Solid TumorPhase 1/2NCT05833984
Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
A Phase 1/2 study testing IMM01 and Tislelizumab in people with Solid Tumor and Classic Hodgkin Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 5 sites in China.
Trial summary
This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Classic Hodgkin Lymphoma
- What is being tested?
- IMM01 and Tislelizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 309 participants
- Where
- 5 sitesChina
- Study dates
- 17 May 2022to 20 Nov 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, male or female
- Life expectancy≥12 weeks;
- Phase 1b: Patients with advanced solid tumors diagnosed by histology or cytology, who have been failure to previous standard treatments; Phase 2: Patients with HNSCC, NPC, OC, NSCLC, SCLC, HCC, cHL and other solid tumors diagnosed by histology or cytology, who have been failure to first-line standard treatment (including PD-1/L1) at least;
- ECOG PS of 0 or 1;
- Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation.
- Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0);
Who cannot join
- Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein;
- Patients with symptomatic or progressive central nervous system (CNS) metastasis;
- Uncontrolled hypertension, pulmonary hypertension or unstable angina, myocardial infarction within 6 months prior to administration; a history of chronic heart failure (NYHA G3/4); severe arrhythmia;
- A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration;
- A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency;
- With other malignant tumors;
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- Diseases that may cause gastrointestinal bleeding or perforation;
- Uncontrollable pleural, peritoneal or pericardial effusions;
- A history of immunodeficiency;
- A history of autoimmune diseases;
- Uncontrolled severe active infections.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
Xuan Zheng, xuan.zheng@immuneonco.com
Zhengbo Song, M.D.
- Recruiting
Shandong Provincial Institute of Cancer Prevention and Treatment
Jinan
Xuan Zheng, xuan.zheng@immuneonco.com
Yan Zhang, M.D.
- Recruiting
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar
Jiaqi Yang, jiaqi.yang@immuneonco.com
Xu Tong, M.D.
- Recruiting
Shanghai Chest Hospital
Shanghai
Xuan Zheng, xuan.zheng@immuneonco.com
Shun Lu, Ph.D.
- Recruiting
Henan Cancer Hospital
Zhengzhou
Rongqiang Sun, rongqiang.sun@immuneonco.com
Yanqiu Zhao, M.D.
About this study
Official title: A Phase 1b/2 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
This is an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.
Read the detailed description
This open-label, multicenter, phase 1b/2 trial is conducted to evaluate the safety, tolerability and preliminary activity in patients with advanced solid tumors and lymphomas. This trial includes two parts: the phase 1b dose escalation part and the phase 2 dose expansion part.
In the dose escalation part with a standard 3+3 design, IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks.
In the dose expansion part, IMM01 (the dose determined in the dose escalation part) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. And the cohorts includes HNSCC, NSCLC, SCLC, R/R cHL and others.
- Conditions
- Solid Tumor, Classic Hodgkin Lymphoma
- Being tested
- IMM01, Tislelizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMM01Drug
Also called SIRPα Fc
IMM01 (1.0, 1.5, 2.0 mg/kg) QW IV in the dose escalation part. IMM01 (dose determined in the dose escalation part) QW IV in the dose expansion part.
TislelizumabDrug
Tislelizumab 200mg Q3W IV
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation Part | Experimental | Mutiple dose level cohorts in the dose escalation part Receives: Drug: IMM01; Drug: Tislelizumab |
| Head and neck squamous cell carcinoma, nasopharyngeal carcinoma | Experimental | Dose expansion cohort with IMM01 plus Tislelizumab Receives: Drug: IMM01; Drug: Tislelizumab |
| Ovarian carcinoma | Experimental | Dose expansion cohort with IMM01 plus Tislelizumab Receives: Drug: IMM01; Drug: Tislelizumab |
| Non small cell lung carcinoma, small cell lung carcinoma | Experimental | Dose expansion cohort with IMM01 plus Tislelizumab Receives: Drug: IMM01; Drug: Tislelizumab |
| Hepatocellular carcinoma | Experimental | Dose expansion cohort with IMM01 plus Tislelizumab Receives: Drug: IMM01; Drug: Tislelizumab |
| Other solid tumors | Experimental | Dose expansion cohort with IMM01 plus Tislelizumab Receives: Drug: IMM01; Drug: Tislelizumab |
| Classic hodgkin lymphoma | Experimental | Dose expansion cohort with IMM01 plus Tislelizumab Receives: Drug: IMM01; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity in dose escalation part
Measured: DLT observation 21 days
MTD/RP2D in dose escalation part
Measured: DLT observation 21 days
ORR in dose expansion part
Measured: up to 12 months
Secondary outcomes (8)
TRAEs
Measured: up to 12 months
PFS
Measured: up to 12 months
DOR
Measured: up to 12 months
DCR
Measured: up to 12 months
Cmax
Measured: up to 12 months
T1/2
Measured: up to 12 months
AUC
Measured: up to 12 months
ADA
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start17 May 2022
- Primary completion7 Feb 2024 (estimated)
- Study completion20 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 309 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
- NCT05833984
- Sponsor's protocol ID
- IMM01-04
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Dose Escalation and Expansion Study Evaluating the Safety, Tolerability, and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas
- ClinicalTrials.gov ID
- NCT05833984
- Acronym / sponsor ID
- IMM01-04
- Conditions
- Solid Tumor, Classic Hodgkin Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 309 participants (estimated)
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.University, hospital or other
- Study start
- 17 May 2022 (actual)
- Primary completion
- 7 Feb 2024 (estimated)
- Study completion
- 20 Nov 2024 (estimated)
- First posted
- 27 Apr 2023 (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 an open-label, multicenter, phase 1b/2 trial of IMM01 (SIRPα Fc) plus tislelizumab in patients with advanced solid tumors and lymphomas.
Detailed description
This open-label, multicenter, phase 1b/2 trial is conducted to evaluate the safety, tolerability and preliminary activity in patients with advanced solid tumors and lymphomas. This trial includes two parts: the phase 1b dose escalation part and the phase 2 dose expansion part.
In the dose escalation part with a standard 3+3 design, IMM01 (1.0, 1.5, 2.0 mg/kg) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks.
In the dose expansion part, IMM01 (the dose determined in the dose escalation part) was administered once a week and tislelizumab (200mg) was administered once every 3 weeks. And the cohorts includes HNSCC, NSCLC, SCLC, R/R cHL and others.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation Part | Experimental | Drug: IMM01, Drug: TislelizumabMutiple dose level cohorts in the dose escalation part |
| Head and neck squamous cell carcinoma, nasopharyngeal carcinoma | Experimental | Drug: IMM01, Drug: TislelizumabDose expansion cohort with IMM01 plus Tislelizumab |
| Ovarian carcinoma | Experimental | Drug: IMM01, Drug: TislelizumabDose expansion cohort with IMM01 plus Tislelizumab |
| Non small cell lung carcinoma, small cell lung carcinoma | Experimental | Drug: IMM01, Drug: TislelizumabDose expansion cohort with IMM01 plus Tislelizumab |
| Hepatocellular carcinoma | Experimental | Drug: IMM01, Drug: TislelizumabDose expansion cohort with IMM01 plus Tislelizumab |
| Other solid tumors | Experimental | Drug: IMM01, Drug: TislelizumabDose expansion cohort with IMM01 plus Tislelizumab |
| Classic hodgkin lymphoma | Experimental | Drug: IMM01, Drug: TislelizumabDose expansion cohort with IMM01 plus Tislelizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old, male or female
- Life expectancy≥12 weeks;
- Phase 1b: Patients with advanced solid tumors diagnosed by histology or cytology, who have been failure to previous standard treatments; Phase 2: Patients with HNSCC, NPC, OC, NSCLC, SCLC, HCC, cHL and other solid tumors diagnosed by histology or cytology, who have been failure to first-line standard treatment (including PD-1/L1) at least;
- ECOG PS of 0 or 1;
- Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation.
Key exclusion criteria (11 listed)
- Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein;
- Patients with symptomatic or progressive central nervous system (CNS) metastasis;
- Uncontrolled hypertension, pulmonary hypertension or unstable angina, myocardial infarction within 6 months prior to administration; a history of chronic heart failure (NYHA G3/4); severe arrhythmia;
- A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration;
- A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency;
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 |
|---|---|---|
| IMM01Also: SIRPα FcIMM01 (1.0, 1.5, 2.0 mg/kg) QW IV in the dose escalation part. IMM01 (dose determined in the dose escalation part) QW IV in the dose expansion part. | Drug | Classic hodgkin lymphoma, Dose Escalation Part, Head and neck squamous cell carcinoma, nasopharyngeal carcinoma, Hepatocellular carcinoma, Non small cell lung carcinoma, small cell lung carcinoma, Other solid tumors, Ovarian carcinoma |
| TislelizumabTislelizumab 200mg Q3W IV | Drug | Classic hodgkin lymphoma, Dose Escalation Part, Head and neck squamous cell carcinoma, nasopharyngeal carcinoma, Hepatocellular carcinoma, Non small cell lung carcinoma, small cell lung carcinoma, Other solid tumors, Ovarian carcinoma |
Primary outcome
Dose-limiting toxicity in dose escalation part
Time frame: DLT observation 21 days
MTD/RP2D in dose escalation part
Time frame: DLT observation 21 days
ORR in dose expansion part
Time frame: up to 12 months
8 secondary outcomes
TRAEs
Time frame: up to 12 months
PFS
Time frame: up to 12 months
DOR
Time frame: up to 12 months
DCR
Time frame: up to 12 months
Cmax
Time frame: up to 12 months
T1/2
Time frame: up to 12 months
AUC
Time frame: up to 12 months
ADA
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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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. This study is not recruiting at the moment.
5 sites 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 IMM01 and Tislelizumab in people with Solid Tumor and Classic Hodgkin Lymphoma, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 5 sites 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Zong (86-21-38016387, zhenzhen.zong@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity in dose escalation part (time frame: DLT observation 21 days). 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 27 Apr 2023.