Not yet recruiting NCT07170787
A Study of IMM2510 + IMM01 Combination Therapy in Patients With Advanced Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMM2510, IMM01.
- Who it may be relevant to
- Registry conditions: Advanced Solid Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase Ib/II Clinical Study of IMM2510 for Injection Combined With IMM01 for Injection in Advanced Solid Tumors
Overview
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.
Interventions
- Biological IMM2510
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). - Biological IMM01
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 outcome measures
- 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]
Secondary outcome measures (10)
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai Gobroad Cancer Hospital China Pharmaceutical University — Shanghai
Identifiers
NCT: NCT07170787 · ImmuneOncoBioShanghai