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

Not Applicable

Not yet recruiting

• Conditions: Advanced Solid Tumors
• Interventions: Biological: IMM2510; Biological: IMM01

• Registration Number: NCT07170787
• Lead Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-02
• Study First Submitted QC: 2025-09-11
• Last Update Submitted: 2025-09-11
• Study First Posted: 2025-09-12
• Last Update Posted: 2025-09-12
• Study Start: 2025-10-15
• Primary Completion: 2029-02
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cohort 1	IMM2510	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).
Cohort 1	IMM01	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Cmax	Up to approximately 1 year	Peak concentration (Cmax)
CL	Up to approximately 1 year	Clearance Rate
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.
Tmax	Up to approximately 1 year	Peak time (Tmax)
AUC0-tlast	Up to approximately 1 year	Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t)
AUC0-inf	Up to approximately 1 year	Area under plasma concentration-time curve from 0 to infinite time
t1/2	Up to approximately 1 year	Elimination phase half-life (t1/2), in single dose period.

Trial Locations

Locations (1)

Shanghai Gobroad Cancer Hospital China Pharmaceutical University; 🇨🇳 Shanghai, Shanghai Municipality, China