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
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
Treatments tested in this trial
- Pucotenlimab combined with MRG002
Treatment groups
50 Participants
are divided into 1 treatment groupSponsors and collaborators
Zhiguo Luo, MD, PhD
Lead sponsor
Fudan University
Sponsor institution
Source ClinicalTrials.gov