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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT06238687

NCT06238687
Completed Phase 2

Who may be able to join

Who might be able to join this trial:

  • Doctors expect you to live for more than 3 months.
  • You have at least one area of cancer that can be measured on a scan, and it is not in an area that has been treated with radiation.
  • Any side effects from your previous cancer treatments have mostly gone away (back to mild or no symptoms).
  • Your blood counts and organ functions (such as liver and kidneys) are at acceptable levels (confirm with trial site).
  • A heart tracing test (ECG) shows your heart's electrical activity is within a safe range.
  • (For the general dose-finding part of the trial): Your cancer has come back or gotten worse after at least one standard treatment, or no standard treatment is available or suitable for you.
  • (For the specific cancer group part of the trial — Cohorts A & B): You have been diagnosed with high-grade serous ovarian cancer, fallopian tube cancer, or primary peritoneal carcinoma.
  • (Cohort C): You have been diagnosed with a specific type of endometrial (womb lining) cancer, it has come back or worsened after at least one course of platinum-based chemotherapy or immunotherapy, and you have had no more than 3 previous treatment courses.
  • (Cohort D): You have advanced or metastatic non-small-cell lung cancer that cannot be removed by surgery, and your previous treatments meet specific requirements depending on whether you have certain genetic mutations (confirm with trial site).
  • (Cohort E): You have advanced or metastatic breast cancer that cannot be removed by surgery, and your cancer tests negative for ER, PR, and HER-2 receptors (sometimes called "triple-negative breast cancer"), and you have had at least 1 but no more than 4 previous systemic cancer treatments.

Who may not be able to join:

  • You have previously been treated with certain antibody-drug combinations (called ADCs) that target a specific part of cancer cells using tubulin inhibitors (confirm with trial site for specific drug names).
  • You have previously received any treatment that specifically targets a protein called FolRα.
  • You have had a severe allergic reaction to a monoclonal antibody therapy or a related treatment in the past.
  • You have received certain cancer treatments too recently — for example, chemotherapy within the last 3 weeks, certain targeted drugs within 2 weeks, other antibody treatments within 3 weeks, or radiation or major surgery within 4 weeks (confirm with trial site for full details).
  • You have a significant existing eye condition, such as corneal disease, a history of corneal transplant, uncontrolled glaucoma, macular degeneration, diabetic eye disease, cataracts causing vision problems, dry eye disease, or other serious eye conditions.
  • You need to regularly take folic acid (folate) supplements, for example because of a folate deficiency.

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.

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.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Tasly Pharmaceutical Group Co., Ltd
Registry
clinicaltrials_gov
Start date
8 November 2023
Est. completion
6 June 2025

Where this trial is recruiting

🇨🇳 China

Primary endpoints

DLT Assessment; AE Assessment; AUC; Cmax; Half life (t1/2); Overall response rate (ORR); Determine the recommended phase II dose (RP2D)

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov