Rollover Study in Participants With Metastatic Solid Tumors Benefiting From Therapy With Sacituzumab Govitecan-hziy

Gilead Sciences

Status and phase: Completed; Phase 4

Conditions: Metastatic Solid Tumors

Treatments: Drug: Sacituzumab Govitecan-hiy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04319198

IMMU-132-14

2023-505336-34 (Other Identifier)

Details and patient eligibility

About

The goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (SG), and how safe it is in participants with metastatic cancer (cancer that has spread).

Full description

This is a rollover study. Only participants who continue to receive clinical benefit from continuation of SG therapy and are tolerating therapy at the time of enrollment are eligible for this study. Participants enrolled may continue to receive SG at the dose that they were receiving in the Gilead parent study at the time of consenting to participate in this rollover study.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Receiving ongoing treatment with sacituzumab govitecan in a Gilead (previously Immunomedics)-sponsored parent study.
• Continuing to receive clinical benefit from sacituzumab govitecan-hziy therapy.

Key Exclusion Criteria:

• Females who are pregnant or lactating.
• Initiated therapy with another cancer therapeutic agent since receiving last dose of study drug on the parent study in which they participated.
• Experienced a toxicity from sacituzumab govitecan-hziy that resulted in permanent discontinuation of therapy.
• Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-01)

Experimental group

Description:

All participants who previously received SG in the parent study (IMMU-132-01) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until progressive disease (PD), toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

Treatment:

Drug: Sacituzumab Govitecan-hiy

Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-05)

Experimental group

Description:

All participants who previously received SG in the parent study (IMMU-132-05) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

Treatment:

Drug: Sacituzumab Govitecan-hiy

Sacituzumab Govitecan-hziy (Parent Study: IMMU-132-15)

Experimental group

Description:

All participants who previously received SG in the parent study (IMMU-132-15) will continue to receive the same dose of SG up to a maximum of 10 mg/kg, on Days 1 and 8 of 21-day cycle until PD, toxicity, withdrawal of consent, lost to follow-up or loss of clinical benefit, or sponsor termination of the study was documented and were followed for long-term safety up to maximum 3.9 years.

Treatment:

Drug: Sacituzumab Govitecan-hiy