Fosrolapitant Combined With Palonosetron to Prevent Trastuzumab Rezetecan Related CINV

A Multicenter, Exploratory Clinical Study of the Efficacy and Safety of Phentolamine and Palonosetron for the Prevention of Nausea and Vomiting Associated With Recom-Trastuzumab Therapy

This study is a prospective, single-arm, multicenter, exploratory clinical trial divided into a screening phase, a treatment phase, and a follow-up phase. The study aims to evaluate the efficacy and safety of foslorapitant palonosetron for injection in preventing nausea and vomiting caused by treatment with recanituzumab. All patients who meet the inclusion criteria and do not meet any exclusion criteria are eligible for enrollment in this study and are scheduled to receive targeted therapy, antiemetic treatment, and follow-up.

Dosage Regimen Eligible subjects will receive a prophylactic antiemetic regimen consisting of foslorapitant and palonosetron.

The dosage regimen is as follows:

Day 1 (D1): Foslorapitant and palonosetron (218 mg foslorapitant and 0.25 mg palonosetron hydrochloride), administered intravenously (IV) 1 hour prior to chemotherapy.

Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.

Study Overview

• Status: Recruiting
• Conditions: Chemotherapy-Induced Nausea and Vomiting (CINV)
• Intervention / Treatment: Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection

• Study Type: Interventional
• Enrollment (Estimated): 56
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Zhansheng Jiang Tianjin Cancer Hospital Airport Hospital; Phone Number: 022-23340123; Email: zhjiang@tmu.edu.cn

Study Locations

• China
  • Tianjin, China
    • Recruiting
    • Tianjin Cancer Hospital Airport Hospital
    • Contact: Zhansheng Jiang Tianjin Cancer Hospital Airport Hospital; Phone Number: 022-23340123; Email: zhjiang@tmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Sign a written informed consent form and voluntarily enroll in this study;
2. Be at least 18 years of age; gender is not a restriction;
3. Be a patient scheduled to receive treatment with Trastuzumab Rezetecan;
4. Have an ECOG performance status score of 0-2;
5. No ascites or pleural effusion requiring drainage;
6. No gastrointestinal obstruction, such as pyloric stenosis or intestinal obstruction;
7. Expected survival of ≥12 weeks;

8. Good organ and bone marrow function, defined as follows:

   Hematologic System (No blood transfusions or treatment with hematopoietic growth factors within the past 14 days)

   • Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹/L
   • Platelets (PLT) ≥ 100×10⁹/L
   • Hemoglobin (Hb) ≥ 90 g/L Liver Function
   • Total Bilirubin (TBIL) ≤ 1.5×ULN (For patients with Gilbert's syndrome: ≤ 3×ULN)
   • Alanine Aminotransferase (ALT) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)
   • Aspartate Aminotransferase (AST) ≤ 2.5×ULN (Patients with liver metastases: ≤ 5×ULN)
   • Albumin (ALB) ≥ 30 g/L Renal Function
   • Creatinine (Cr) ≤ 1.5×ULN
   • Creatinine Clearance (Ccr)
   • (Calculated only when creatinine > 1.5×ULN) Endogenous creatinine clearance ≥ 50 mL/min (Cockcroft-Gault formula) Cardiac Function
   • 12-lead electrocardiogram No severe arrhythmias, and a mean Fridericia-corrected QT interval (QTc) of <450 ms (males) or <470 ms (females)
   • Echocardiogram Left ventricular ejection fraction (LVEF) ≥ 50%
9. Agree to cooperate in completing daily nausea and vomiting logs and scale assessments;
10. Understand the nature of this study; the patient and/or legal guardian voluntarily agree to participate in this trial and sign the informed consent form.

Exclusion Criteria:

1. Allergy to the study drug or its excipients;
2. Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
3. Nausea or vomiting at the time of enrollment requiring treatment with antiemetics;
4. Use of medications with antiemetic effects within 2 days prior to the first dose;
5. Initiation of potent opioid analgesics within 48 hours prior to enrollment (adjustment of the dose of medications already in use is permitted);
6. Presence of conditions affecting the assessment of vomiting, such as gastrointestinal obstruction, gastroparesis, or intestinal obstruction;
7. Patients who are difficult to enroll due to clinically diagnosed psychiatric disorders;
8. Localized or active systemic infections requiring treatment;
9. Pregnant or breastfeeding women, as well as patients of childbearing age who refuse to use appropriate contraceptive measures during the course of this trial;
10. Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug (patients who failed screening for other clinical trials may be enrolled in this study);
11. Patients with other factors deemed by the investigator to be unsuitable for participation in this study, such as any physiological or psychological conditions that may increase study risks, affect patient adherence to the protocol, or interfere with the patient's ability to complete the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Antiemetic Prophylaxis; All subjects who meet the inclusion criteria will receive prophylactic antiemetic treatment with Fosrolapitant and Palonosetron Hydrochloride to receiving an infusion of Trastuzumab Rezetecan. During follow-up, investigators will collect data on nausea, vomiting, use of rescue medication, and adverse events to evaluate the efficacy and safety of this hormone-free antiemetic regimen.

Drug: Fosrolapitant and Palonosetron Hydrochloride for Injection; D1: Fosrolapitant and Palonosetron Hydrochloride for Injection (218 mg of pholorapitant and 0.25 mg of palonosetron hydrochloride), IV, administered 1 hour before chemotherapy. Observe for two treatment cycles (C1-C2); Starting from the first dose, record the patient's daily vomiting frequency, severity of nausea, and medication adherence.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Complete Response (CR) Rate	The proportion of participants without any vomiting episodes and without receiving rescue antiemetic medication during the overall 0-120 hour period after trastuzumab rezetecan infusion.	0 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Response (CR) Rate in Acute Phase (0-24 h)	Percentage of participants with no vomiting and no rescue antiemetics within 0-24 hours post trastuzumab rezetecan	0 to 24 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Delayed Phase (24-120 h)	Percentage of participants with no vomiting and no rescue antiemetics within 24-120 hours post trastuzumab rezetecan	24 to 120 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Response (CR) Rate in Very Delayed Phase (120-168 h)	Percentage of participants with no vomiting and no rescue antiemetics within 120-168 hours post trastuzumab rezetecan	120 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Protection (CP) Rate	Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score <25 mm during observation period	0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Complete Control (TC) Rate	Proportion of participants without vomiting, no rescue medication, and maximum VAS nausea score <5 mm during observation period	0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
No Nausea Rate & No Vomiting Rate & No Rescue Medication Rate	No nausea rate: participants with maximum VAS nausea score <5 mm; No vomiting rate: participants with zero vomiting episodes (rescue use allowed); No rescue medication rate: participants who never use rescue antiemetics	0 to 168 hours after trastuzumab rezetecan infusion within Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Rate of Trastuzumab Rezetecan Dose Delay or Reduction Due to Nausea and Vomiting	Percentage of subjects whose trastuzumab rezetecan dose is delayed or reduced caused by treatment-induced nausea and vomiting	ntire duration of Cycle 1 and Cycle 2 (each treatment cycle is 21 days)
Safety Endpoints (Adverse Events, Serious Adverse Events)	Incidence, severity (graded per CTCAE v5.0) and relatedness of all adverse events (AEs), treatment-related AEs, ≥3 grade AEs and serious adverse events (SAEs); changes in vital signs and laboratory parameters	From informed consent signing to 30 days after last study drug administration

Collaborators and Investigators

• Sponsor: Tianjin Medical University Cancer Institute and Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: July 20, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 24, 2026

Study Record Updates

• Last Update Posted (Actual): July 24, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Vomiting; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Drug Administration Routes; Drug Therapy; Heterocyclic Compounds, Bridged-Ring; Isoquinolines; Quinuclidines; Palonosetron; Injections
• Other Study ID Numbers: CINV-2026-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No