First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors

NCT03758001 | Completed Phase 1

• 1 other identifier: CIBI101A101
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Incicende of Adverse Events (AEs)

  Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE), discontinuation of study drug due to AE, dose-limiting toxicity (DLT) assessed by CTCAE v5.0.

  2 years

Secondary Outcomes (15)

• Overall response rate (ORR)

  2 years

• Time to response (TTR)

  2 years

• Duration of response (DOR)

  2 years

• Progression free survival (PFS)

  2 years

• Area Under Curve (AUC)last and AUC0-inf

  2 years

Study Arms (2)

IBI101

EXPERIMENTAL

IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested.

Drug: IBI101

IBI101 in combination with Sintilimab

EXPERIMENTAL

IBI101 and Sintilimab will be administrated intravenously. 3+3 dose escalation design will be used with 4 dose levels of IBI101 being tested. Two dose levels of IBI101 in combination with Sintilimab will be expanded to 10 patients each.

Drug: IBI101; Drug: Sintilimab

Interventions

IBI101 DRUG

0.01 mg/kg; 0.1 mg/kg; 0.3 mg/kg; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg; 15 mg/kg iv infusion day 1 of every 21 days

IBI101

Sintilimab DRUG

200mg iv infusion day 1 of every 21 days

Also known as: IBI308

IBI101 in combination with Sintilimab

Eligibility Criteria

• Age: 18 Years - 75 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 have failed standard treatment
• to 75 years old
• Life expectancy ≥ 12 weeks
• At least 1 measurable lesion
• ECOG PS score 0 or 1
• Adequate organ and bone marrow function

You may not qualify if:

• Previous exposure to anti-OX40, anti-PD-1, anti-PD-L1, anti-PD-L2 antibody or other immune checkpoint inhibitors
• Exposure to any other investigational drug in the 4 weeks prior to 1st dose of investigational drug
• Exposure to anti-tumor agents in the 3 weeks prior to 1st dose of investigational drug
• Exposure to immunosuppressant in the 3 weeks prior to 1st dose of investigational drug
• Major surgery in the 4 weeks prior to 1st dose of investigational drug
• Gy radiation in the chest in the 6 months prior to 1st dose of investigational drug
• History of autoimmune disease
• Symptomatic CNS metastasis

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Interventions

sintilimab

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: November 1, 2018
• First Posted: November 29, 2018
• Study Start: February 13, 2019
• Primary Completion: February 16, 2023
• Study Completion: February 16, 2023
• Last Updated: February 22, 2023

Record last verified: 2023-02

Locations

CN (1)