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

ImmuneOnco Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Advanced Solid Tumors

Treatments: Biological: IMM01; Biological: IMM2510

Study type: Interventional

Funder types: Other

Identifiers

NCT07170787

ImmuneOncoBioShanghai

Details and patient eligibility

About

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.

Enrollment: 104 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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104 participants in 1 patient group

Cohort 1

Experimental group

Description:

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).

Treatment:

Biological: IMM2510

Biological: IMM01