Cancer of Unknown PrimaryPhase 2NCT06869174
Pucotenlimab Combined with MRG002 for HER2-positive Cancer of Unknown Primary
A Phase 2 study testing Pucotenlimab combined with MRG002 in people with Cancer of Unknown Primary, run by Zhiguo Luo, MD, PhD at 1 site in China.
Trial summary
This study is a single-arm, open-label, multicenter Phase II clinical trial designed to observe and evaluate the efficacy and safety of Pucotenlimab in combination with MRG002 in patients with HER2-positive (IHC 2+ or 3+) cancer of unknown primary. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer of Unknown Primary
- What is being tested?
- Pucotenlimab combined with MRG002
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 8 Mar 2025to 8 Aug 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
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Subjects must be ≥18 years of age on the day of signing the informed consent form, with no gender restrictions.
- Expected survival of ≥3 months.
- Subjects with histologically confirmed squamous cell carcinoma, adenocarcinoma, or undifferentiated carcinoma of unknown primary origin by pathology laboratory, and who also meet the criteria of HER2 immunohistochemistry (IHC) 2+ or 3+. Subjects must have received at least one line of systemic therapy, including but not limited to targeted therapy, immunotherapy, chemotherapy, etc.
- Subjects must be able to provide a tumor specimen for pathological testing (paraffin block, paraffin-embedded sections, or fresh tissue sections are acceptable).
- Radiological evidence of disease progression during or after the most recent treatment, as confirmed by the investigator; according to RECIST 1.1 criteria, at least one measurable lesion at baseline.
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- Adverse events (AEs) related to prior anti-tumor therapy must have resolved to ≤Grade 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0), with the exception of alopecia, non-clinically significant or asymptomatic laboratory abnormalities.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days prior to dosing.
- No severe cardiac dysfunction, with a left ventricular ejection fraction (LVEF) ≥50% within 28 days prior to dosing.
- Adequate organ function.
- Agree to contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of the investigational drug.
Who cannot join
- History of other primary malignancies.
- Received prohibited treatments as per the protocol.
- Untreated or unstable brain metastases, spinal metastases or compression, carcinomatous meningitis, or leptomeningeal metastases.
- Presence of ascites, pleural effusion, pericardial effusion that cannot be controlled by drainage methods, or subjects who require drainage to control third-space effusions within 14 days before dosing.
- Any severe or uncontrolled systemic disease, as judged by the investigator, including poorly controlled hypertension, uncontrolled diabetes, or signs of active bleeding.
- History of uncontrolled cardiac disease, including heart failure greater than NYHA Class II, unstable angina, myocardial infarction within the past year, clinically significant supraventricular or ventricular arrhythmias requiring treatment, or prolonged QT syndrome.
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- Evidence of active infection, including hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection; uncontrolled active bacterial, viral, fungal, rickettsial, or parasitic infections, unless treated and resolved before administration of the investigational drug.
- History of allergy to Pucotenlimab or any component of MRG002, or history of ≥Grade 3 allergic reaction to macromolecular protein preparations/monoclonal antibodies.
- History of primary immunodeficiency or active autoimmune disease, current use of immunosuppressive agents, or systemic corticosteroid therapy (≥10 mg/day prednisone or equivalent), and continued use within 2 weeks before enrollment.
- History of or concurrent interstitial pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- Positive serum pregnancy test or breastfeeding women who do not agree to adequate contraception during the study and for 6 months after receiving the investigational drug.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this clinical trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Zhiguo Luo, MD, (+86)-021-64175590, luozhiguo88@163.com
About this study
Official title: A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pucotenlimab in Combination with MRG002 in Treating HER2-positive Cancer of Unknown Primary
This study is a single-arm, open-label, multicenter Phase II clinical trial designed to observe and evaluate the efficacy and safety of Pucotenlimab in combination with MRG002 in patients with HER2-positive (IHC 2+ or 3+) cancer of unknown primary.
- Conditions
- Cancer of Unknown Primary
- Being tested
- Pucotenlimab combined with MRG002
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pucotenlimab combined with MRG002Drug
Pucotenlimab 200mg iv d1, Q3W MRG002 2.2mg/kg d1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Not described Receives: Drug: Pucotenlimab combined with MRG002 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
Measured: Time from the date of recruiting to the first recorded complete remission (CR) or partial remission (PR), assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start8 Mar 2025 (estimated)
- Primary completion8 Mar 2027 (estimated)
- Study completion8 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer of Unknown PrimaryStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhiguo Luo, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhiguo Luo, MD, PhD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869174
- Sponsor's protocol ID
- CUP 004
- Status last verified
- Mar 2025
- First submitted
- 5 Mar 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pucotenlimab in Combination with MRG002 in Treating HER2-positive Cancer of Unknown Primary
- ClinicalTrials.gov ID
- NCT06869174
- Acronym / sponsor ID
- CUP 004
- Conditions
- Cancer of Unknown Primary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhiguo Luo, MD, PhDUniversity, hospital or other
- Study start
- 8 Mar 2025 (estimated)
- Primary completion
- 8 Mar 2027 (estimated)
- Study completion
- 8 Aug 2028 (estimated)
- First posted
- 11 Mar 2025 (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 a single-arm, open-label, multicenter Phase II clinical trial designed to observe and evaluate the efficacy and safety of Pucotenlimab in combination with MRG002 in patients with HER2-positive (IHC 2+ or 3+) cancer of unknown primary.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Drug: Pucotenlimab combined with MRG002 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Voluntarily sign the informed consent form and comply with the protocol requirements.
- Subjects must be ≥18 years of age on the day of signing the informed consent form, with no gender restrictions.
- Expected survival of ≥3 months.
- Subjects with histologically confirmed squamous cell carcinoma, adenocarcinoma, or undifferentiated carcinoma of unknown primary origin by pathology laboratory, and who also meet the criteria of HER2 immunohistochemistry (IHC) 2+ or 3+. Subjects must have received at least one line of systemic therapy, including but not limited to targeted therapy, immunotherapy, chemotherapy, etc.
- Subjects must be able to provide a tumor specimen for pathological testing (paraffin block, paraffin-embedded sections, or fresh tissue sections are acceptable).
Key exclusion criteria (12 listed)
- History of other primary malignancies.
- Received prohibited treatments as per the protocol.
- Untreated or unstable brain metastases, spinal metastases or compression, carcinomatous meningitis, or leptomeningeal metastases.
- Presence of ascites, pleural effusion, pericardial effusion that cannot be controlled by drainage methods, or subjects who require drainage to control third-space effusions within 14 days before dosing.
- Any severe or uncontrolled systemic disease, as judged by the investigator, including poorly controlled hypertension, uncontrolled diabetes, or signs of active bleeding.
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 |
|---|---|---|
| Pucotenlimab combined with MRG002Pucotenlimab 200mg iv d1, Q3W MRG002 2.2mg/kg d1, Q3W | Drug | Treatment Arm |
Primary outcome
Overall response rate
Time frame: Time from the date of recruiting to the first recorded complete remission (CR) or partial remission (PR), assessed up to 12 months.
Defined as the percentage of participants in the analysis population who experienced a Complete Response or a Partial Response and was assessed using RECIST 1.1 based on investigator evaluation.
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 12 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pucotenlimab combined with MRG002 in people with Cancer of Unknown Primary, run by Zhiguo Luo, MD, PhD at 1 site in China.
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 11 inclusion and 12 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 12 Mar 2025. 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?
Contact Zhiguo Luo, MD ((+86)-021-64175590, luozhiguo88@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: Time from the date of recruiting to the first recorded complete remission (CR) or partial remission (PR), assessed up to 12 months.). 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 12 Mar 2025.