A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers

Phase 1

Completed

• Conditions: Advanced Malignant Tumors Lymphomas
• Interventions: Biological: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection

• Registration Number: NCT04338659
• Lead Sponsor: Innovent Biologics (Suzhou) Co. Ltd.

Brief Summary

This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.

Detailed Description

A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors

Study Timeline

• Study First Submitted: 2020-03-24
• Study First Submitted QC: 2020-04-07
• Study First Posted: 2020-04-08
• Study Start: 2021-01-14
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-06
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

1. Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit.
2. At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
3. Male or female subject > 18 years old.
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
5. Must have adequate organ function including the following.
6. Subjects with life expectancy ≥ 12 weeks.
7. Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period.
8. Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.

Exclusion Criteria

1. Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
2. Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
3. Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
4. Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy.
5. Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug.
6. Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes.
7. Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue
8. Subjects who received whole pelvic radiotherapy prior to the enrollment.
9. Subjects with known cerebrospinal metastases and other known central nervous system metastases.
10. Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy).
11. Known history of primary immunodeficiency.
12. Known history of active pulmonary tuberculosis.
13. Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
14. Known history of hypersensitivity to any components of the IBI322 injection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Dose Escalation of IBI322	IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection	Participants will receive escalating dose levels of IBI322 to determine maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of IBI322

Primary Outcome Measures

Name	Time	Method
Dose Limiting Toxicity (DLT)	.Day 1 - Day 21
Treatment-related Adverse Events (TRAEs)	Day 1 - 90 days after last administration

Secondary Outcome Measures

Name	Time	Method
PK parameters	Up to 90 days post last dose	The half-life (t1/2)
Positive rate of ADA and Nab	Up to 90 days post last dose
Positive rate of Circulating Immune Complex	Through study completion, an average of 1 year

Trial Locations

Locations (4)

The University of Kansas Cancer Center; 🇺🇸 Westwood, Kansas, United States

University Of Mississippi Medical Center; 🇺🇸 Jackson, Mississippi, United States

The University of Texas MD Anderson Cancer Center - Investigational Cancer Therapies; 🇺🇸 Houston, Texas, United States

The Angeles Clinic And Research Institute; 🇺🇸 Los Angeles, California, United States