Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers (NCT05483933) | Clinical Trial Compass
CompletedPhase 1
Phase 1b Study of SL-172154 Administered With Combination Agent(s) in Subjects With Ovarian Cancers
United States86 participantsStarted 2022-08-18
Plain-language summary
SL03-OHD-105 is an open-label, multicenter, phase 1b trial designed to evaluate SL-172154 administered in combination with pegylated liposomal doxorubicin (PLD) or mirvetuximab soravtansine (MIRV) in patients with platinum resistant ovarian cancer. Approximately 102 patients will be enrolled in this study.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Subject has voluntarily agreed to participate by giving written informed consent in accordance with ICH/GCP guidelines and applicable local regulations.
✓. Age ≥18 years
✓. \[PLD Cohort\] Subject has a histologically confirmed diagnosis of high grade epithelial ovarian cancer, including primary peritoneal cancer or fallopian tube cancer. Non-epithelial tumors and ovarian tumors with low malignant potential are excluded.
✓. \[PLD Cohort\] Subject must have platinum-resistant disease, defined as radiologic disease progression within 180 days (6 months) following the last administered dose of platinum therapy. Subjects who are primary platinum-refractory, defined by progressing during or within 1 month of upfront platinum therapy, are excluded.
✓. \[PLD Cohort\] Subjects may have received any number of prior lines of therapy for epithelial ovarian cancer; however, they may not have received more than 1 prior line of systemic anticancer therapy for platinum-resistant disease.
✓. \[MIRV Cohort\] Subject has a histologically confirmed diagnosis of high grade serous epithelial ovarian cancer, including primary peritoneal cancer or fallopian tube cancer. Non-epithelial tumors and ovarian tumors with low malignant potential are excluded.
✓. \[MIRV Cohort\] Subject must have platinum-resistant disease as defined by:
✓. \[MIRV Cohort\] Subjects must have received at least 1 but no more than 3 prior systemic lines of anticancer therapy.
Exclusion criteria
✕. Prior treatment with a signal-regulatory protein alpha (SIRPα) targeting agent, anti-CD47 agent or CD40 agonist.
What they're measuring
1
Evaluate Safety and Tolerability of SL-172154 When Administered With PLD or Mirvetixumab
Timeframe: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months
2
Establish the Recommended Phase 2 Dose (RP2D) for SL-172154 When Administered With PLD or Mirvetixumab
Timeframe: From Day 1 to 30 days after last dose of SL-172154, PLD or Mirvetixumab, an average of approximately 6 months