Phase 2 Ovarian Cancer Trial, Recruiting NCT05867251 Sponsor: Avenzo Therapeutics, Inc. Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Recruiting

NCT05867251
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 who have a good general level of physical functioning (rated 0 or 1 on a standard oncology scale, meaning fully active or able to carry out light activities)
  • People with certain advanced or spread cancers, depending on which part of the trial they would be enrolled in — including hormone receptor-positive, HER2-negative breast cancer; ovarian, peritoneal, or fallopian tube cancer; endometrial cancer; or triple-negative breast cancer (TNBC) — where specific genetic features or prior treatment history may apply (confirm with trial site for which group applies)
  • People whose cancer has a specific genetic change called CCNE1 amplification, for certain parts of the trial
  • People with breast cancer who have previously been treated with a type of drug called a CDK4/6 inhibitor and hormone therapy, for certain parts of the trial
  • People with ovarian, peritoneal, or fallopian tube cancer whose cancer has stopped responding to platinum-based chemotherapy, for certain parts of the trial
  • People who have had no more than 2 prior chemotherapy treatments for advanced or spread disease (with some exceptions depending on cancer type and treatment history — confirm with trial site)
  • People whose cancer can be measured on standard scans
  • People with adequate blood counts and organ function
  • People who are able to swallow capsules or tablets

Who may not be able to join:

  • People who have received another experimental treatment or cancer therapy within the past 2 weeks, or within 5 half-lives of that drug (whichever is shorter) before the planned trial start date
  • People who have previously been treated with a CDK2 inhibitor, a PKMYT1 inhibitor, or a WEE1 inhibitor (and for one specific group in the trial, prior treatment with a type of drug called a topoisomerase inhibitor is also not permitted)
  • People who have had major surgery within 4 weeks before the planned trial start date
  • People who have received radiation therapy for symptom relief within 7 days before the first dose of the trial treatment (unless otherwise specified)
  • People who have active, spreading cancer in the brain or surrounding tissue (active brain metastases or leptomeningeal disease)
  • People who still have significant side effects from previous cancer treatments that have not resolved
  • People with clinically unstable heart function (confirm with trial site for specific details)
  • People with an active or ongoing infection or disease that affects how the immune system works
  • People currently taking certain medications that strongly or moderately affect how the body processes drugs (known as CYP3A4 inhibitors or inducers — confirm with trial site)
  • People with another active cancer, unless it has been in remission for long enough and approval has been granted by the trial sponsor
  • People who are pregnant, breastfeeding, or planning to breastfeed during the trial or within 6 months of the last dose of the trial treatment

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 23 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: (858) 239-2944

Australian sites

Macquarie University Hospital, Macquarie University, New South Wales
Cancer Care Wollongong, Wollongong, New South Wales

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
Avenzo Therapeutics, Inc.
Registry
ClinicalTrials.gov
Start date
30 August 2023
Est. completion
31 January 2028

Where this trial is recruiting

🇦🇺 Australia 🇺🇸 United States

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

Primary endpoints

Occurrence of Dose Limiting Toxicities (DLTs) during the first cycle (Phase 1); Number of Participants with Treatment Emergent Adverse Events (TEAEs) and lab abnormalities (Phase 1); Determination of Recommended Phase 2 Dose (RP2D) (Phase 1); Objective Response Rate (ORR) (Phase 2); Progression Free Survival (PFS) (Phase 2); Overall Survival (OS) (Phase 2); Duration of response (DOR) (Phase 2)

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: 23 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