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

NCT07170787 | Not Yet Recruiting Phase 1

• 1 other identifier: ImmuneOncoBioShanghai
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (10)

• 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)

  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

  Up to approximately 1 year

Study Arms (1)

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).

Biological: IMM2510; Biological: IMM01

Interventions

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).

Cohort 1

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).

Cohort 1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

Study Sites (1)

Shanghai Gobroad Cancer Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality, China

Location

Central Study Contacts

Jin Li Chief Scientist

CONTACT

+86 13761222111; jin.li@gobroadhealthcare.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 12, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)