Advanced Solid TumorsPhase 1NCT06764836
A Study of IMM2510 + IMM27M Combination Therapy in Patients With Advanced Solid Tumors
A Phase 1 study testing IMM27M and IMM2510 in people with Advanced Solid Tumors and HCC, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 1 site in China.
Trial summary
This study is an open-label, multi-centre, single-arm, phase I clinical study, to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510 (an anti-PD-L1/VEGF bispecific antibody fusion protein) + IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody) combination therapy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors, HCC
- What is being tested?
- IMM27M and IMM2510
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteChina
- Study dates
- 23 Jul 2024to 27 Jan 2026
- Phase
- Phase 1
- 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
- The patient can understand the procedures and methods of this clinical trial. After giving full informed consent, the patient voluntarily participates in it and signs the informed consent form.
- Aged between 18 and 75 years old (including both ends), regardless of gender.
- Clinical diagnosis:
- Dose escalation phase: Patients with advanced malignant solid tumors confirmed by histology or cytology, who have failed previous standard treatments, have no standard treatment regimens or are not suitable for standard treatment at present, including but not limited to hepatocellular carcinoma, triple-negative breast cancer, soft tissue sarcoma, non-small cell lung cancer, epithelial ovarian cancer, small cell lung cancer, malignant melanoma, colorectal cancer, ovarian cancer, endometrial cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, etc.
- Dose expansion phase: The following tumor types are included: a. Patients with advanced hepatocellular carcinoma who have failed or could not tolerate at least one line of previous systemic treatment; b. Patients with locally advanced, unresectable or metastatic triple-negative breast cancer confirmed by histology or cytology, who have failed or could not tolerate at least one line of previous systemic treatment; c. Patients with other advanced malignant solid tumors (except those with triple-negative breast cancer and advanced hepatocellular carcinoma) confirmed by histology or cytology, who have failed or could not tolerate at least one line of previous systemic treatment, including but not limited to soft tissue sarcoma, non-small cell lung cancer, epithelial ovarian cancer, small cell lung cancer, malignant melanoma, colorectal cancer, ovarian cancer, endometrial cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, etc.
- Dose escalation phase: According to RECIST version 1.1, there should be at least one evaluable tumor lesion; Dose expansion phase: According to RECIST version 1.1, there should be at least one measurable tumor lesion.
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- ECOG performance status score of 0 - 1.
- The expected survival time is more than 3 months.
- There should be sufficient organ function. Hematological system (without receiving blood transfusion or hematopoietic stimulating factor treatment within 14 days): Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L, Platelet count (PLT) ≥ 100 × 10⁹/L, Hemoglobin (Hb) ≥ 90 g/L. For patients with HCC accompanied by liver cirrhosis, ANC ≥ 1.0 × 10⁹/L and platelet count ≥ 90 × 10⁹/L are acceptable for enrollment.
- Liver function: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN), for patients with liver metastasis or liver cancer, TBIL ≤ 3.0 × ULN; Alanine aminotransferase (ALT) ≤ 2.5 × ULN, for patients with liver metastasis or liver cancer, ALT ≤ 5.0 × ULN; Aspartate aminotransferase (AST) ≤ 2.5 × ULN, for patients with liver metastasis or liver cancer, AST ≤ 5.0 × ULN.
- Renal function: Creatinine clearance rate (Ccr) ≥ 50 ml/min (calculated according to the Cockcroft-Gault formula), Urinary protein < 2+ or 24-hour urinary protein quantification < 1.0 g.
- Coagulation function: Prothrombin time (PT) ≤ 1.5 × ULN, Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN, International normalized ratio (INR) ≤ 1.5 × ULN.
- Cardiac function: 12-lead electrocardiogram, QTc interval ≤ 480 ms, Echocardiogram, Left ventricular ejection fraction (LVEF) ≥ 50%.
- Thyroid function: Thyroid-stimulating hormone (TSH) ≤ 1 × ULN (if abnormal, FT3 and FT4 levels should be observed simultaneously. If FT3 and FT4 levels are normal, enrollment is allowed).
- Liver function grading for HCC patients: Child-Pugh score ≤ 7 points.
- Qualified patients (both male and female) with fertility must agree to use reliable contraceptive methods (hormonal or barrier methods or abstinence) together with their partners during the trial period and at least 6 months after the last administration.
- The patient must be informed of this study before the trial and voluntarily sign the written informed consent form.
Who cannot join
- Patients meeting any one of the following criteria will be excluded from this study:
- Previous treatment history:
- Patients who received mitomycin and nitrosourea chemotherapy within 6 weeks before the first administration.
- Patients who received the last systemic anti-tumor treatment, including chemotherapy, radiotherapy, immunotherapy, biological agents or endocrine therapy, etc., within 4 weeks before the first administration.
- Patients who received hormonal anti-tumor treatment or small molecule targeted therapy within 2 weeks before the first administration.
- Patients who received local treatment such as radiotherapy for target lesions within 4 weeks before the first administration, and those who received palliative local treatment for non-target lesions within 2 weeks before the first administration.
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- Patients who received non-specific immunomodulatory treatment (such as interleukin, interferon, thymosin, tumor necrosis factor, etc., excluding IL-11 used for treating thrombocytopenia) within 2 weeks before the first administration.
- Patients who previously received the experimental drugs IMM2510 and/or IMM27M; those who could not tolerate treatment with anti-CTLA-4 or PD-1/L1 inhibitors (due to toxic and side effects); those who previously used drugs targeting three targets, namely anti-PD-1/L1, VEGF, and CTLA-4 simultaneously in the same regimen.
- Patients who received traditional Chinese medicine with anti-tumor indications within 1 week before the first administration.
- Patients who participated in other clinical trials within 4 weeks before the first administration.
- Those with a known severe allergic history to any component of the experimental drug, or those with a history of severe allergic reactions to chimeric or humanized antibodies or fusion proteins.
- Those who had any immune-related adverse events (irAE) of grade ≥ 3 in CTCAE V5.0 or that led to the termination of immunotherapy during previous treatment with any immunotherapy drugs.
- Those diagnosed with other malignant tumors within 5 years before enrollment. Exceptions: 1) Cervical carcinoma in situ and non-melanoma skin cancer that have been cured; 2) Patients who have been radically cured, unless the patients have been in complete remission for at least 2 years before enrollment and do not require other treatments or will not require other treatments during the study period.
- Those with an active second primary cancer that is known and has had no recurrence within 5 years. Exceptions: 1) The investigator believes that both primary cancers can benefit from this study; 2) The investigator has clearly excluded which primary tumor the metastatic lesions belong to.
- Patients with primary central nervous system (CNS) malignant tumors or those with active CNS metastases that failed local treatment (radiotherapy or surgical treatment). However, the following patients are allowed to enroll: a. Patients with asymptomatic brain metastases; b. Patients with clinically stable symptoms (i.e., no radiological progression was seen within 4 weeks before the first administration, and any neurological symptoms have returned to the baseline level), and who have not required corticosteroid hormones and other treatments for brain metastases for ≥ 4 weeks.
- Patients with hypertension that cannot be controlled by drugs (systolic blood pressure remains > 140 mmHg or diastolic blood pressure > 90 mmHg after standard treatment), or with pulmonary hypertension or unstable angina pectoris; those who had a myocardial infarction or underwent bypass or stent surgery within 6 months before administration; those with a history of chronic heart failure of grade 3 - 4 according to the New York Heart Association (NYHA) criteria; those with clinically significant valvular diseases; those with severe arrhythmias requiring treatment (except atrial fibrillation and paroxysmal supraventricular tachycardia), including QTcF ≥ 450 ms for men and ≥ 470 ms for women (calculated by the Fridericia formula); those with cerebrovascular accidents (CVA) or transient ischemic attacks (TIA), etc., within 12 months before enrollment.
- Those with a history of arterial thrombosis, deep vein thrombosis or pulmonary embolism within 3 months before administration.
- Those with a history of moderate or severe dyspnea at rest due to advanced malignant tumors or their complications or severe primary lung diseases, or those currently requiring continuous oxygen inhalation treatment, or those with a history of interstitial lung disease (ILD) or pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency, symptomatic bronchospasm, etc.
- Those with diseases that may cause gastrointestinal bleeding or perforation (such as duodenal ulcer, intestinal obstruction, acute Crohn's disease, ulcerative colitis, extensive resection of the stomach and small intestine, etc.); patients with chronic Crohn's disease and ulcerative colitis (except those who have undergone total colectomy and rectal resection) should be excluded even during the inactive period; those with hereditary non-polyposis colorectal cancer or familial adenomatous polyposis syndrome; those with a history of intestinal perforation or intestinal fistula that have not been cured after surgical treatment; esophageal and gastric varices; or the presence of cancer thrombus in the main portal vein; those requiring repeated drainage due to uncontrollable thoracic, abdominal or pericardial effusion that requires puncture and drainage treatment or those with obvious symptoms.
- Those with evidence of severe active infections that cannot be controlled (such as sepsis, bacteremia, viremia, etc.).
- Those with active tuberculosis infection.
- Those with active hepatitis B (HBsAg positive, and HBV DNA higher than the lower limit of detection, and excluding hepatitis caused by drugs or other reasons), or those with active hepatitis C (anti-HCV antibody positive, and HCV RNA higher than the lower limit of detection).
- Those with a history of immunodeficiency, including human immunodeficiency virus (HIV) infection, or other immunodeficiency diseases, or those with a history of organ transplantation or hematopoietic stem cell transplantation.
- Those with a history of active autoimmune diseases, including but not limited to systemic lupus erythematosus, psoriasis, rheumatoid arthritis, inflammatory bowel diseases, Hashimoto's thyroiditis, autoimmune thyroid diseases, multiple sclerosis, etc. Exceptions:
- Hypothyroidism that can be controlled only by hormone replacement therapy.
- Skin diseases that do not require systemic treatment (such as vitiligo, psoriasis).
- Controlled celiac disease.
- Those who are currently using immunosuppressants or systemic hormone therapy (prednisone at a dose of ≥ 10 mg/day or other equivalent hormones) and are still using them within 2 weeks before enrollment.
- Those who underwent major surgery within 4 weeks before the first administration and have not fully recovered, or those who plan to undergo major surgery within the first 12 weeks after receiving the study drug; those who received minor surgical operations 2 days before enrollment.
- Those with incompletely healed skin wounds, surgical sites, trauma sites, severe mucosal ulcers or fractures, and whom the investigator judges to be at risk of bleeding if participating in this study.
- Those who received anti-tumor vaccines or live vaccines within 4 weeks before the first administration, or those who plan to receive anti-tumor vaccines or live vaccines during the study period.
- Those with a clear history of neurological or mental disorders in the past, such as epilepsy, dementia, and with poor compliance.
- Patients with a history of alcoholism or drug abuse within the past year, or with a history of fainting during acupuncture or blood drawing, or those who cannot tolerate venipuncture for blood collection.
- Women who are pregnant or breastfeeding; those who do not agree to take sufficient contraceptive measures together with their partners during the study period and within 6 months after the end of receiving the experimental drug.
- The investigator believes that there are other reasons why the patient is not suitable to participate in this trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qiying Lu, M.D. contact
China1 site, 1 recruiting
- Recruiting
ZhongShan Hospital Fudan University
Shanghai, Shanghai Municipality
Yiyi Yu, +86-13816725978, yu.yiyi@zs-hospital.sh.cn
Tianshu Liu, M.D., +86-13681973996, liu.tianshu@zs-hospital.sh.cn
About this study
Official title: An Open-Label, Multi-Centre, Single-Arm, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of IMM2510 in Combination With IMM27M in Patients With Advanced Solid Tumors
This study is an open-label, multi-centre, single-arm, phase I clinical study, to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510 (an anti-PD-L1/VEGF bispecific antibody fusion protein) + IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody) combination therapy in patients with advanced solid tumors.
Read the detailed description
Dose Escalation Phase: 3+3 Dose escalation design of IMM27M + IMM2510 combination therapy in advanced solid tumors.
Dose Expansion Phase: Recommended dose for expansion (RDE) of IMM27M + IMM2510 combination therapy in three cohorts: cohort 1: locally advanced unresectable or metastatic triple-negative breast cancer (those with at least first-line systemic treatment failure or intolerance); cohort 2: advanced hepatocellular carcinoma (patients with at least first-line systemic therapy failure or intolerance); cohort 3: other advanced solid tumors (those with at least first-line systemic treatment failure or intolerance).
- Conditions
- Advanced Solid Tumors, HCC
- Being tested
- IMM27M, IMM2510
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM27MDrug
Intravenous injection
IMM2510Drug
Intravenous injection
| Study group | Role | What they receive |
|---|---|---|
| IMM2510 + IMM27M Combination Therapy | Experimental | Dose Escalation Phase:
Participants will receive IMM27M 3.0 mg/kg single dose on day 1 (C1D1), and after a 4-week interval, will receive IMM2510 10.0 mg/kg or 20.0 mg/kg dose every 2 weeks (Q2W).
Dose Expansion Phase:
The dose of IMM27M and IMM2510 for the dose expansion phase is determined according to the dose escalation results.
Participants will receive IMM27M single dose on day 1 (C1D1), and after a 4-week interval, will receive IMM2510 every 2 weeks (Q2W). Receives: Drug: IMM27M; Drug: IMM2510 |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT/MTD (Dose Escalation Phase)
Incidence and characteristics of Dose-Limiting Toxicity (DLT) to determine the Maximum Tolerated Dose (MTD).
Measured: Within 8 weeks after the investigational products administration (within 56 days after first dosing of C1D1)
RP2D (Dose Extension Phase)
Recommended Phase II Dose (RP2D) of IMM27M and IMM2510, as the dose for efficacy study in Phase II, will be the dose with promising clinical responses observed in the patients, and well tolerated by patients.
Measured: From the first dose until disease progresses or end of treatment for other reasons, the maximum treatment duration is not more than 48 weeks
Incidence and characteristics of AEs and SAEs (according to NCI CTCAE 5.0)
Incidence and characteristics of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period, were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
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
Secondary outcomes (16)
ORR
Objective Response Rate (ORR) is the proportion of patients with Complete Response (CR) or Partial Response (PR). ORR and other efficacy evaluation indexes are based on RECIST 1.1 criteria, the iRECIST criteria is supplemental only.
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
DCR
Disease control rate (DCR) is the proportion of patients with CR, PR, and Stable Disease (SD).
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
DOR
Duration of Response (DOR) is the time between the first onset of CR or PR and the first onset of Disease Progression (PD) or death from any cause. For patients with unknown progression or death, the time of sustained remission was censored at the time point of the last patient evaluation.
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
PFS
Progression-Free Survival (PFS) is the time between first initiation of study treatment to PD or death due to any reason. For patients with unknown progression or death, disease-free survival was censored at the time point of the last patient evaluation.
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
OS
Overall Survival (OS) is defined as the time interval from the date of the first dose of study drug to the date of death from any cause.
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), in single dose period.
Measured: Up to approximately 1 year
Tmax
Peak time (Tmax), in single dose period.
Measured: Up to approximately 1 year
t1/2
Elimination phase half-life (t1/2), in single dose period.
Measured: Up to approximately 1 year
AUC0-t
Area under plasma concentration-time curve from 0 to the last quantifiable time point (AUC0-t), in single dose period.
Measured: Up to approximately 1 year
AUC0-∞
Area under plasma concentration-time curve from 0 to infinite time (AUC0-∞), in single dose period.
Measured: Up to approximately 1 year
Cmin, ss
Steady-state trough concentration (Cmin, ss), in multiple dose periods.
Measured: Up to approximately 1 year
Cmax, ss
Steady-state peak concentration (Cmax, ss), in multiple dose periods.
Measured: Up to approximately 1 year
Tmax, ss
Steady-state peak time (Tmax, ss), in multiple dose periods.
Measured: Up to approximately 1 year
t1/2, ss
Steady-state half-life (t1/2, ss), in multiple dose periods.
Measured: Up to approximately 1 year
Cav, ss
Mean plasma concentration at steady state (Cav, ss), in multiple dose periods.
Measured: Up to approximately 1 year
ADA and NAb
For each patient, the presence of Anti-drug Antibody (ADA) will be assessed, and ADA positive patients need to be measured for titers and Neutralizing Antibodies (NAb).
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 posted8 Jan 2025
- Study start23 Jul 2024
- Primary completion27 Jan 2026 (estimated)
- Study completion27 Jan 2026 (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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 108 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
- NCT06764836
- Sponsor's protocol ID
- IMM2510-002
- Status last verified
- Jan 2025
- First submitted
- 22 Dec 2024
- Last updated
- 8 Jan 2025
- Results posted
- No
- Data monitoring committee
- 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 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Centre, Single-Arm, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Efficacy of IMM2510 in Combination With IMM27M in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06764836
- Acronym / sponsor ID
- IMM2510-002
- Conditions
- Advanced Solid Tumors, HCC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- 23 Jul 2024 (actual)
- Primary completion
- 27 Jan 2026 (estimated)
- Study completion
- 27 Jan 2026 (estimated)
- First posted
- 8 Jan 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 study is an open-label, multi-centre, single-arm, phase I clinical study, to evaluate the safety, tolerability, efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of IMM2510 (an anti-PD-L1/VEGF bispecific antibody fusion protein) + IMM27M (a humanized Fc-engineered anti-CTLA-4 antibody) combination therapy in patients with advanced solid tumors.
Detailed description
Dose Escalation Phase: 3+3 Dose escalation design of IMM27M + IMM2510 combination therapy in advanced solid tumors.
Dose Expansion Phase: Recommended dose for expansion (RDE) of IMM27M + IMM2510 combination therapy in three cohorts: cohort 1: locally advanced unresectable or metastatic triple-negative breast cancer (those with at least first-line systemic treatment failure or intolerance); cohort 2: advanced hepatocellular carcinoma (patients with at least first-line systemic therapy failure or intolerance); cohort 3: other advanced solid tumors (those with at least first-line systemic treatment failure or intolerance).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMM2510 + IMM27M Combination Therapy | Experimental | Drug: IMM27M, Drug: IMM2510Dose Escalation Phase: Participants will receive IMM27M 3.0 mg/kg single dose on day 1 (C1D1), and after a 4-week interval, will receive IMM2510 10.0 mg/kg or 20.0 mg/kg dose every 2 weeks (Q2W). Dose Expansion Phase: The dose of IMM27M and IMM2510 for the dose expansion phase is determined according to the dose escalation results. Participants will receive IMM27M single dose on day 1 (C1D1), and after a 4-week interval, will receive IMM2510 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 (17 listed)
- The patient can understand the procedures and methods of this clinical trial. After giving full informed consent, the patient voluntarily participates in it and signs the informed consent form.
- Aged between 18 and 75 years old (including both ends), regardless of gender.
- Clinical diagnosis:
- Dose escalation phase: Patients with advanced malignant solid tumors confirmed by histology or cytology, who have failed previous standard treatments, have no standard treatment regimens or are not suitable for standard treatment at present, including but not limited to hepatocellular carcinoma, triple-negative breast cancer, soft tissue sarcoma, non-small cell lung cancer, epithelial ovarian cancer, small cell lung cancer, malignant melanoma, colorectal cancer, ovarian cancer, endometrial cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, etc.
- Dose expansion phase: The following tumor types are included: a. Patients with advanced hepatocellular carcinoma who have failed or could not tolerate at least one line of previous systemic treatment; b. Patients with locally advanced, unresectable or metastatic triple-negative breast cancer confirmed by histology or cytology, who have failed or could not tolerate at least one line of previous systemic treatment; c. Patients with other advanced malignant solid tumors (except those with triple-negative breast cancer and advanced hepatocellular carcinoma) confirmed by histology or cytology, who have failed or could not tolerate at least one line of previous systemic treatment, including but not limited to soft tissue sarcoma, non-small cell lung cancer, epithelial ovarian cancer, small cell lung cancer, malignant melanoma, colorectal cancer, ovarian cancer, endometrial cancer, renal cell carcinoma, squamous cell carcinoma of the head and neck, etc.
Key exclusion criteria (35 listed)
- Previous treatment history:
- Those with a known severe allergic history to any component of the experimental drug, or those with a history of severe allergic reactions to chimeric or humanized antibodies or fusion proteins.
- Those who had any immune-related adverse events (irAE) of grade ≥ 3 in CTCAE V5.0 or that led to the termination of immunotherapy during previous treatment with any immunotherapy drugs.
- Those diagnosed with other malignant tumors within 5 years before enrollment. Exceptions: 1) Cervical carcinoma in situ and non-melanoma skin cancer that have been cured; 2) Patients who have been radically cured, unless the patients have been in complete remission for at least 2 years before enrollment and do not require other treatments or will not require other treatments during the study period.
- Those with an active second primary cancer that is known and has had no recurrence within 5 years. Exceptions: 1) The investigator believes that both primary cancers can benefit from this study; 2) The investigator has clearly excluded which primary tumor the metastatic lesions belong to.
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 |
|---|---|---|
| IMM27MIntravenous injection | Drug | IMM2510 + IMM27M Combination Therapy |
| IMM2510Intravenous injection | Drug | IMM2510 + IMM27M Combination Therapy |
Primary outcome
DLT/MTD (Dose Escalation Phase)
Time frame: Within 8 weeks after the investigational products administration (within 56 days after first dosing of C1D1)
Incidence and characteristics of Dose-Limiting Toxicity (DLT) to determine the Maximum Tolerated Dose (MTD).
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 48 weeks
Recommended Phase II Dose (RP2D) of IMM27M and IMM2510, as the dose for efficacy study in Phase II, will be the dose with promising clinical responses observed in the patients, and well tolerated by patients.
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
Incidence and characteristics of Adverse Events (AEs) and Serious Adverse Events (SAEs) throughout the study period, were evaluated according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0.
16 secondary outcomes
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
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
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
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
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
t1/2
Time frame: Up to approximately 1 year
AUC0-t
Time frame: Up to approximately 1 year
AUC0-∞
Time frame: Up to approximately 1 year
Cmin, ss
Time frame: Up to approximately 1 year
Cmax, ss
Time frame: Up to approximately 1 year
Tmax, ss
Time frame: Up to approximately 1 year
t1/2, ss
Time frame: Up to approximately 1 year
Cav, ss
Time frame: Up to approximately 1 year
ADA and NAb
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 8 Jan 2025.
- Individual participant dataSharing planned: No
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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.
Qiying Lu, M.D. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IMM27M and IMM2510 in people with Advanced Solid Tumors and HCC, 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 17 inclusion and 35 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: looking for participants now, as of the sponsor's last update on 8 Jan 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 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.
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 Deqiang Jing, M.D., Ph.D (+86-021-38016378, deqiang.jing@immuneonco.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 8 weeks after the investigational products administration (within 56 days after first dosing of C1D1)). The study lists 3 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 8 Jan 2025.