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SKB264 Plus KL-A167 in MSI-H/dMMR Advanced Gynecological Malignancies

ConditionRecurrent or Metastatic MSI-H/dMMR 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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Sacituzumab Tirumotecan (Sac-TMT)

    Drug

    Sac-TMT will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle.

  • Tagitanlimab

    Drug

    KL-A167 will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle. KL-A167 therapy for up to 2 years.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Cohort 1: Endometrial cancerExperimental treatment 2 interventions
Group B: Cohort 2: Ovarian cancer & Cervical cancerExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Objective response rate(ORR)

Ãbjective Response Rate (ÃRR) is the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR). assessed byInvestigator based on RECiST version 1.1.

Time frame
up to 24 months

Secondary outcomes

1

Progression-free survival(PFS)

Progression-free survival (PFS) was defned as the time from baseline to the earliest date of the frst objective documentation of progressive disease (PD) or death due to any cause. PD was defined as at least a 20% increase in the sum of diameters of target lesions.

Time frame
up to 24 months
2

Duration of response (DoR)

Duration of Response (DOR) was defined as the time from the date of the first documentation of objective response (complete response \[CR\] or partial response lPR\]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR was measured for responding subjects (PR or CR) only.

Time frame
up to 24 months
3

Disease control rate(DCR)

Disease control rate (DCR) was defined as the sum of complete response (CR) rate, partial response (PR) rate, and stable disease (SD) rate. As per RECIST v1,1,CR was defined as a disappearance of all target lesions, PR was defined as at least a 30% decrease in the sum of diameters of target lesions, and stable disease (SD) was defned as neither suffcient shrinkage to qualify for PR nor suffcient increase to qualify for progressive disease (PD; at least a 20% increase in the sum of diameters of target lesions.

Time frame
up to 24 months
4

Overall survival(OS)

OS is defined as the time from enrollment to the date of death from any cause.

Time frame
up to 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking Union Medical College Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: