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

NCT07692451 | Not Yet Recruiting Phase 2

• 1 other identifier: HR20013-II-001
• Study Type: interventional
• Target: 124
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)

Outcome Measures

Primary Outcomes (1)

• Complete response rate

  Within 14 days after ADC administration

Study Arms (2)

Fosrolapitant and Palonosetron + dexamethasone + placebo

EXPERIMENTAL

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Drug: Fosrolapitant and Palonosetron for injection

fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone

ACTIVE COMPARATOR

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Drug: Fosrolapitant and Palonosetron for injection

Interventions

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

Fosrolapitant and Palonosetron + dexamethasone + placebo; fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Nausea

Interventions

Palonosetron; Injections

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

li huiping chief physician

CONTACT

+86-13811012595; huipingli2012@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Drug: Fosrolapitant and Palonosetron；dexamethasone Drug: fosaprepitant dimeglumine for injection；palonosetron

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 9, 2026

Record last verified: 2026-06