A Study of IBI310 for the Treatment of Patients With Advanced Solid Tumors.

NCT03545971 | Completed Phase 1

• 1 other identifier: CIBI310A101
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity and efficacy of single agent of IBI310, and in combination of sintilimab, in patients with advanced solid tumors(Ia) and advanced melanoma(Ib).

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• AEs

  Number of patients with treatment-related adverse events (AEs)

  up to 24 months after randomization

Secondary Outcomes (4)

• Pharmacokinetics：Cmax

  up to 24 months after randomization

• pharmacodynamics:lipid parameters

  up to 24 months after randomization

• ADA

  up to 24 months after randomization

• Pharmacokinetics：AUC

  up to 24 months after randomization

Study Arms (8)

Ia Cohort A

EXPERIMENTAL

Low-dose group:Participants will receive IBI310 0.3mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity.

Drug: IBI310

Ia Cohort B

EXPERIMENTAL

Middle-dose group:Participants will receive IBI310 1.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity

Drug: IBI310

Ia Cohort C

EXPERIMENTAL

Middle-dose group:Participants will receive IBI310 2.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity

Drug: IBI310

Ia Cohort D

EXPERIMENTAL

High-dose group:Participants will receive IBI310 3.0mg/kg intravenous every 3 weeks,after 4 cycle, if the patient benefits it will be continued until disease progression or unacceptable toxicity

Drug: IBI310

Ib Cohort A

EXPERIMENTAL

3 subjects, low-dose group:Participants will receive IBI310 1.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

Drug: IBI310; Drug: Sintilimab

Ib Cohort A2

EXPERIMENTAL

low-dose group:Participants will receive IBI310 1.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

Drug: IBI310; Drug: Sintilimab

Ib Cohort B

EXPERIMENTAL

3 subjects, low-dose group:Participants will receive IBI310 2.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

Drug: IBI310; Drug: Sintilimab

Ib Cohort B2

EXPERIMENTAL

low-dose group:Participants will receive IBI310 2.0mg/kg in Combination with Sintilimab 200mg intravenous every 3 weeks. After 4 cycles, Sintilimab alone 200mg intravenous every 3 weeks, until disease progression, lost follow-up visit, death , unacceptable toxicity, withdrawn of ICF, another other reason for end of treatment. Maximum treatment duration is 2 years.

Drug: IBI310; Drug: Sintilimab

Interventions

IBI310 DRUG

IBI310 is anti CTLA-4 antibody

Also known as: CTLA-4

Ia Cohort A; Ia Cohort B; Ia Cohort C; Ia Cohort D; Ib Cohort A; Ib Cohort A2; Ib Cohort B; Ib Cohort B2

Sintilimab DRUG

PD-1 monoclonal antibody

Ib Cohort A; Ib Cohort A2; Ib Cohort B; Ib Cohort B2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with locally advanced, recurrent or metastatic solid tumors who failed standard treatment(applicable to the Ia period).
• Patients with advanced, recurrent or metastatic melanoma confirmed by cytology or histology (applicable to the Ib period).
• Signed written informed consent form and willing and able to comply with scheduled visits and other requirements of the study.
• ≥18，and ≤70 years.
• Life expectancy of at least 12 weeks.
• At least 1 measurable lesion per RECIST v1.1(long axis\>15mm or short axis\>10mm)
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1.
• Patients of reproductive potential must be willing to use adequate contraception during the course of the study and through 6 months after the last dose of study medication.
• Adequate organ and bone marrow function.

You may not qualify if:

• Prior exposure to any anti-CTLA-4, anti-PD-1 or anti-PD-L1/L2 antibody.
• Received any investigational agent within 4 weeks of the first dose of study medication.
• Received last dose of anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, tumor immunotherapy or arterial embolization) within 4 weeks of the first dose of study medication.
• Received treatment with corticosteroids (\>10mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks before the first dose of study medication. Nasal spray, inhalation, or other ways of topical corticosteroids or physiological doses of systemic corticosteroids are not included.
• Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
• Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years (Patients with vitiligo, psoriasis, alopecia or Grave's disease, hypothyroidism requiring hormone replacement, or type I diabetes mellitus only requiring insulin replacement, but not required systemic treatment in the last 2 years, are permitted to enroll)
• Known primary immunodeficiency
• Active tuberculosis
• Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation
• Known allergy or hypersensitivity to any other monoclonal antibodies or IBI310 and/or any components used in their preparation.
• Known acute or chronic active hepatitis B (HBV DNA positive and HBV DNA copies ≥1×103/ml or ≥200IU/ml) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection. Patients with HCV antibody positive but HCV RNA negative are permitted to enroll.
• Patients with a history of interstitial lung disease
• Uncontrolled third space effusion, eg. ascites or pleural effusion cannot be drained or controlled.
• Women who are pregnant or nursing.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Location

MeSH Terms

Interventions

CTLA-4 Antigen; sintilimab

Intervention Hierarchy (Ancestors)

Immune Checkpoint Proteins; Proteins; Amino Acids, Peptides, and Proteins; Costimulatory and Inhibitory T-Cell Receptors; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins; Antigens, Differentiation, T-Lymphocyte; Antigens, Differentiation; Antigens, Surface; Antigens; Biological Factors; Biomarkers

Study Design

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

Study Record Dates

• First Submitted: May 10, 2018
• First Posted: June 6, 2018
• Study Start: September 25, 2018
• Primary Completion: September 10, 2021
• Study Completion: August 9, 2022
• Last Updated: February 28, 2023

Record last verified: 2023-02

Locations

CN (1)