A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors

Condition(s) studied

Investigational drug(s) / intervention(s)

IMM2510: 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).

IMM01: 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).

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

More ImmuneOnco Biopharmaceuticals (Shanghai) Inc. trials in China

Other trials for the same condition