NCT05797831 Study of Navtemadlin as Maintenance Therapy in TP53WT Advanced or Recurrent Endometrial Cancer
| NCT ID | NCT05797831 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Kartos Therapeutics, Inc. |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 268 participants |
| Start Date | 2023-07-17 |
| Primary Completion | 2025-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 268 participants in total. It began in 2023-07-17 with a primary completion date of 2025-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study evaluates navtemadlin as maintenance treatment for patients with advanced or recurrent endometrial cancer (EC) who have achieved complete response or partial response on chemotherapy. The study will be conducted in 2 parts. Part 1 will evaluate safety and efficacy of two different doses of navtemadlin alongside an observational control arm to determine the Phase 3 navtemadlin dose. Part 2 will evaluate the efficacy and safety of navtemadlin Phase 3 dose compared to placebo.
Eligibility Criteria
Inclusion Criteria: * ECOG 0-1 * Histologically or cytologically confirmed diagnosis of endometrial cancer documented as TP53WT * Subjects with advanced or recurrent disease must have completed a single line of up to 6 cycles of taxane-platinum based chemo and achieved a CR or PR per RECIST V1.1 * Adequate hematologic, hepatic and renal function (within 14 days) Exclusion Criteria: * Has any sarcomas or small-cell carcinomas with neuroendocrine differentiation * Prior immune therapy, cytokine therapy, or any investigational therapy (within 28 days) * Indwelling surgical drains * Grade 2 or higher QTc prolongation * History of major organ transplant * History of bleeding diathesis; major hemorrhage or intracranial hemorrhage (within 24 weeks)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05797831 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05797831 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05797831 currently recruiting?
Yes, NCT05797831 is actively recruiting participants. Contact the research team at jmei@kartosthera.com for enrollment information.
Where is the NCT05797831 trial being conducted?
This trial is being conducted at Vallejo, United States, Atlanta, United States, Savannah, United States, Hinsdale, United States and 11 additional locations.
Who is sponsoring the NCT05797831 clinical trial?
NCT05797831 is sponsored by Kartos Therapeutics, Inc.. The trial plans to enroll 268 participants.
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