Epithelial Ovarian CancerPhase 1NCT07674615
IMMU-132 in TROP-2 Overexpressed Advanced and Relapsed Ovarian Cancer
A Phase 1 study testing Sacituzumab govitecan monotherapy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancers, run by Shanghai Gynecologic Oncology Group at 1 site in China.
Trial summary
To observe the efficacy and safety of IMMU-132 in patients with advanced or recurrent ovarian cancer with high TROP-2 expression in tumor tissue, who have failed standard therapy or are unable to receive standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Epithelial Ovarian Cancer, Fallopian Tube Cancers, Primary
- What is being tested?
- Sacituzumab govitecan monotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 30 Jun 2027
- Phase
- Phase 1
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years and ≤ 80 years;
- Histologically confirmed advanced or recurrent high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer;
- Recurrent patients meeting one of the following two conditions:
- Disease recurrence or progression after at least one prior platinum-based chemotherapy regimen, with disease progression occurring less than 6 months from the last dose of platinum-based chemotherapy;
- Disease recurrence or progression after at least three prior platinum-based chemotherapy regimens, with disease progression occurring ≥ 6 months from the last dose of platinum-based chemotherapy, and who are unable to receive standard platinum-based chemotherapy;
- Patients with advanced epithelial ovarian cancer presenting with hematogenous metastasis, who are unable to receive standard treatment, with an estimated life expectancy of more than 3 months but approximately not exceeding 12 months with current therapy;
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- Have measurable disease per RECIST 1.1 criteria (Appendix A) or diagnosis of recurrence/disease progression per GCIG criteria;
- Known BRCA (Breast Cancer Gene) and HRD (Homologous Recombination Deficiency) status;
- Have available paraffin-embedded or fresh tumor tissue for TROP-2 testing;
- Tumor tissue TROP-2 H-score > 200;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
- Adequate bone marrow hematopoietic function and organ function, allowing the patient to receive treatment;
- Patients must have had at least a 2-week interval from prior therapy (chemotherapy, investigational agents including small molecule inhibitors, endocrine therapy, immunotherapy, and/or radiotherapy) or major surgery;
- Patients must have had at least a 2-week interval from high-dose systemic corticosteroids (however, low-dose corticosteroids < 20 mg prednisone or its equivalent are permitted);
- Patients must have recovered from acute toxicity due to prior therapy to Grade 1 or below;
- Signed informed consent.
Who cannot join
- Patients who have previously received topoisomerase I inhibitor therapy;
- Patients with known hypersensitivity to the study drug, its metabolites, or formulation excipients;
- Patients requiring ongoing treatment or prior use of any prohibited medications (e.g., UGT1A1 inhibitors);
- Patients with Gilbert's syndrome;
- Patients with other uncontrolled malignancies concurrently or within 5 years, whose treatment would interfere with the current therapy for recurrent ovarian cancer or affect the prognosis of this treatment. Carcinoma in situ and breast cancer (without active disease or signs of recurrence) are excluded;
- Patients with a history of clinically significant hemorrhage, bowel obstruction, or gastrointestinal perforation within 6 months prior to the start of study treatment, with an estimated life expectancy of less than 3 months;
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- Patients with a history of significant cardiac disease within 6 months, such as uncontrolled hypertension, unstable angina, uncontrolled congestive heart failure (NYHA Class III-IV), or clinically significant arrhythmias requiring antiarrhythmic therapy (except stable atrial fibrillation);
- Patients with known clinically significant active chronic obstructive pulmonary disease (COPD) or other moderate-to-severe chronic respiratory disease within 6 months;
- Patients with known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Patients with treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose, have all neurological symptoms returned to baseline, have no evidence of new or enlarging brain metastases, and are on a daily dose of ≤ 20 mg prednisone or its equivalent. All patients with carcinomatous meningitis are excluded regardless of clinical stability;
- Patients with uncontrolled seizure history or active neurologic disorders; Patients with known HIV-1 or HIV-2 (or HIV-1/2 antibody positive) with detectable viral load, or those taking medications that may interfere with SN-38 metabolism;
- Patients with active HBV or HCV. For patients with a history of HBV or HCV, those with detectable viral load will be excluded;
- Patients with known bleeding diathesis or active bleeding disorders;
- Patients with active ≥ Grade 2 anorexia, nausea, or vomiting, and/or signs of bowel obstruction;
- Patients with other concurrent medical or psychiatric conditions that, in the investigator's opinion, may confound study interpretation or prevent completion of study procedures and follow-up examinations;
- Patients with any unstable medical problems (including the cardiac issues mentioned above, active treatment for symptomatic pulmonary embolism, stroke, renal or hepatic insufficiency, active infection/sepsis requiring intravenous antibiotics);
- Any medical condition that, in the investigator's opinion, poses an undue risk to the patient's participation in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Zhongshan Hospital Fudan University
Shanghai, Shanghai Municipality, 200032
Yulian Chen, 86-21-64041990, emma_serendipity@163.com
About this study
Official title: IMMU-132 in TROP-2 Overexpressed Advanced and Relapsed Ovarian Cancer: A Phases Ib, Single Arm Study
To observe the efficacy and safety of IMMU-132 in patients with advanced or recurrent ovarian cancer with high TROP-2 expression in tumor tissue, who have failed standard therapy or are unable to receive standard treatment.
Read the detailed description
Trophoblast cell surface antigen-2 (TROP-2) is overexpressed in a variety of epithelial-derived tumor tissues and represents a promising antitumor therapeutic target. Novel antibody-drug conjugates (ADCs) targeting TROP-2, such as IMMU-132 (SG), Datopotamab Deruxtecan (Dato-DXd), and Sacituzumab Tirumotecan (MK-2870), are under active development. In ovarian cancer, efficacy data for TROP-2 ADCs mainly derive from pan-solid tumor clinical studies. TROP-2 expression exhibits intratumoral heterogeneity. Currently, there is no standardized or internationally accepted guideline for evaluating TROP-2 expression. TROP-2 expression status can be assessed using the H-score scoring system: 0-100 as low expression, 100-200 as moderate expression, and >200 as high expression. An exploratory analysis of the ASCENT study in triple-negative breast cancer, which categorized TROP-2 expression as high, moderate, or low based on H-score, found that patients with high expression had double the efficacy compared to those with moderate expression (44% vs 22%). Therefore, subsequent studies are warranted to explore effective screening criteria for TROP-2 ADC drugs to achieve more precise diagnosis and treatment. Our center has observed that among 3 patients with heavily pretreated recurrent ovarian cancer and high TROP-2 expression in tumor tissue, 1 achieved a complete response (CR) and 2 achieved partial responses (PR) following SG monotherapy. Safety was favorable, with main side effects being grade 1-2 gastrointestinal reactions and no grade 3-5 adverse reactions. Accordingly, this study will prospectively observe the efficacy of IMMU-132 monotherapy in patients with advanced or recurrent ovarian cancer characterized by high TROP-2 expression in tumor tissue.
- Being tested
- Sacituzumab govitecan monotherapy
- Keywords
- Ovarian cancer, TROP2, Antibody-drug conjugates
- Medical subject headings
- Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sacituzumab govitecan monotherapyDrug
Sacituzumab govitecan monotherapy at a dose of 10 mg/kg administered intravenously on Days 1 and 8 of each 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| TROP2-ADC group | Experimental | IMMU-132 monotherapy at a dose of 10 mg/kg administered intravenously on Days 1 and 8 of each 21-day cycle. Receives: Drug: Sacituzumab govitecan monotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epithelial Ovarian CancerStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Gynecologic Oncology Group
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07674615
- Sponsor's protocol ID
- OC-SG-ADC
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 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 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IMMU-132 in TROP-2 Overexpressed Advanced and Relapsed Ovarian Cancer: A Phases Ib, Single Arm Study
- ClinicalTrials.gov ID
- NCT07674615
- Acronym / sponsor ID
- OC-SG-ADC
- Keywords
- Ovarian cancer, TROP2, Antibody-drug conjugates
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 19 participants (estimated)
- Lead sponsor
- Shanghai Gynecologic Oncology GroupOther government
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 29 Jun 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.
To observe the efficacy and safety of IMMU-132 in patients with advanced or recurrent ovarian cancer with high TROP-2 expression in tumor tissue, who have failed standard therapy or are unable to receive standard treatment.
Detailed description
Trophoblast cell surface antigen-2 (TROP-2) is overexpressed in a variety of epithelial-derived tumor tissues and represents a promising antitumor therapeutic target. Novel antibody-drug conjugates (ADCs) targeting TROP-2, such as IMMU-132 (SG), Datopotamab Deruxtecan (Dato-DXd), and Sacituzumab Tirumotecan (MK-2870), are under active development. In ovarian cancer, efficacy data for TROP-2 ADCs mainly derive from pan-solid tumor clinical studies. TROP-2 expression exhibits intratumoral heterogeneity. Currently, there is no standardized or internationally accepted guideline for evaluating TROP-2 expression. TROP-2 expression status can be assessed using the H-score scoring system: 0-100 as low expression, 100-200 as moderate expression, and >200 as high expression. An exploratory analysis of the ASCENT study in triple-negative breast cancer, which categorized TROP-2 expression as high, moderate, or low based on H-score, found that patients with high expression had double the efficacy compared to those with moderate expression (44% vs 22%). Therefore, subsequent studies are warranted to explore effective screening criteria for TROP-2 ADC drugs to achieve more precise diagnosis and treatment. Our center has observed that among 3 patients with heavily pretreated recurrent ovarian cancer and high TROP-2 expression in tumor tissue, 1 achieved a complete response (CR) and 2 achieved partial responses (PR) following SG monotherapy. Safety was favorable, with main side effects being grade 1-2 gastrointestinal reactions and no grade 3-5 adverse reactions. Accordingly, this study will prospectively observe the efficacy of IMMU-132 monotherapy in patients with advanced or recurrent ovarian cancer characterized by high TROP-2 expression in tumor tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TROP2-ADC group | Experimental | Drug: Sacituzumab govitecan monotherapyIMMU-132 monotherapy at a dose of 10 mg/kg administered intravenously on Days 1 and 8 of each 21-day cycle. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Age ≥ 18 years and ≤ 80 years;
- Histologically confirmed advanced or recurrent high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer;
- Recurrent patients meeting one of the following two conditions:
- Disease recurrence or progression after at least one prior platinum-based chemotherapy regimen, with disease progression occurring less than 6 months from the last dose of platinum-based chemotherapy;
- Disease recurrence or progression after at least three prior platinum-based chemotherapy regimens, with disease progression occurring ≥ 6 months from the last dose of platinum-based chemotherapy, and who are unable to receive standard platinum-based chemotherapy;
Key exclusion criteria (16 listed)
- Patients who have previously received topoisomerase I inhibitor therapy;
- Patients with known hypersensitivity to the study drug, its metabolites, or formulation excipients;
- Patients requiring ongoing treatment or prior use of any prohibited medications (e.g., UGT1A1 inhibitors);
- Patients with Gilbert's syndrome;
- Patients with other uncontrolled malignancies concurrently or within 5 years, whose treatment would interfere with the current therapy for recurrent ovarian cancer or affect the prognosis of this treatment. Carcinoma in situ and breast cancer (without active disease or signs of recurrence) are excluded;
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 govitecan monotherapySacituzumab govitecan monotherapy at a dose of 10 mg/kg administered intravenously on Days 1 and 8 of each 21-day cycle. | Drug | TROP2-ADC group |
Primary outcome
Objective response rate
Time frame: 12 months
The proportion of patients with complete response (CR) and partial response (PR) assessed by the investigator in accordance with the RECIST 1.1 criteria
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 30 Jun 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sacituzumab govitecan monotherapy in people with Epithelial Ovarian Cancer and Fallopian Tube Cancers, run by Shanghai Gynecologic Oncology Group at 1 site in China.
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 16 inclusion and 16 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 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Yulian Chen (86-21-64041990, emma_serendipity@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jun 2026.