Safety and Efficacy of IMM01 Plus Tislelizumab in Patients With Advanced Solid Tumors and Lymphomas

April 18, 2023 updated by: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

309

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Hangzhou, China
        • Recruiting
        • Zhejiang Cancer Hospital
        • Contact:
        • Principal Investigator:
          • Zhengbo Song, M.D.
      • Jinan, China
        • Recruiting
        • Shandong Provincial Institute of Cancer Prevention and Treatment
        • Principal Investigator:
          • Yan Zhang, M.D.
        • Contact:
        • Principal Investigator:
          • Hui Zhu, M.D.
      • Qiqihar, China
        • Recruiting
        • The Third Affiliated Hospital of Qiqihar Medical University
        • Contact:
        • Principal Investigator:
          • Xu Tong, M.D.
      • Shanghai, China
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
        • Principal Investigator:
          • Shun Lu, Ph.D.
      • Zhengzhou, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥18 years old, male or female
  2. Life expectancy≥12 weeks;
  3. 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;
  4. ECOG PS of 0 or 1;
  5. Adequate organs function, including bone marrow, hepatic, renal, cardiac, coagulation.
  6. Adverse events associated with previous anti-tumor therapy have returned to≤ grade 1(NCI CTCAE V5.0);

Exclusion Criteria:

  1. Previous treatment with CD47 inhibitor/SIRPαinhibitor or fusion protein;
  2. Patients with symptomatic or progressive central nervous system (CNS) metastasis;
  3. 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;
  4. A history of arterial thrombosis, deep venous thrombosis and pulmonary embolism within 3 months prior to administration;
  5. A history of moderate or severe dyspnea, interstitial lung disease (ILD) or servre pneumonia, severe chronic obstructive pulmonary disease, severe pulmonary insufficiency;
  6. With other malignant tumors;
  7. Diseases that may cause gastrointestinal bleeding or perforation;
  8. Uncontrollable pleural, peritoneal or pericardial effusions;
  9. A history of immunodeficiency;
  10. A history of autoimmune diseases;
  11. Uncontrolled severe active infections.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation Part
Mutiple dose level cohorts in the dose escalation part
Drug: IMM01
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.
Other Names:
  • SIRPα Fc
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
Experimental: Head and neck squamous cell carcinoma, nasopharyngeal carcinoma
Dose expansion cohort with IMM01 plus Tislelizumab
Drug: IMM01
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.
Other Names:
  • SIRPα Fc
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
Experimental: Ovarian carcinoma
Dose expansion cohort with IMM01 plus Tislelizumab
Drug: IMM01
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.
Other Names:
  • SIRPα Fc
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
Experimental: Non small cell lung carcinoma, small cell lung carcinoma
Dose expansion cohort with IMM01 plus Tislelizumab
Drug: IMM01
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.
Other Names:
  • SIRPα Fc
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
Experimental: Hepatocellular carcinoma
Dose expansion cohort with IMM01 plus Tislelizumab
Drug: IMM01
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.
Other Names:
  • SIRPα Fc
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
Experimental: Other solid tumors
Dose expansion cohort with IMM01 plus Tislelizumab
Drug: IMM01
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.
Other Names:
  • SIRPα Fc
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV
Experimental: Classic hodgkin lymphoma
Dose expansion cohort with IMM01 plus Tislelizumab
Drug: IMM01
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.
Other Names:
  • SIRPα Fc
Drug: Tislelizumab
Tislelizumab 200mg Q3W IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose-limiting toxicity in dose escalation part
Time Frame: DLT observation 21 days
DLT observation 21 days
MTD/RP2D in dose escalation part
Time Frame: DLT observation 21 days
DLT observation 21 days
ORR in dose expansion part
Time Frame: up to 12 months
up to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
TRAEs
Time Frame: up to 12 months
up to 12 months
PFS
Time Frame: up to 12 months
up to 12 months
DOR
Time Frame: up to 12 months
up to 12 months
DCR
Time Frame: up to 12 months
up to 12 months
Cmax
Time Frame: up to 12 months
up to 12 months
T1/2
Time Frame: up to 12 months
up to 12 months
AUC
Time Frame: up to 12 months
up to 12 months
ADA
Time Frame: up to 12 months
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2022

Primary Completion (Anticipated)

February 7, 2024

Study Completion (Anticipated)

November 20, 2024

Study Registration Dates

First Submitted

March 27, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 27, 2023

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMM01-04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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