NCT05833984

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
309

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2022

Typical duration for phase_1

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 27, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2024

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 20, 2024

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

1.7 years

First QC Date

March 27, 2023

Last Update Submit

April 18, 2023

Conditions

Solid TumorClassic Hodgkin Lymphoma

Outcome Measures

Primary Outcomes (3)

  • Dose-limiting toxicity in dose escalation part

    DLT observation 21 days

  • MTD/RP2D in dose escalation part

    DLT observation 21 days

  • ORR in dose expansion part

    up to 12 months

Secondary Outcomes (8)

  • TRAEs

    up to 12 months

  • PFS

    up to 12 months

  • DOR

    up to 12 months

  • DCR

    up to 12 months

  • Cmax

    up to 12 months

  • +3 more secondary outcomes

Study Arms (7)

Dose Escalation Part

EXPERIMENTAL

Mutiple dose level cohorts in the dose escalation part

Drug: IMM01Drug: Tislelizumab

Head and neck squamous cell carcinoma, nasopharyngeal carcinoma

EXPERIMENTAL

Dose expansion cohort with IMM01 plus Tislelizumab

Drug: IMM01Drug: Tislelizumab

Ovarian carcinoma

EXPERIMENTAL

Dose expansion cohort with IMM01 plus Tislelizumab

Drug: IMM01Drug: Tislelizumab

Non small cell lung carcinoma, small cell lung carcinoma

EXPERIMENTAL

Dose expansion cohort with IMM01 plus Tislelizumab

Drug: IMM01Drug: Tislelizumab

Hepatocellular carcinoma

EXPERIMENTAL

Dose expansion cohort with IMM01 plus Tislelizumab

Drug: IMM01Drug: Tislelizumab

Other solid tumors

EXPERIMENTAL

Dose expansion cohort with IMM01 plus Tislelizumab

Drug: IMM01Drug: Tislelizumab

Classic hodgkin lymphoma

EXPERIMENTAL

Dose expansion cohort with IMM01 plus Tislelizumab

Drug: IMM01Drug: Tislelizumab

Interventions

IMM01DRUG

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.

Also known as: SIRPα Fc
Classic hodgkin lymphomaDose Escalation PartHead and neck squamous cell carcinoma, nasopharyngeal carcinomaHepatocellular carcinomaNon small cell lung carcinoma, small cell lung carcinomaOther solid tumorsOvarian carcinoma
TislelizumabDRUG

Tislelizumab 200mg Q3W IV

Classic hodgkin lymphomaDose Escalation PartHead and neck squamous cell carcinoma, nasopharyngeal carcinomaHepatocellular carcinomaNon small cell lung carcinoma, small cell lung carcinomaOther solid tumorsOvarian carcinoma

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);

You may not qualify if:

  • 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;
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Zhejiang Cancer Hospital

Hangzhou, China

RECRUITING

Shandong Provincial Institute of Cancer Prevention and Treatment

Jinan, China

RECRUITING

The Third Affiliated Hospital of Qiqihar Medical University

Qiqihar, China

RECRUITING

Shanghai Chest Hospital

Shanghai, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

tislelizumab

Central Study Contacts

Zhenzhen Zong

CONTACT

86-21-38016387zhenzhen.zong@immuneonco.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 27, 2023

Study Start

May 17, 2022

Primary Completion

February 7, 2024

Study Completion

November 20, 2024

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations

CN(5)