Fosrolapitant and Palonosetron for the Prevention of Antibody-drug Conjugate-induced Nausea and Vomiting

This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting

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Key information

Conditions

Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs) Nausea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Exclusion criteria

18 years of age or older, of either gender
Has a diagnosed malignant tumor
has never been treated with ADCs and is to receive the first course of ADCs
Predicted life expectancy of ≥ 3 months
Has a performance status (ECOG scale) of 0 to 1
Adequate bone marrow, kidney, and liver function
Women of childbearing potential must have negative pregnancy test (serum test) results within 72 hours prior to enrollment
Able and willing to provide a written informed consent

Treatment and study plan

Fosrolapitant and Palonosetron for injection

Drug

Experimental: Drug：Fosrolapitant and Palonosetron for injection Drug：Dexamethasone Drug: placebo

Active Comparator: Drug：HR20013 placebo Drug: fosaprepitant dimeglumine for injection Drug：Palonosetron injection Drug: Dexamethasone

Primary outcomes

Complete response rate

Time frame: Within 14 days after ADC administration

Study contacts

Contact information is provided by the study sponsor or research team.

li huiping chief physician

CONTACT

[email protected]

+86-13811012595

Sponsors and collaborators

Lead sponsor

Peking University Cancer Hospital & Institute

Other

Registry information

Official study title

A Randomized Controlled Study of Fosrolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugates in Cancer Patients

Important dates

Study start: 2026
Primary completion: 2027
Study completion: 2027
First posted: Jul 9, 2026
Registry last updated: Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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