A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.
About this trial
This study is an open-label, multi-centre, single-arm, phase I clinical study, to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510 (an anti-PD-L1/VEGF bispecific antibody fusion protein) + IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody) combination therapy in patients with advanced solid tumors.
Eligibility criteria
Qualifiers
The patient can understand the procedures and methods of this clinical trial. After giving full informed consent, the patient voluntarily participates in it and signs the informed consent form.
Aged between 18 and 75 years old (including both ends), regardless of gender.
Dose escalation phase: According to RECIST version 1.1, there should be at least one evaluable tumor lesion; Dose expansion phase: According to RECIST version 1.1, there should be at least one measurable tumor lesion.
ECOG performance status score of 0 - 1.
Disqualifiers
Patients who received mitomycin and nitrosourea chemotherapy within 6 weeks before the first administration.
Patients who received the last systemic anti-tumor treatment, including chemotherapy, radiotherapy, immunotherapy, biological agents or endocrine therapy, etc., within 4 weeks before the first administration.
Patients who received hormonal anti-tumor treatment or small molecule targeted therapy within 2 weeks before the first administration.
Patients who received local treatment such as radiotherapy for target lesions within 4 weeks before the first administration, and those who received palliative local treatment for non-target lesions within 2 weeks before the first administration.
Trial design
Treatments tested in this trial
- IMM27M
- IMM2510
Treatment groups
108 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov