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NCT Number: NCT07170787

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

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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Key information

Conditions

Advanced Solid Tumors

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Shanghai Gobroad Cancer Hospital China Pharmaceutical University

Shanghai, Shanghai Municipality, China

Location contact

Jin Li Chief Scientist

CONTACT

[email protected]

+86 13761222111

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

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).

Primary outcomes

  1. DLT/MTD (Dose Escalation Phase)

    Time frame: Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1)

  2. Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)

    Time frame: 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

  3. Objective Response Rate (ORR)

    Time frame: 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.

  4. RP2D (Dose Extension Phase)

    Time frame: 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

  1. Disease Control Rate(DCR)

    Time frame: 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.

  2. Duration of Response (DOR)

    Time frame: 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.

  3. progression- free survival(PFS)

    Time frame: 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.

  4. overall survival（OS）

    Time frame: 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.

  5. Cmax

    Time frame: Up to approximately 1 year

    Peak concentration (Cmax)

  6. Tmax

    Time frame: Up to approximately 1 year

    Peak time (Tmax)

  7. AUC0-tlast

    Time frame: Up to approximately 1 year

    Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t)

  8. AUC0-inf

    Time frame: Up to approximately 1 year

    Area under plasma concentration-time curve from 0 to infinite time

  9. t1/2

    Time frame: Up to approximately 1 year

    Elimination phase half-life (t1/2), in single dose period.

  10. CL

    Time frame: Up to approximately 1 year

    Clearance Rate

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Li Chief Scientist

CONTACT

[email protected]

+86 13761222111

Sponsors and collaborators

Lead sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Other

Registry information

Official study title

Phase Ib/II Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in Advanced Solid Tumors

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Sep 12, 2025
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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