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IMM2510 and IMM01 Combination for Advanced Solid Tumors

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What is being tested

IMM2510

+ IMM01

Biological
Who is being recruted

From 18 to 75 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1 & 2
Interventional
Study Start: October 2025
See protocol details

Summary

Principal SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study ContactJin Li Chief Scientist
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 15, 2025

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new combination of drugs for patients with advanced solid tumors, which are types of cancer that have spread beyond their original site. The study aims to see how safe and tolerable two drugs, IMM2510 and IMM01, are when used together, as well as how they move through and affect the body. IMM2510 is a protein that targets proteins involved in cancer growth, while IMM01 is designed to help the immune system fight cancer cells. This research is especially important for patients who have already tried other treatments, as it explores a potential new option for managing their cancer. Participants in the study will receive the medications through injections. The study will gradually increase the dosage to find the most effective and safe amount for patients. Researchers will closely monitor participants to assess any side effects and gather information on how the drugs interact with the body and fight the tumor. The primary goal is to evaluate how well the treatment works against the cancer and to understand any potential risks involved. This study provides an opportunity to advance treatment options for individuals with challenging cancer types.

Official TitlePhase Ib/II Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in Advanced Solid Tumors
NCT07170787
Principal SponsorImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study ContactJin Li Chief Scientist
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

104 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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).

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Shanghai Gobroad Cancer Hospital China Pharmaceutical University

Shanghai, ChinaOpen Shanghai Gobroad Cancer Hospital China Pharmaceutical University in Google Maps
Recruiting soonOne Study Center