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OncoMatch/Clinical Trials/NCT05465941

PLX038 for Treatment of Metastatic Platinum-resistant Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Is NCT05465941 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pegylated SN-38 Conjugate PLX038 for platinum-resistant fallopian tube carcinoma.

Phase 2RecruitingMayo ClinicNCT05465941Data as of May 2026

Treatment: Pegylated SN-38 Conjugate PLX038This phase II trial tests whether pegylated SN-38 conjugate PLX038 (PLX038) works to shrink tumors in patients with ovarian, primary peritoneal, and fallopian tube cancers that has spread from where it first started (primary site) to other places in the body (metastatic). PLX038 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

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Extracted eligibility criteria

Cancer type

Ovarian Cancer

Disease stage

Required: Stage IV

Metastatic disease required

Grade: high grade

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 1 prior line

Cannot have received: chemotherapy

Exception: allowed if >4 weeks prior to registration

Chemotherapy =< 4 weeks prior to registration

Cannot have received: immunotherapy

Exception: allowed if >4 weeks prior to registration

Immunotherapy =< 4 weeks prior to registration

Cannot have received: radiotherapy

Exception: allowed if >4 weeks prior to registration

Radiotherapy =< 4 weeks prior to registration

Cannot have received: investigational therapy

Exception: allowed if >4 weeks prior to registration

Any other investigational therapy =< 4 weeks prior to registration

Lab requirements

Blood counts

Hemoglobin >= 8.0 g/dL; ANC >= 1500/mm^3; Platelet count >= 100,000/mm^3

Kidney function

Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula

Liver function

Total bilirubin >= 1.5 x ULN; ALT and AST <= 3 x ULN (<= 5 x ULN for patients with liver involvement)

Cardiac function

No myocardial infarction within 6 months; NYHA class IIB or better; QTc <= 480 msec (Fridericia) if prior doxorubicin (Doxil)

Hemoglobin >= 8.0 g/dL; ANC >= 1500/mm^3; Platelet count >= 100,000/mm^3; Total bilirubin >= 1.5 x ULN; ALT and AST <= 3 x ULN (<= 5 x ULN for patients with liver involvement); Calculated creatinine clearance >= 45 ml/min using the Cockcroft-Gault formula; NYHA class IIB or better; QTc <= 480 msec (Fridericia) if prior doxorubicin (Doxil)

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • Mayo Clinic · Rochester, Minnesota

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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