Pucotenlimab Combined with MRG002 for HER2-positive Cancer of Unknown Primary

ConditionCancer of Unknown Primary

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorZhiguo Luo, MD, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

Pucotenlimab combined with MRG002
Drug
Pucotenlimab 200mg iv d1, Q3W MRG002 2.2mg/kg d1, Q3W

Treatment groups

50 Participants

are divided into 1 treatment group

Group A: Treatment ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Time from the date of recruiting to the first recorded complete remission (CR) or partial remission (PR), assessed up to 12 months.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhiguo Luo, MD, PhD

Lead sponsor

Fudan University

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: