Phase 2 Ovarian Cancer Trial, Recruiting NCT06953089 Sponsor: DualityBio Inc. Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT06953089
Recruiting Phase 2 🇦🇺 Australian site

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:

  • Adults aged 18 or older (or the minimum age allowed by local rules) who are willing to voluntarily sign a consent form.
  • People who have at least one tumour that can be measured using standard imaging assessment methods.
  • People with a life expectancy of at least 3 months.
  • People who are generally able to carry out daily activities with little or no limitation (a standard performance scale rating of 0 or 1 is used to measure this — confirm with trial site if unsure what this means).
  • People whose organs (such as kidneys and liver) are functioning adequately, confirmed by tests done within 7 days before joining the trial.
  • People who have had enough time since their last cancer treatment before starting this trial (the required gap depends on the treatment type — confirm with trial site).
  • People with liver cancer (HCC) who have a confirmed diagnosis and whose liver function falls within a specific scoring range (Child-Pugh class A).
  • People with cervical cancer that has persisted, come back, or spread, with specific cell types (squamous cell, adenocarcinoma, or adenosquamous).
  • People with melanoma that cannot be surgically removed and is at an advanced or metastatic stage, confirmed by tissue or cell testing.
  • People with a confirmed diagnosis of ovarian cancer, primary peritoneal cancer, or fallopian tube cancer — all of a specific type (high-grade serous) — where the cancer has stopped responding to platinum-based chemotherapy (confirm with trial site).
  • People with head and neck cancer (of the mouth, throat, voice box, or related areas) that has come back or spread and cannot be cured with local or other treatments, confirmed by tissue or cell testing.
  • People with advanced lung cancer (non-small cell, stage IIIB, IIIC, or IV) that is not suitable for surgery or certain combined treatments, and whose cancer does not carry specific gene changes (EGFR, ALK, or other driver mutations).
  • People with ovarian, peritoneal, or fallopian tube cancer that came back more than 6 months after completing platinum-based chemotherapy, confirmed by imaging.
  • People with pancreatic cancer that has spread (metastatic), confirmed by tissue or cell testing, and who have already received at least one prior standard treatment.
  • People with hormone receptor-positive (HR+) breast cancer that cannot be surgically removed or has spread, with varying levels of HER2 expression (low, ultralow, or negative), confirmed by tissue or cell testing.
  • People with triple negative breast cancer (TNBC) that cannot be surgically removed or has spread, confirmed by tissue or cell testing.
  • People with colorectal cancer that has spread and has progressed after one or two prior treatment regimens, depending on whether targeted therapy was previously received.
  • People with prostate cancer that has spread and is no longer responding to hormone therapy (metastatic castration-resistant prostate cancer), confirmed by tissue or cell testing.

Who may not be able to join:

  • People who have previously received a treatment that specifically targets the B7H3 protein.
  • People who have previously received a type of drug called an antibody-drug conjugate that uses a topoisomerase inhibitor.
  • People whose cancer may be treatable with a local procedure that could result in a complete or near-complete response, as judged by the treating doctor.
  • People with other serious illnesses that are not well controlled and that could interfere with trial participation or increase safety risks.
  • People with significant heart or blood vessel disease that is not well controlled.
  • People with uncontrolled fluid build-up around the lungs, in the abdomen, or around the heart that requires procedures to drain or manage it.
  • People with a history of lung inflammation (a condition affecting the lung tissue, not caused by infection).
  • People with autoimmune, connective tissue, or inflammatory conditions.
  • People with spinal cord compression or brain/central nervous system spread of cancer that is currently causing symptoms.
  • People who still have significant side effects from previous cancer treatments that have not resolved (side effects must generally have settled back to a mild level or to the person's baseline, except for hair loss).

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 22 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: 540-808-3925

Australian sites

AUS07-0, North Sydney, New South Wales
AUS06-0, Benowa, Queensland
AUS04-0, Birtinya, Queensland
AUS05-0, Adelaide, South Australia

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
DualityBio Inc.
Registry
ClinicalTrials.gov
Start date
18 July 2025
Est. completion
30 June 2030

Where this trial is recruiting

🇦🇺 Australia 🇨🇳 China 🇹🇼 Taiwan 🇺🇸 United States

4 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Part 1: Number of participants with Dose Limiting Toxicities (DLTs).; Part 1: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs); Part 2: Treatment-emergent adverse events (TEAEs) and treatment-emergent serious AE (TESAEs) [By arm and dose level]; Part 2: Objective response rate (ORR), defined as the proportion of participants in whom a confirmed Complete response (CR) or PR is observed as best overall response (per RECIST 1.1 based on the investigator's assessment)by arm and dose level.

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: 22 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