IBI308 in Subjects With Advanced/Metastatic Solid Malignancies

NCT03568539 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CIBI308A102
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 7

Brief Summary

The study is to evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies. Patients will be recruited for 2 cohorts: • Cohort 1: Advanced/metastatic cancers with TMB\>10 mutations per megabase (mut/Mb). This enrollment of this cohort has been stopped per sponsor's communication with the sites. For patients who have already enrolled in this cohort, treatment and monitoring will be conducted as stipulated by the protocol. The patients will remain on study until disease progression or intolerable toxicity, death, withdrawal of consent, or end of study, whichever occurs first. Cohort 2: Advanced/metastatic endometrial cancer (N=40)

Conditions

Advanced/Metastatic Solid Malignancies

Keywords

Advanced/metastatic solid malignancies, TMB high

Outcome Measures

Primary Outcomes (1)

• Overall Response Rate (Confirmed)

  To evaluate preliminary anti-tumor activity (overall response rate, ORR) of IBI308 monotherapy in subjects with advanced/metastatic solid malignancies. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

  29 months

Secondary Outcomes (6)

• Progression-free Survival

  2 years

• Duration of Response

  2 years

• Overall Survival

  2 years

• Number of Participants With Detectable Anti- Drug Antibodies.

  2 years

• Area Under the Curve (AUC [0-504h])

  0-504h

Study Arms (1)

IBI308

EXPERIMENTAL

Drug: IBI308

Interventions

IBI308 DRUG

IBI308 200mg IV infusion, every 3 weeks.

IBI308

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures.
• Subjects (males and females) of childbearing potential should be willing to use reliable contraception methods that are deemed effective by the investigator from visit 1 through 90 days following the last dose of study drug. Postmenopausal women must have been amenorrhea for at least 12 months to be considered of non-childbearing potential.
• Male or female subjects ≥18 years
• At least one measurable lesion (per RECIST version 1.1)
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1.
• Subjects with life expectancy of ≥ 3 month
• If subject received anti-tumor therapy:
• Generalized radiation therapy must have been completed 3 weeks prior to enrollment, or local radiotherapy or radiation therapy for bone metastases for 2 weeks prior to enrollment. Treatment with radiopharmaceuticals must have been completed 8 weeks prior to enrollment.
• Previous chemotherapy, biotherapy (tumor vaccines, cytokines, or growth factors that control cancer), tyrosine kinase inhibitors, or approved targeting and other treatments should have completed at least 3 weeks prior to the first administered dose in this study;
• Subjects must have adequate organ function (liver, kidney function and hematopoietic function tests) prior IBI308 administration
• Absolute neutrophil count (ANC) ≥1.5 x10\^9/L
• Platelet count ≥ 100 x 10\^9/L
• Hemoglobin ≥ 9 g / dL (whole blood or component transfusion within 7 days before 1st dose of study drug is prohibited)
• Renal function tests: serum creatinine ≤1.5 ×upper limit of normal range (ULN) or an estimated glomerular filtration rate (eGFR) ≥ 50 mL/min/1.73 m2
• Liver function tests alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3 x ULN, for patients with known liver cancer or liver metastases, AST and ALT ≤ 5 x ULN

You may not qualify if:

• Legal incapacity or limited legal capacity.
• Pregnancy, lactation, breastfeeding.
• Concurrent anticancer treatment (e.g., cytoreductive therapy or cytokine therapy except for erythropoietin) or use of other investigational product within 28 days before start of trial treatment; major surgery within 28 days before start of trial treatment (excluding prior diagnostic biopsy.
• Note: Small molecule or antibody targeted therapy \< 3 weeks from start of trial treatment will be excluded.
• Received a biologic (G-CSF, GM-CSF) within 14 days prior to the first dose of study drug.
• Vaccination within 4 weeks of first dose of IBI308 and while on study except for administration of inactivated vaccines (e.g., inactivated influenza vaccines)
• Failure to recover from adverse events from the most recent anti-tumor treatment to CTCAE ≤ grade 1 or baseline with the exception of alopecia;
• Active autoimmune disease requiring systemic treatment within the past 1 year or a documented history of clinically severe autoimmune disease or a syndrome that requires systemic steroids or immunosuppressive agents during the conduct of this study. Exceptions: - Vitiligo, eczema, psoriasis (\<10% of body surface area (BSA) of skin eruption or systemic involvement) or resolved childhood asthma/atopy, autoimmune hypothyroidism stable on hormone replacement.
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
• Acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
• History of primary immunodeficiency, stem cell or organ transplant, or previous clinical diagnosis of tuberculosis.
• Subject who have had severe infection within 4 weeks or signs and symptoms of any active infection within 2 weeks prior to the first dose administration.
• Known allergies, hypersensitivity, or intolerance to protein-based therapies or with a history of any significant drug allergy (e.g., anaphylaxis, hepatotoxicity, immune-mediated thrombocytopenia or anemia
• Subjects who experienced (irAE) grade≥3 immunotherapy-related adverse events. Subjects with CNS metastasis unless they are asymptomatic or adequately treated with radiotherapy and/or surgery and subjects are neurologically stable with minimal residual symptoms/signs 14 days prior to dosing.
• Patients who require high dose of systemic corticosteroids (\>10 mg/day prednisone or equivalents) for at least 2 weeks prior to treatment are not eligible.

Sponsors & Collaborators

• Innovent Biologics (Suzhou) Co. Ltd.: lead

Study Sites (7)

UC Irvine Medical Center

Orange, California, 92868, United States

Location

Northside Hospital, Inc

Atlanta, Georgia, 30342, United States

Location

Henry Ford Medical Center

Detroit, Michigan, 48202, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89169, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Mary Crowley Cancer Research

Dallas, Texas, 75230, United States

Location

MeSH Terms

Interventions

sintilimab

Results Point of Contact

• Title: YiBo
• Organization: Innovent Biologics (Suzhou) Co., Ltd.

jessica.yi@innoventbio.com

+8613382419112

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: June 26, 2018
• Study Start: June 27, 2018
• Primary Completion: November 9, 2020
• Study Completion: December 7, 2020
• Last Updated: June 1, 2021
• Results First Posted: June 1, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)