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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
IMM27M
DrugIntravenous injection
IMM2510
DrugIntravenous injection
Treatment groups
108 Participants
are divided into 1 treatment groupGroup A: IMM2510 + IMM27M Combination TherapyExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
DLT/MTD (Dose Escalation Phase)
Incidence and characteristics of Dose-Limiting Toxicity (DLT) to determine the Maximum Tolerated Dose (MTD).
Time frame
Within 8 weeks after the investigational products administration (within 56 days after first dosing of C1D1)2
RP2D (Dose Extension Phase)
Recommended Phase II Dose (RP2D) of IMM27M and IMM2510, as the dose for efficacy study in Phase II, will be the dose with promising clinical responses observed in the patients, and well tolerated by patients.
Time frame
From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 48 weeks3
Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)
Incidence and characteristics of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period, were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
Time frame
From the first dose to 30 days after the last dose [90 days for SAEs and Immune-related Adverse Event (irAEs) ], or until beginning new anti-tumor treatmentSecondary outcomes
1
ORR
Objective Response Rate (ORR) is the proportion of patients with Complete Response (CR) or Partial Response (PR). ORR and other efficacy evaluation indexes are based on RECIST 1.1 criteria, the iRECIST criteria is supplemental only.
Time frame
From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years2
DCR
Disease control rate (DCR) is the proportion of patients with CR, PR, and Stable Disease (SD).
Time frame
From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years3
DOR
Duration of Response (DOR) is the time between the first onset of CR or PR and the first onset of Disease Progression (PD) or death from any cause. For patients with unknown progression or death, the time of sustained remission was censored at the time point of the last patient evaluation.
Time frame
From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 years4
PFS
Progression-Free Survival (PFS) is the time between first initiation of study treatment to PD or death due to any reason. For patients with unknown progression or death, disease-free survival was censored at the time point of the last patient evaluation.
Time frame
From date of first dose until the date of first documented progression, death from any cause, loss of follow-up, withdrawal of informed consent, or study termination by the sponsor, whichever came first, assessed up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov