Phase 2 Ovarian Cancer Trial, Not Yet Recruiting NCT07714668 Sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd. Condition: Ovarian Cancer
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Phase 2 Ovarian Cancer Trial, Not Yet Recruiting

NCT07714668
Not Yet Recruiting Phase 2

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who fully understand the trial and are willing to sign a consent form voluntarily
  • People aged 18 years or older
  • People who have been confirmed by tissue or cell testing to have high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal cancer
  • People in Cohort A or B: those whose cancer responds to platinum-based chemotherapy, who have had 2 or fewer prior rounds of chemotherapy overall, and — if their cancer has certain gene changes (BRCA mutation or HRD-positive status) — who have already received a type of maintenance treatment called a PARP inhibitor; OR people in Cohort C: those whose cancer does not respond to platinum-based chemotherapy and who have had 3 or fewer prior rounds of chemotherapy overall
  • People whose cancer has gotten worse or who could not tolerate their most recent cancer treatment
  • People whose organs (such as liver, kidneys, and bone marrow) are functioning well enough based on blood and lab tests
  • People who have at least one area of cancer that can be measured on a scan, according to standard measurement guidelines (RECIST v1.1)
  • People with a general health and activity level rated as 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light activity)
  • People who are expected to live for at least 3 more months
  • People who are able to have children (both male and female) and agree to use reliable contraception with their partner(s) throughout the trial and for at least 8 months after the last dose of the study drug

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have previously been treated with a type of drug called a topoisomerase I inhibitor antibody-drug conjugate (ADC) (confirm with trial site)
  • People who have had another cancer in the past 3 years, or who currently have another active cancer — though certain fully treated, localised cancers (such as some skin cancers, early-stage bladder cancer, or carcinoma in situ of the prostate, cervix, or breast) may still be eligible (confirm with trial site)
  • People who have active cancer that has spread to the brain or spinal fluid during the screening period, or who have needed steroid treatment for brain metastases within 28 days before the first dose, or whose cancer involves the brainstem
  • People who still have side effects from previous cancer treatment that have not improved to a mild level (grade 1 or lower), except for certain effects like hair loss that the medical team considers low risk
  • People who have had major surgery within 28 days before starting the trial, or who are expected to need surgery to remove a tumour during the trial
  • People who need folic acid supplements during the screening period
  • People who have taken certain medications that strongly affect how the body processes drugs (strong CYP3A4 inhibitors or inducers) within 14 days before starting the trial, or who would need to keep taking these medications during the trial
  • People with a history of serious bowel or stomach disease
  • People with a history of serious heart disease
  • People with fluid build-up in the chest, abdomen, or around the heart that is difficult to control and has needed frequent draining or medical treatment within 14 days before starting the trial, or that is expected to need further treatment within 2 weeks of a previous procedure
  • People with a history of scarring or inflammation of the lungs (interstitial lung disease or non-infectious pneumonia), those currently needing steroid treatment for a non-infectious lung condition, or those found to have a suspected lung condition of this type during screening
  • People who have had an active serious infection (bacterial, fungal, or viral) requiring intravenous medication within 14 days before starting the trial
  • People with active hepatitis B (based on specific blood test results above set levels) or active hepatitis C (based on specific blood test results above set levels)
  • People with a history of immune system deficiency, or who test positive for HIV during screening
  • People with other conditions that may interfere with their ability to take part safely or that may affect the trial results, such as a history of serious mental illness, drug or substance misuse, or any other significant medical or personal condition (confirm with trial site)

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 29 July 2026

Contact this trial

Phone: 031169085587

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

GP referral letter

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Trial details

Status
Not Yet Recruiting
Phase
Phase 2
Sponsor
CSPC Megalith Biopharmaceutical Co.,Ltd.
Registry
ClinicalTrials.gov
Start date
31 August 2026
Est. completion
30 April 2028

Primary endpoints

The incidence of dose-limiting toxicity (DLT); AEs and SAEs; Recommended Phase 2 Dose (RP2D ); 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: 29 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