Recurrent or Metastatic MSI-H/dMMR Gynecological MalignanciesPhase 2NCT07738757

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

A Phase 2 study testing Sacituzumab Tirumotecan (Sac-TMT) and Tagitanlimab in people with Recurrent or Metastatic MSI-H/dMMR Gynecological Malignancies, run by Peking Union Medical College Hospital at 2 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Recurrent or Metastatic MSI-H/dMMR Gynecological Malignancies
What is being tested?: Sacituzumab Tirumotecan (Sac-TMT) and Tagitanlimab
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 2 sitesChina
Study dates: 1 Sep 2026to 30 Dec 2029
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
6. Life expectancy more than 12 weeks.

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7. At least one measurable lesion per RECIST 1.1 criteria.
8. Subjects must have recovered from all toxicities related to prior therapies, except for toxicities not considered a safety risk.
9. Adequate function of the important organs.
10. For female subjects of childbearing potential effective medical contraception must be used from the time of signing the informed consent form until 6 months after the last dose of the drug.
11. Participants must voluntarily participate in the study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up assessments.

Who cannot join

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.
5. Subjects diagnosed with active hepatitis B or active hepatitis C.
6. Subjects with known uncontrolled HIV infection.

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7. Subjects with known active tuberculosis.
8. Subjects with documented severe dry eye syndrome, severe meibomian gland dysfunction and/or blepharitis, or a history of corneal disorders that impair or delay corneal healing.
9. Subjects who have undergone major surgery (as defined by the investigator) within 30 days prior to the first dose of study treatment or who have not recovered from prior surgery.
10. Subjects with known hypersensitivity or anaphylaxis to the study drug or its excipients; or a history of severe hypersensitivity reactions to monoclonal antibodies.
11. Subjects with a history of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, currently suffering from ILD/pneumonia, or unable to rule out suspected ILD/pneumonia through imaging at screening.
12. Subjects with a history of allogeneic tissue/organ transplantation.
13. Subjects with autoimmune diseases requiring systemic treatment within the past 2 years or requiring immunosuppressive treatment during the study period. Subjects with controllable type 1 diabetes, thyroiditis with normal thyroid function, or hypothyroidism well controlled by hormone replacement therapy (HRT), or skin diseases (such as vitiligo, psoriasis) that do not require systemic treatment can be included.
14. Subjects who have previously received TROP2-targeted drugs or any therapy containing a topoisomerase I inhibitor, including antibody-drug conjugates (ADCs).
15. Subjects who have previously used any experimental anti-tumor vaccines.
16. Subjects who received live vaccines within 30 days prior to the first dose of study treatment or plan to receive live vaccines during the study.
17. Subjects who need to use strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first study treatment and during the study period.
18. Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy within 4 weeks prior to the first dose of study treatment; subjects who received small molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormone therapy, systemic immunostimulants (including but not limited to interferon, IL-2), or approved anti-tumor Chinese herbal preparations within 2 weeks before the first study treatment.
19. Subjects who received systemic anti-infective treatment within 2 weeks prior to the first dose of study treatment.
20. Pregnant or lactating women.
21. Any other conditions deemed by the investigator to make the patient unsuitable for participation in this study.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Yang Xiang contact

010-69156068

xiangy@pumch.cn

China2 sites

Peking Union Medical College Hospital
Beijing, 100730
Yang Xiang, 010-69156068, xiangy@pumch.cn
Qilu Hospital of Shandong University
Jinan, Shandong, 250012
Beihua Kong, 0531-82168888, kongbeihua@sdu.edu.cn

Other trials in China

About this study

Official title: A Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With Tagitanlimab (KL-A167) as Second-Line or Later Therapy for MSI-H/dMMR Advanced Gynecological Malignancies: An Open-Label, Single-Arm, Multicenter Exploratory 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.

Conditions: Recurrent or Metastatic MSI-H/dMMR Gynecological Malignancies
Being tested: Sacituzumab Tirumotecan (Sac-TMT), Tagitanlimab
Medical subject headings: Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sacituzumab Tirumotecan (Sac-TMT)Drug
Also called SKB264
Sac-TMT will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle.
TagitanlimabDrug
Also called KL-A167
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.

Study groups in NCT07738757
Study group	Role	What they receive
Cohort 1: Endometrial cancer	Experimental	Not described Receives: Drug: Sacituzumab Tirumotecan (Sac-TMT); Drug: Tagitanlimab
Cohort 2: Ovarian cancer & Cervical cancer	Experimental	Not described Receives: Drug: Sacituzumab Tirumotecan (Sac-TMT); Drug: Tagitanlimab

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 24 months

Secondary outcomes (5)

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.
Measured: up to 24 months
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.
Measured: up to 24 months
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.
Measured: up to 24 months
Overall survival(OS)
OS is defined as the time from enrollment to the date of death from any cause.
Measured: up to 5 years
Incidence and severity of adverse events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
Measured: up to 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 202630 Dec 2029

First posted31 Jul 2026
Study start1 Sep 2026 (estimated)
Primary completion1 Sep 2028 (estimated)
Study completion30 Dec 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Recurrent or Metastatic MSI-H/dMMR Gynecological MalignanciesStudies of the same condition, open and under way.
More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 80 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07738757
Sponsor's protocol ID: K10649
Status last verified: Jul 2026
First submitted: 28 Jul 2026
Last updated: 31 Jul 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase II Study of Sacituzumab Tirumotecan (Sac-TMT/SKB264) in Combination With Tagitanlimab (KL-A167) as Second-Line or Later Therapy for MSI-H/dMMR Advanced Gynecological Malignancies: An Open-Label, Single-Arm, Multicenter Exploratory Trial
ClinicalTrials.gov ID: NCT07738757
Acronym / sponsor ID: K10649
Conditions: Recurrent or Metastatic MSI-H/dMMR Gynecological Malignancies
Phase: Phase 2
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 80 participants (estimated)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Study start: 1 Sep 2026 (estimated)
Primary completion: 1 Sep 2028 (estimated)
Study completion: 30 Dec 2029 (estimated)
First posted: 31 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1: Endometrial cancer	Experimental	Drug: Sacituzumab Tirumotecan (Sac-TMT), Drug: Tagitanlimab
Cohort 2: Ovarian cancer & Cervical cancer	Experimental	Drug: Sacituzumab Tirumotecan (Sac-TMT), Drug: Tagitanlimab

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

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.
5. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.

Key exclusion criteria (21 listed)

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.
5. Subjects diagnosed with active hepatitis B or active hepatitis C.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sacituzumab Tirumotecan (Sac-TMT)Also: SKB264Sac-TMT will be administered as an intravenous (IV) infusion every 2 weeks on Day 1 of each 14-day cycle.	Drug	Cohort 1: Endometrial cancer, Cohort 2: Ovarian cancer & Cervical cancer
TagitanlimabAlso: KL-A167KL-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.	Drug	Cohort 1: Endometrial cancer, Cohort 2: Ovarian cancer & Cervical cancer

Primary outcome

Objective response rate(ORR)
Time frame: up to 24 months
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.

5 secondary outcomes

Progression-free survival(PFS)
Time frame: up to 24 months
Duration of response (DoR)
Time frame: up to 24 months
Disease control rate(DCR)
Time frame: up to 24 months
Overall survival(OS)
Time frame: up to 5 years
Incidence and severity of adverse events (AEs)
Time frame: up to 24 months

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Yang Xiang contact

010-69156068

xiangy@pumch.cn

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yang Xiang (010-69156068, xiangy@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate(ORR) (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07738757.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.