SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological Malignancies
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorPeking Union Medical College Hospital
About this trial
This is a prospective, open-label, multicenter, single-arm Phase II study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT/SKB264) in combination with tagitanlimab (KL-A167) as second-line or later therapy in patients with recurrent or metastatic MSI-H/dMMR gynecological malignancies, including endometrial cancer, ovarian cancer, and cervical cancer. The primary objective is to evaluate the objective response rate (ORR) per RECIST v1.1 as assessed by the investigator. Secondary objectives include evaluating overall survival (OS), progression-free survival (PFS) per RECIST v1.1, disease control rate (DCR), duration of response (DoR), and the safety and tolerability of the combination regimen.
Eligibility criteria
Qualifiers
1. Age ≥18 years.
2. Histologically or cytologically confirmed recurrent or metastatic ovarian cancer, endometrial cancer, or cervical cancer.
3. dMMR or MSI-H subtype (defined as: deficiency/loss of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, or MSH6 expression detected by immunohistochemistry (IHC), or identified as MSI-H by polymerase chain reaction (PCR)/next-generation sequencing (NGS)).
4. Received at least 1 prior systemic regimen (prior anti-PD-1/L1 allowed) for recurrent or metastatic ovarian cancer, endometrial cancer, or cervical cancer.
Disqualifiers
1. Subjects with known other malignant tumors that are progressing or require active treatment within the past 3 years.
2. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or other active CNS metastases. Subjects with locally treated brain metastases may participate provided they are clinically stable for at least 4 weeks, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;
3. Subjects with clinically significant cardiovascular diseases.
4. Subjects with severe and/or uncontrolled concomitant diseases, such as uncontrolled hypertension, symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.
Trial design
Treatments tested in this trial
- Sacituzumab Tirumotecan (Sac-TMT)
- Tagitanlimab
Treatment groups
80 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov