Advanced Solid Tumors
Conditions
Brief summary
This is a Phase 1, open-label, dose-escalation and cohort expansion study designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of IMM2510(Anti-PD-L1 and VEGF trap recombinant protein) combine with IMM01(Anti-CD47 Recombinant Protein) in patients with advanced solid tumors who have received at least first line treatment in past.
Interventions
BIOLOGICALIMM2510
IMM2510 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM2510 (e.g., 10 mg/kg, 20 mg/kg, up to maximum tolerated dose or recommended phase 2 dose).
BIOLOGICALIMM01
IMM01 administered intravenously once every 2 weeks (Q2W). Dose escalation cohorts will receive ascending doses of IMM01 (e.g., 1 mg/kg, 2 mg/kg, 3mg/kg, up to maximum tolerated dose or recommended phase 2 dose).
Sponsors
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Dose Escalation Phase: Participants will receive IMM2510 10 mg/kg or 20mg/kg and combine with IMM01 1.0 mg/kg , 2.0 mg/kg or 3.0 mg/kg dose every 2 weeks (Q2W). Dose Expansion Phase: The dose of IMM2510 and IMM01 for the dose expansion phase is determined according to the dose escalation results. Participants will receive IMM2510 and IMM01 every 2 weeks (Q2W).
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Participant has provided informed consent prior to initiation of any study specific activities/procedures. * Age greater than or equal to 18 years old at the same time of signing the informed consent. * Histologically or cytologically confirmed for Solid Tumor. * Eastern Cooperative Oncology Group (ECOG) 0 to 1. * Adequate organ function as defined in protocol.
Exclusion criteria
* History of other malignancy within the past 5 years with exceptions. * Systemic chemotherapy was administered within 3 weeks prior to the first administration. * Activated symptomatic brain metastases and leptomeningeal disease. * History of inflammatory bowel disease. * Participants with symptoms and/or clinical signs and/or uncontrolled active systemic infection within 14 days prior to the first dose of study treatment. Participant has known active infection requiring parenteral antibiotic treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT/MTD (Dose Escalation Phase) | Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1) |
| Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0) | 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 treatment |
| Objective Response Rate (ORR) | 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 years. |
| RP2D (Dose Extension Phase) | From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 96 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmax | Up to approximately 1 year | Peak concentration (Cmax) |
| Tmax | Up to approximately 1 year | Peak time (Tmax) |
| AUC0-tlast | Up to approximately 1 year | Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t) |
| Disease Control Rate(DCR) | 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 years. | — |
| t1/2 | Up to approximately 1 year | Elimination phase half-life (t1/2), in single dose period. |
| CL | Up to approximately 1 year | Clearance Rate |
| AUC0-inf | Up to approximately 1 year | Area under plasma concentration-time curve from 0 to infinite time |
| Duration of Response (DOR) | 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 years. | — |
| progression- free survival(PFS) | 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 years. | — |
| overall survival（OS） | 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 years. | — |
Countries
China
Contacts
Primary ContactJin Li Chief Scientist
Outcome results
None listed