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

NCT ID: NCT07170787

Last Updated: 2025-09-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2029-07-31

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.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

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).

Group Type: EXPERIMENTAL

IMM2510

Intervention Type: 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).

IMM01

Intervention Type: 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).

Interventions

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).

Intervention Type: BIOLOGICAL

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).

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shanghai Gobroad Cancer Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality, China

Countries

China

Central Contacts

Jin Li Chief Scientist

Role: CONTACT

jin.li@gobroadhealthcare.com

+86 13761222111

Facility Contacts

Jin Li Chief Scientist

Role: primary

jin.li@gobroadhealthcare.com

+86 13761222111

Other Identifiers

ImmuneOncoBioShanghai

Identifier Type: -

Identifier Source: org_study_id