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Monoclonal Antibodies

Sacituzumab Govitecan for Endometrial Cancer

Phase 2

Recruiting

Led By Alessandro D. Santin, M.D.

Research Sponsored by Alessandro Santin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have adequate hepatic function: Bilirubin ≤ 1.5 X laboratory normal. SGOT/SGPT ≤ 3 X laboratory normal or ≤ 5 X laboratory normal if known liver metastases.

Patients with measurable recurrent disease of any previous substage (I-IV) are eligible to enrollment.

Must not have

Have a known history of HIV-1/2 with uncontrolled viral load and on medications that may interfere with SN-38 metabolism.

Patients with a history of an anaphylactic reaction to irinotecan or ≥ Grade 3 GI toxicity to prior irinotecan.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug for endometrial cancer that has come back or does not respond to other treatments.

Who is the study for?

This trial is for adults with persistent or recurrent endometrial carcinoma that worsened after platinum-based chemotherapy. They must have measurable disease, adequate organ function, and an ECOG performance status of 0 or 1. Participants need to be at least two weeks past prior treatments and recovered from acute toxicities. Pregnant women are excluded, as well as those with active second cancers, significant heart conditions, unstable medical issues, CNS metastases, certain viral infections, bleeding disorders or a history of severe reactions to similar drugs.

What is being tested?

The study tests Sacituzumab Govitecan (IMMU-132) in patients with endometrial cancer that has returned or persisted despite previous treatment. It's a Phase 2 trial where all participants receive the drug without being randomly assigned to different groups.

What are the potential side effects?

Potential side effects include allergic reactions related to irinotecan (a component of IMMU-132), gastrointestinal issues like nausea and diarrhea, risk of bleeding or intestinal obstruction due to the drug's mechanism which affects DNA replication in cancer cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My liver functions are within the required range.

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My cancer has come back and can be measured.

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A specialist confirmed my diagnosis through tissue examination.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I have at least one tumor that can be measured by scans or physical exam.

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My blood tests show my bone marrow is functioning well.

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My kidney function is good, with creatinine ≤ 2.0 mg/dL.

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My endometrial cancer has worsened after platinum chemotherapy or didn't respond to it.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have HIV with a high viral load and take medication that could affect my treatment.

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I have had a severe allergic reaction or major stomach issues from irinotecan.

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I have been treated with topoisomerase I inhibitors before.

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I have a bleeding disorder or am currently experiencing active bleeding.

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I do not have serious heart problems like uncontrolled high blood pressure or heart failure.

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I do not have an active hepatitis B or C infection.

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I have an uncontrolled seizure disorder or active neurological disease.

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I have severe appetite loss, nausea, vomiting, diarrhea, or signs of a blocked intestine.

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I do not have any unstable health issues like heart problems, blood clots, stroke, kidney or liver problems, or infections needing IV antibiotics.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Assess the safety profile of sacituzumab govitecan in endometrial cancer patients (adverse events as assessed by CTCAE v5.0)

Durable disease control rate (DDCR)

Duration of overall survival (OS)

+1 more

Side effects data

From 2020 Phase 3 trial • 529 Patients • NCT02574455

40%

Fatigue

30%

Nausea

27%

Anaemia

25%

Neutropenia

23%

Constipation

21%

Decreased appetite

20%

Neutrophil count decreased

18%

Cough

18%

Dyspnoea

17%

Diarrhoea

16%

Alopecia

16%

Vomiting

13%

Hypokalaemia

13%

Headache

13%

Back pain

13%

Asthenia

12%

Pyrexia

12%

Aspartate aminotransferase increased

11%

Oedema peripheral

11%

Neuropathy peripheral

10%

Alanine aminotransferase increased

10%

White blood cell count decreased

Urinary tract infection

Myalgia

Pain in extremity

Platelet count decreased

Arthralgia

Dizziness

Abdominal pain

Weight decreased

Mucosal inflammation

Lymphocyte count decreased

Bone pain

Hypomagnesaemia

Hypertension

Thrombocytopenia

Stomatitis

Insomnia

Pain

Rash

Blood alkaline phosphatase increased

Hyperglycaemia

Oropharyngeal pain

Hypophosphataemia

Anxiety

Abdominal pain upper

Breast pain

Upper respiratory tract infection

Musculoskeletal chest pain

Dysgeusia

Lymphoedema

Pruritus

Pleural effusion

Gastrooesophageal reflux disease

Chills

Nasopharyngitis

Hypocalcaemia

Febrile neutropenia

Sepsis

Pneumonia

Nasal congestion

Dyspnoea exertional

Dry skin

Rash maculo-papular

Pericardial effusion

Pulmonary embolism

Respiratory failure

Cellulitis

100%

80%

60%

40%

20%

Study treatment Arm

Treatment of Physician's Choice (TPC)

Sacituzumab Govitecan

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Sacituzumab GovitecanExperimental Treatment1 Intervention

Sacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan

2019

Completed Early Phase 1

~30

0 / 18Eligibility criteria met