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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Dose Escalation Phase: Participants will receive IMM2510 10.0 mg/kg or 20.0 mg/kg dose every 2 weeks (Q2W), and will receive IMM01 1.0 mg/kg,2.0 mg/kg or 3.0 mg/kg dose every 2 weeks (Q2W). Cohort Expansion Phase: The dose of IMM2510 and IMM01 for the cohort expansion phase is determined according to the dose escalation results. Participants will receive IMM2510 and IMM01 every 2 weeks (Q2W). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM2510 | Biological | 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). |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | |
| Duration of Response (DOR) |
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Inclusion Criteria:
Exclusion Criteria:
Participant has known active infection requiring parenteral antibiotic treatment.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jin Li Chief Scientist | Contact | +86 13761222111 | jin.li@gobroadhealthcare.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Gobroad Cancer Hospital China Pharmaceutical University | Shanghai | Shanghai Municipality | China |
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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).
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| IMM01 | Biological | 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). |
|
| 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. |
| Cmax | Peak concentration (Cmax) | Up to approximately 1 year |
| Tmax | Peak time (Tmax) | Up to approximately 1 year |
| AUC0-tlast | Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t) | Up to approximately 1 year |
| AUC0-inf | Area under plasma concentration-time curve from 0 to infinite time | Up to approximately 1 year |
| t1/2 | Elimination phase half-life (t1/2), in single dose period. | Up to approximately 1 year |
| CL | Clearance Rate | Up to approximately 1 year |