America, Inc.

Phase: Phase 2

Status: Recruiting

Condition: Ovarian Cancer

Trial contact: 774-405-5069

More information: https://clinicaltrials.gov/study/NCT06526819

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have been confirmed by biopsy or lab test to have advanced, returning, or spread cancer that has gotten worse after standard treatment, and no other treatments are available that are likely to help you live longer.
Your cancer is one of the following types: platinum-resistant ovarian, fallopian tube, or primary peritoneal cancer (high-grade); triple negative breast cancer; anal squamous cell carcinoma; head and neck squamous cell carcinoma; non-small cell lung cancer; or recurrent/persistent uterine serous cancer.
For ovarian cancer: your cancer came back within 6 months of finishing platinum-based chemotherapy.
For triple negative breast cancer: your cancer tests negative for estrogen receptors, progesterone receptors, and HER2.
You are generally able to carry out basic daily activities (your physical functioning level meets a specific medical rating scale score of 2 or less — confirm with trial site).
You have recovered from side effects caused by any previous cancer treatments.
Your blood counts, liver function, and kidney function all meet minimum levels shown in regular blood tests (confirm with trial site for specific numbers).
You agree to use reliable birth control or avoid heterosexual intercourse during the study and for 6 months after your last dose of the study drug.
If you are HIV positive, your immune cell count and virus levels must be within acceptable ranges, and you must have no history of serious HIV-related infections (confirm with trial site).
If you have hepatitis B or C, your virus levels must be below certain limits shown in blood tests (confirm with trial site).

Who may not be able to join:

You have previously been treated with a specific type of cancer drug that targets cell cycle checkpoints (such as CHK1, CHK2, WEE1, or ATR inhibitors).
You have a known allergy or sensitivity to any ingredient in the study drug (SMP-3124LP).
You have received chemotherapy, radiation therapy, or another experimental treatment within the past 14 days (limited palliative radiation within 2 weeks may be allowed — confirm with trial site).
You have had a major operation within the last 28 days, or a minor procedure within the last 7 days.
You have taken certain medications that affect how the body processes drugs (strong CYP1A2 or CYP2D6 inhibitors) within the past 14 days or 5 half-lives, whichever comes first (confirm with trial site for a full list of restricted medications).
Your cancer has spread to your brain or the lining around your brain or spinal cord.
You have or have had another separate cancer that could affect the safety or results of this trial.
You have a significant heart rhythm problem on an ECG, including a specific measurement (QTcF) over 470 milliseconds, or a history of a dangerous heart rhythm condition called Torsade de Pointes.
Your heart's pumping strength is below 45% as measured by an echocardiogram (heart ultrasound).
You have serious heart disease, including significant heart failure.
You have an active, uncontrolled infection (bacterial, viral, or fungal) that requires intravenous antibiotics or antifungals within the past week.
You are currently pregnant or breastfeeding (breastfeeding patients may be able to join if they stop breastfeeding, and do not resume for at least 6 months after their last dose — confirm with trial site).
For ovarian cancer patients: your cancer progressed while you were actually receiving platinum-based chemotherapy (rather than after finishing it), or you had a bowel blockage related to your cancer within the past 3 months.
You have any other medical or mental health condition that the study doctor feels could affect your safety or the trial results.
You are currently taking any medication that is not allowed by this trial (confirm with trial site for the full list).

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 7 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 2

Sponsor

Sumitomo Pharma America, Inc.

Registry

ClinicalTrials.gov

Start date

14 August 2024

Est. completion

1 December 2028

Where this trial is recruiting

🇯🇵 Japan 🇺🇸 United States

Primary endpoints

Determination of the Recommended Phase 2 Dose by Assessing Dose-limiting Toxicities (DLTs); Number of Participants With Adverse Events and Serious Adverse Events; Determine the Objective Response Rate (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: 7 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