Fosrolapitant and Palonosetron for Highly Emetogenic ADC-Induced Nausea and Vomiting in Solid Tumors

NCT07841210 | Active Not Recruiting Phase 2

• 1 other identifier: MA-ANT-II-014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of Fosrolapitant and Palonosetron Hydrochloride for Injection in preventing nausea and vomiting induced by highly emetogenic antibody-drug conjugate (ADC) therapy in patients with solid tumors. A total of 60 patients are planned to be enrolled and divided into two groups: Group A will receive Fosrolapitant and Palonosetron Hydrochloride for Injection plus Dexamethasone plus Olanzapine, and Group B will receive Fosrolapitant and Palonosetron Hydrochloride for Injection plus Dexamethasone.

Conditions

Solid Tumor Cancer

Keywords

Fosrolapitant and Palonosetron Hydrochloride for Injection; ADC; CINV

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects achieving complete response (CR) during Days 0-21 after study drug administration in Cycle 1 (defined as no emetic episodes and no rescue medication use).

  Proportion of subjects achieving complete response (CR) during Days 0-21 after study drug administration in Cycle 1 (defined as no emetic episodes and no rescue medication use). Analysis of the primary study endpoint will be based on the intent-to-treat (ITT) population. The proportion of subjects achieving complete response (CR) during Days 0-21 after initiation of ADC administration in the first treatment cycle will be calculated for both groups. Descriptive between-group analysis of CR rates will be performed using the Cochran-Mantel-Haenszel (CMH) test.

  Day 0-21 after first treatment cycle 1 dosing

Secondary Outcomes (4)

• The proportions of subjects with CR, no significant nausea, no nausea, no vomiting, no rescue medication use, complete protection, and complete control during the period.

  After initiation of antitumor treatment：Acute: 0-24 hour; Delayed: 24-120 hours; Overall: 0-120 hours; Ultra-delayed: 120-168 hours；0 - 168 hours, 120 hours - next treatment and for the 2nd and subsequent treatment cycles 0 - 21 days

• Time to treatment failure

  up to 4 cycles (each cycle is 21 days)

• The proportions of subjects with nausea and vomiting reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0

  up to 4 cycles (each cycle is 21 days)

• The proportions of subjects with Functional Living Index-Emesis (FLIE) assessment.

  up to 4 cycles (each cycle is 21 days)

Other Outcomes (1)

• Incidence of adverse events and serious adverse reactions during treatment.

  The treatment period will be observed for up to 4 cycles (each cycle is 21 days).

Study Arms (2)

Group A：Fosrolapitant and Palonosetron + Dexamethasone + Olanzapine

EXPERIMENTAL

Drug: Fosrolapitant and Palonosetron; Dexamethasone; Olanzapine

Group B：Fosrolapitant and Palonosetron + Dexamethasone

EXPERIMENTAL

Drug: Fosrolapitant and Palonosetron; Dexamethasone

Interventions

Fosrolapitant and Palonosetron; Dexamethasone; Olanzapine DRUG

HR20013 IV on D1; Dexamethasone 12 mg PO QD on D1, 3.75 mg PO BID on D2-4; Olanzapine 5 mg PO on D1-4

Group A：Fosrolapitant and Palonosetron + Dexamethasone + Olanzapine

Fosrolapitant and Palonosetron; Dexamethasone DRUG

HR20013 IV on D1; Dexamethasone 12 mg PO QD on D1, 3.75 mg PO BID on D2-4

Group B：Fosrolapitant and Palonosetron + Dexamethasone

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years, either sex;
• Pathologically confirmed malignant solid tumors;
• Planned to receive initial highly emetogenic ADC therapy on a 3-week regimen;
• Expected survival ≥3 months;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
• Adequate organ function, meeting the following criteria:
• Neutrophil count ≥1.5 × 10⁹/L;
• Hemoglobin ≥90 g/L;
• Platelet count ≥100 × 10⁹/L;
• Total bilirubin ≤1.5 × ULN;
• In patients without known liver metastases, aspartate aminotransferase ≤2.5 × ULN and/or alanine aminotransferase ≤2.5 × ULN (for patients with liver metastases, this may be relaxed to ≤5 × ULN);
• Serum creatinine ≤1.5 × ULN or creatinine clearance ≥50 mL/min;
• ECG: QTc ≤450 ms (male), QTc ≤470 ms (female);
• Echocardiography: left ventricular ejection fraction (LVEF) ≥50%;
• Female subjects of childbearing potential, and male subjects whose partners are women of childbearing potential, must use a highly effective method of contraception from the signing of the informed consent form until 35 days after the last dose; sperm donation is not permitted during the study. Female subjects of childbearing potential must have a negative serum pregnancy test within 72 h before randomization and must be non-lactating. Subjects must clearly understand and voluntarily participate in this study and personally sign the informed consent form.

You may not qualify if:

• Received, within 7 days before randomization, or planned to receive during the treatment period, abdominal radiotherapy (including at or below the diaphragmatic plane), pelvic radiotherapy, whole-body radiotherapy, or whole-brain radiotherapy;
• Planned to receive highly emetogenic chemotherapy from Day 2 after ADC administration until the next treatment;
• Prior use of other ADC drugs;
• Use of medications with potential antiemetic efficacy within 2 days before the start of study treatment: first-generation 5-HT3 receptor antagonists (e.g., ondansetron), phenothiazines (e.g., prochlorperazine), butyrophenones (e.g., haloperidol), benzamides (e.g., metoclopramide), domperidone, cannabinoids, traditional Chinese medicines with potential antiemetic effects, scopolamine, cyclizine, etc.;
• Initiation of benzodiazepines or opioids within 2 days before the start of study treatment (except triazolam, temazepam, or midazolam administered alone daily);
• Initiation of morphine within 7 days before the start of study treatment (except those receiving a stable dose);
• Receipt of systemic corticosteroid therapy (including but not limited to dexamethasone, hydrocortisone, methylprednisolone, or prednisolone) or sedating antihistamines (e.g., diphenhydramine) within 7 days before the start of study treatment (Note: single-dose steroids for prevention of contrast allergy and topical or inhaled administration are permitted);
• Use of palonosetron within 14 days before the start of study treatment;
• Use of NK-1 receptor antagonists within 28 days before the start of study treatment;
• Use of specific CYP3A4 substrates (terfenadine, cisapride, astemizole) or CYP3A4 inhibitors (e.g., ritonavir, clarithromycin, ketoconazole or itraconazole, diltiazem, etc.) within 7 days before the start of study treatment, or use of strong CYP3A4 inducers (e.g., phenobarbital, rifampin, phenytoin, carbamazepine, etc.) or specific CYP2D6 substrates (thioridazine, pimozide) within 28 days before randomization;
• Vomiting and/or retching, or nausea, within 24 h before the start of study treatment;
• Symptomatic brain metastases or any symptoms suggestive of brain metastases or intracranial hypertension;
• Inadequately controlled serous cavity effusion, including pleural effusion, ascites, and pericardial effusion (those controlled after treatment and stable for ≥2 weeks may be enrolled);
• Severe cardiovascular disease within 3 months before the start of study treatment, including but not limited to acute myocardial infarction, unstable angina, significant valvular or pericardial disease, history of ventricular tachycardia, symptomatic chronic heart failure (New York Heart Association \[NYHA\] class II-IV), or history of serious cardiac conduction abnormalities (e.g., torsades de pointes);
• Poorly controlled hypertension before the start of study treatment (two consecutive resting systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg);

Sponsors & Collaborators

• Nanyang Central Hospital: collaborator
• Hubei Cancer Hospital: collaborator
• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Location

MeSH Terms

Interventions

Palonosetron; Dexamethasone; Olanzapine

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzodiazepines; Benzazepines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2026
• First Posted: September 25, 2026
• Study Start: September 14, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2028
• Last Updated: September 25, 2026

Record last verified: 2026-09

Locations

CN (1)