Solid Tumor CancerPhase 2NCT07841210

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

A Phase 2 study testing Fosrolapitant and Palonosetron; Dexamethasone; Olanzapine and Fosrolapitant and Palonosetron; Dexamethasone in people with Solid Tumor Cancer, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Solid Tumor Cancer
What is being tested?: Fosrolapitant and Palonosetron; Dexamethasone; Olanzapine and Fosrolapitant and Palonosetron; Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteChina
Study dates: 14 Sep 2026to 31 Jan 2028
Phase: Phase 2
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:

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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.

Who cannot join

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);

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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);
Active hepatitis B (HBV DNA ≥2000 IU/mL or 10⁴ copies/mL), active hepatitis C (HCV-Ab positive and HCV-RNA ≥ upper limit of normal), acquired immunodeficiency syndrome (AIDS) or HIV-positive, or syphilis-positive;
Concomitant disease that precludes dexamethasone administration, such as active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction, etc.);
Known contraindications to NK-1 receptor antagonists, 5-HT3 receptor antagonists, or dexamethasone;
Participation in another clinical trial within 30 days before the start of study treatment (based on use of study drug);
Other circumstances considered by the investigator to make participation in this study inappropriate.

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

Official title: An Exploratory Study of Fosrolapitant and Palonosetron Hyerocthoride for the Prevention of Nausea and Vomiting Induced by Highly Emetogenic ADC Therapy in Patients With Solid Tumors

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.

Read the detailed description

Antibody-drug conjugates (ADCs) have brought hope to cancer patients. For ADCs, nausea and vomiting are common adverse reactions. Compared with traditional chemotherapy, ADC-induced nausea and vomiting are usually more complex, with a higher risk of delayed nausea and vomiting. For example, trastuzumab deruxtecan, a HER2-targeted ADC, has a median time to onset of vomiting of 9.5 days and a median duration of 3 days, and a median time to onset of nausea of 3 days and a median duration of up to 10 days. Sacituzumab govitecan, a Trop-2-targeted ADC, has a median time to onset of vomiting of 24.5 days and a median duration of 1.5 days, and a median time to onset of nausea of 8 days and a median duration of 5.5 days. Fosrolapitant and Palonosetron Hydrochloride for Injection, an innovative fixed-dose combination antiemetic, was approved for marketing by the Center for Drug Evaluation (CDE) on May 27, 2025. The half-life of fosrolapitant in Fosrolapitant and Palonosetron Hydrochloride for Injection is as long as 188 h, which can cover the acute, delayed, and ultra-delayed phases (120-168 h) of anti-tumor treatment-induced nausea and vomiting. This study intends to use Fosrolapitant and Palonosetron Hydrochloride for Injection as the basis combined with dexamethasone ± olanzapine to explore its efficacy and safety in preventing nausea and vomiting caused by highly emetogenic ADCs, and also to observe the preventive effect of other standard treatment (fosaprepitant + palonosetron + dexamethasone) on nausea and vomiting caused by highly emetogenic ADCs. It also aims to identify signals for the optimal management model of highly emetogenic ADC-related nausea and vomiting, so as to better guide clinical practice.

Conditions: Solid Tumor Cancer
Being tested: Fosrolapitant and Palonosetron; Dexamethasone; Olanzapine, Fosrolapitant and Palonosetron; Dexamethasone
Keywords: Fosrolapitant and Palonosetron Hydrochloride for Injection, ADC, CINV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Fosrolapitant and Palonosetron; Dexamethasone; OlanzapineDrug
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
Fosrolapitant and Palonosetron; DexamethasoneDrug
HR20013 IV on D1; Dexamethasone 12 mg PO QD on D1, 3.75 mg PO BID on D2-4

Study groups in NCT07841210
Study group	Role	What they receive
Group A：Fosrolapitant and Palonosetron + Dexamethasone + Olanzapine	Experimental	Not described Receives: Drug: Fosrolapitant and Palonosetron; Dexamethasone; Olanzapine
Group B：Fosrolapitant and Palonosetron + Dexamethasone	Experimental	Not described Receives: Drug: Fosrolapitant and Palonosetron; Dexamethasone

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
The proportions of subjects with complete response (CR), no significant nausea, no nausea, no vomiting, no rescue medication use, complete protection, and complete control during the acute phase (0-24 h after initiation of antitumor treatment), delayed phase (24-120 h after initiation of antitumor treatment), overall phase (0-120 h after initiation of antitumor treatment), super-delayed phase (120-168 h after initiation of antitumor treatment), 0-168 h, 120 h to the next treatment, and Days 0-21 in each treatment cycle.
Measured: 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
Time to treatment failure in each cycle.
Measured: 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
Patient-reported outcomes (PROs): nausea and vomiting reported according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 6.0;
Measured: up to 4 cycles (each cycle is 21 days)
The proportions of subjects with Functional Living Index-Emesis (FLIE) assessment.
Functional Living Index-Emesis (FLIE) assessment.
Measured: up to 4 cycles (each cycle is 21 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Sep 202631 Jan 2028

First posted25 Sep 2026
Study start14 Sep 2026
Primary completion31 Jan 2028 (estimated)
Study completion31 Jan 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Solid Tumor CancerStudies of the same condition, open and under way.
More trials run by Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07841210
Sponsor's protocol ID: MA-ANT-II-014
Status last verified: Sep 2026
First submitted: 14 Sep 2026
Last updated: 25 Sep 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

All Solid Tumor Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Exploratory Study of Fosrolapitant and Palonosetron Hyerocthoride for the Prevention of Nausea and Vomiting Induced by Highly Emetogenic ADC Therapy in Patients With Solid Tumors
ClinicalTrials.gov ID: NCT07841210
Acronym / sponsor ID: MA-ANT-II-014
Conditions: Solid Tumor Cancer
Keywords: Fosrolapitant and Palonosetron Hydrochloride for Injection, ADC, CINV
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 60 participants (actual)
Lead sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyUniversity, hospital or other
Collaborators: Nanyang Central Hospital, Hubei Cancer Hospital
Study start: 14 Sep 2026 (actual)
Primary completion: 31 Jan 2028 (estimated)
Study completion: 31 Jan 2028 (estimated)
First posted: 25 Sep 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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;

Key exclusion criteria (20 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fosrolapitant and Palonosetron; Dexamethasone; OlanzapineHR20013 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	Drug	Group A：Fosrolapitant and Palonosetron + Dexamethasone + Olanzapine
Fosrolapitant and Palonosetron; DexamethasoneHR20013 IV on D1; Dexamethasone 12 mg PO QD on D1, 3.75 mg PO BID on D2-4	Drug	Group B：Fosrolapitant and Palonosetron + Dexamethasone

Primary outcome

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).
Time frame: Day 0-21 after first treatment cycle 1 dosing
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.

4 secondary outcomes

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.
Time frame: 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
Time frame: 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
Time frame: up to 4 cycles (each cycle is 21 days)
The proportions of subjects with Functional Living Index-Emesis (FLIE) assessment.
Time frame: up to 4 cycles (each cycle is 21 days)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.

Related trials for Solid Tumor Cancer

RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). (time frame: Day 0-21 after first treatment cycle 1 dosing). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07841210.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.