Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)Phase 2NCT07692451
Fosrolapitant and Palonosetron for the Prevention of Antibody-drug Conjugate-induced Nausea and Vomiting
A Phase 2 study testing Fosrolapitant and Palonosetron for injection in people with Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs), run by Peking University Cancer Hospital & Institute.
Trial summary
This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)
- What is being tested?
- Fosrolapitant and Palonosetron for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Sep 2027
- 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
- -
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized Controlled Study of Fosrolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugates in Cancer Patients
This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting
- Being tested
- Fosrolapitant and Palonosetron for injection
- Medical subject headings
- Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosrolapitant and Palonosetron for injectionDrug
- 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
| Study group | Role | What they receive |
|---|---|---|
| Fosrolapitant and Palonosetron + dexamethasone + placebo | Experimental | Use this field to provide additional information about the arm, including a description of the intervention(s) administered. Receives: Drug: Fosrolapitant and Palonosetron for injection |
| fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone | Active comparator | Use this field to provide additional information about the arm, including a description of the intervention(s) administered. Receives: Drug: Fosrolapitant and Palonosetron for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete response rate
Measured: Within 14 days after ADC administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Jul 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs)Studies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- Model description
- Drug: Fosrolapitant and Palonosetron；dexamethasone Drug: fosaprepitant dimeglumine for injection；palonosetron
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692451
- Sponsor's protocol ID
- HR20013-II-001
- Status last verified
- Jun 2026
- First submitted
- 3 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study of Fosrolapitant and Palonosetron for the Prevention of Nausea and Vomiting Induced by Antibody-Drug Conjugates in Cancer Patients
- ClinicalTrials.gov ID
- NCT07692451
- Acronym / sponsor ID
- HR20013-II-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Jul 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Jul 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.
This study is aimed to evaluate the efficacy and safety of Fosrolapitant and Palonosetron for Antibody-drug conjugate-induced nausea and vomiting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Drug: Fosrolapitant and Palonosetron；dexamethasone Drug: fosaprepitant dimeglumine for injection；palonosetron
| Arm | Type | Receives |
|---|---|---|
| Fosrolapitant and Palonosetron + dexamethasone + placebo | Experimental | Drug: Fosrolapitant and Palonosetron for injectionUse this field to provide additional information about the arm, including a description of the intervention(s) administered. |
| fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone | Active comparator | Drug: Fosrolapitant and Palonosetron for injectionUse this field to provide additional information about the arm, including a description of the intervention(s) administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (8 listed)
- 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
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 for injection• 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 | Drug | Fosrolapitant and Palonosetron + dexamethasone + placebo, fosaprepitant dimeglumine for injection+palonosetron hydrochloride injection+dexamethasone |
Primary outcome
Complete response rate
Time frame: Within 14 days after ADC administration
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 9 Jul 2026.
- Individual participant dataSharing planned: Undecided
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fosrolapitant and Palonosetron for injection in people with Nausea and Vomiting Induced by Antibody-drug Conjugates (ADCs), run by Peking University Cancer Hospital & Institute.
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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact li huiping chief physician (+86-13811012595, huipingli2012@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete response rate (time frame: Within 14 days after ADC administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.