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Monoclonal Antibodies

Sacituzumab Govitecan-hziy for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Gilead Sciences

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 (predose) and day 22

Awards & highlights

Study Summary

This trial is testing a new cancer drug, sacituzumab govitecan-hziy, in people with solid tumors and moderate liver impairment. The goal is to find the safe starting dose and evaluate how well the drug works and is tolerated.

Eligible Conditions

Advanced or Metastatic Solid Tumors
Liver Failure

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 (predose) and day 22

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 (predose) and day 22

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 (predose) and day 22 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

PK Parameter: AUC_0-168 of Free SN-38, SN-38 Glucuronide, Total SN-38, and Sacituzumab Govitecan-hziy

PK Parameter: AUC_last of Free SN-38, SN-38 Glucuronide, Total SN-38, and Sacituzumab Govitecan-hziy

PK Parameter: Cmax of Free SN-38, SN-38 Glucuronide, Total SN-38, and Sacituzumab Govitecan-hziy

+3 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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Advanced or Metastatic Solid Tumor and Normal Liver functionExperimental Treatment1 Intervention

Participants with advanced or metastatic solid tumor and normal hepatic function will receive sacituzumab govitecan-hziy 10 mg/kg on Days 1 and 8. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).

Group II: Advanced or Metastatic Solid Tumor and Moderate Liver ImpairmentExperimental Treatment1 Intervention

Participants with advanced solid tumor and moderate hepatic impairment will receive an escalating dose of sacituzumab govitecan-hziy on Days 1 and 8. The dose-escalation plan will start at 5 mg/kg and escalate to 7.5 mg/kg, and finally 10 mg/kg, if deemed to be safe. At the completion of study treatment, participants who are deriving benefit from sacituzumab govitecan-hziy may continue to receive treatment in a Gilead sponsored rollover study (IMMU-132-14; NCT04319198).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sacituzumab Govitecan-hziy

2019

Completed Phase 3

~550

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Gilead SciencesLead Sponsor

1,084 Previous Clinical Trials

848,232 Total Patients Enrolled

Gilead Study DirectorStudy DirectorGilead Sciences

343 Previous Clinical Trials

186,663 Total Patients Enrolled

Media Library

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04617522 — Phase 1

Solid Tumors Research Study Groups: Advanced or Metastatic Solid Tumor and Moderate Liver Impairment, Advanced or Metastatic Solid Tumor and Normal Liver function

Solid Tumors Clinical Trial 2023: Sacituzumab Govitecan-hziy Highlights & Side Effects. Trial Name: NCT04617522 — Phase 1

Sacituzumab Govitecan-hziy (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04617522 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Sacituzumab Govitecan-hziy been tested in other clinical experiments?

"Sacituzumab Govitecan-hziy was initially trialed in 2018 at Comprehensive Cancer Centers of Nevada (CCCN) - Central Valley, with two trials having been completed. At present, there are 33 ongoing studies being conducted across the United States; many of these have research hubs located in Houston and Delaware."

Answered by AI

What is the cap on the number of people participating in this trial?

"Affirmative. Clinicaltrials.gov records suggest that this medical trial, first posted in April 6th 2021 is still enrolling participants. 30 individuals are needed to be recruited from 5 different clinics for the study's completion."

Answered by AI

Is there still opportunity for enrollment in this research program?

"The information posted on clinicaltrials.gov suggests that this trial is currently recruiting participants, with the initial posting having been made in April 2021 and the most recent revision being done in November of 2022."

Answered by AI

Has Sacituzumab Govitecan-hziy been given the official seal of approval from the FDA?

"Since Sacituzumab Govitecan-hziy is in the early stages of clinical trials, there is limited evidence to support its safety and efficacy. Thus, it was given a score of 1 out of 3."

Answered by AI

What medical conditions has Sacituzumab Govitecan-hziy been approved to address?

"Sacituzumab Govitecan-hziy is used for therapeutic procedure and can be applied to a variety of illnesses such as pharmacotherapy, uc 84572, and breast cancer."

Answered by AI

How many medical centers are overseeing the clinical trial?

"There are currently 5 sites conducting this trial, located in Houston, Newark and Austin as well as other nearby cities. It would be beneficial to opt for the nearest vicinity to reduce travelling demands if you decide to participate."

Answered by AI

Is this an inaugural examination of its kind?

"As of now, 33 Sacituzumab Govitecan-hziy trials are live in 418 cities and 32 countries. These began with a Phase 1 & 2 trial sponsored by Hoffmann-La Roche which included 435 participants back in 2018; since then, two more studies have been conducted."

Answered by AI

Recent research and studies

Clinical Cancer ResearchJournal

Humanized Anti-trop-2 Igg-sn-38 Conjugate for Effective Treatment of Diverse Epithelial Cancers: Preclinical Studies in Human Cancer Xenograft Models and Monkeys

Cardillo, Thomas M., Serengulam V. Govindan, Robert M. Sharkey, Preeti Trisal, and David M. Goldenberg. 2011. “Humanized Anti-trop-2 Igg-sn-38 Conjugate for Effective Treatment of Diverse Epithelial Cancers: Preclinical Studies in Human Cancer Xenograft Models and Monkeys”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-10-2939.

brca1/2Journal

Synthetic Lethality Exploitation by an Anti–trop-2-sn-38 Antibody–drug Conjugate, IMMU-132, Plus PARP Inhibitors in <i>brca1/2</i>–wild-type Triple-negative Breast Cancer

Cardillo, Thomas M., Robert M. Sharkey, Diane L. Rossi, Roberto Arrojo, Ali A. Mostafa, and David M. Goldenberg. 2017. “Synthetic Lethality Exploitation by an Anti–trop-2-sn-38 Antibody–drug Conjugate, IMMU-132, Plus PARP Inhibitors in brca1/2–wild-type Triple-negative Breast Cancer”. Clinical Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1078-0432.ccr-16-2401.

NephronJournal

Prediction of Creatinine Clearance from Serum Creatinine

Cockcroft, Donald W., and Henry Gault. 1976. “Prediction of Creatinine Clearance from Serum Creatinine”. Nephron. S. Karger AG. doi:10.1159/000180580.

OncotargetJournal