Advanced Solid TumorsPhase 1/2NCT07170787
A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors
A Phase 1/2 study testing IMM2510 and IMM01 in people with Advanced Solid Tumors, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- IMM2510 and IMM01
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2025to Jul 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Gobroad Cancer Hospital China Pharmaceutical University
Shanghai, Shanghai Municipality
Jin Li Chief Scientist, +86 13761222111, jin.li@gobroadhealthcare.com
About this study
Official title: Phase Ib/II Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in 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.
- Conditions
- Advanced Solid Tumors
- Being tested
- IMM2510, IMM01
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM2510Biological
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).
IMM01Biological
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Biological: IMM2510; Biological: IMM01 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT/MTD (Dose Escalation Phase)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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）
Measured: 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
Peak concentration (Cmax)
Measured: Up to approximately 1 year
Tmax
Peak time (Tmax)
Measured: Up to approximately 1 year
AUC0-tlast
Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t)
Measured: Up to approximately 1 year
AUC0-inf
Area under plasma concentration-time curve from 0 to infinite time
Measured: Up to approximately 1 year
t1/2
Elimination phase half-life (t1/2), in single dose period.
Measured: Up to approximately 1 year
CL
Clearance Rate
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study start15 Oct 2025 (estimated)
- Primary completionFeb 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170787
- Sponsor's protocol ID
- ImmuneOncoBioShanghai
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 12 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib/II Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07170787
- Acronym / sponsor ID
- ImmuneOncoBioShanghai
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- 15 Oct 2025 (estimated)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Biological: IMM2510, Biological: IMM01Dose 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMM2510IMM2510 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). | Biological | Cohort 1 |
| IMM01IMM01 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). | Biological | Cohort 1 |
Primary outcome
DLT/MTD (Dose Escalation Phase)
Time frame: 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)
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
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.
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
10 secondary outcomes
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.
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.
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.
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.
Cmax
Time frame: Up to approximately 1 year
Tmax
Time frame: Up to approximately 1 year
AUC0-tlast
Time frame: Up to approximately 1 year
AUC0-inf
Time frame: Up to approximately 1 year
t1/2
Time frame: Up to approximately 1 year
CL
Time frame: Up to approximately 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumors
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IMM2510 and IMM01 in people with Advanced Solid Tumors, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jin Li Chief Scientist (+86 13761222111, jin.li@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT/MTD (Dose Escalation Phase) (time frame: Within 28 days after the investigational products administration (within 56 days after first dosing of C1D1)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Sep 2025.