A Phase 1 Study Evaluating the Safety, Tolerability, and Initial Efficacy of IBI188 in Advanced Malignancies

NCT03717103 | Completed Phase 1

• 1 other identifier: CIBI188A101
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, dose escalation, Phase I study to evaluate the safety, tolerability, pharmacokinetics and efficacy in patients with advanced malignancies.

Conditions

Advanced Malignancies

Outcome Measures

Primary Outcomes (1)

• Adverse events (AEs), Serious Adverse Events (SAE)Number of patients with AEs and SAEs

  Incidence, correlation with the study drug and severity of all adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs).

  24 months

Secondary Outcomes (4)

• Preliminary anti-tumor activity of IBI188 (Objective Response Rate)

  24 months

• Pharmacokinetics: Cmax

  24 months

• Pharmacokinetics: AUC

  24 months

• Immunogenicity

  24 months

Study Arms (1)

IBI188

EXPERIMENTAL

Part A : Initial dose escalation, Part B : Maintenance dose escalation

Drug: IBI188

Interventions

IBI188 DRUG

Part A: 0.1 mg/kg IV QW, 0.3 mg/kg IV QW, 1 mg/kg IV QW. Part B: 1mg/kg IV D1+3, 10, 20, 30 mg/kg IV D8 QW or 45mg/kg D8 IV Q3W.

Also known as: Letaplimab

IBI188

Eligibility Criteria

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

You may qualify if:

• Advanced solid tumors and lymphomas defined by:
• Histologically/cytologically confirmed solid tumors and lymphomas
• Solid Tumors failed from standard therapy
• Lymphoma patients who have had at least two standard treatment failures
• Subject has at least 1 measurable disease per RECIST v1.1. Lymphomas have at least one measurable lesion and 18FDG-avid lesion according to the Lugano 2014 criteria.
• Male or female subject above 18 years
• ECOG Performance Status 0 to 1
• Must have adequate organ and bone marrow function, including the following:
• Blood routine: absolute neutrophil count (ANC) ≥ 1.5 x10\^9/L; platelet count ≥ 75 x 10\^9/L; hemoglobin ≥ 10 g/dL. (For subjects with AML, WBC \< 25×10\^9/L was required , and there is no restriction for the rest in blood routine test ).
• Hepatic: total bilirubin ≤ 1.5 times of the upper limit of normal (ULN), aspartate transaminase (AST) and/or alanine aminotransferase (ALT) ≤ 2.5 X ULN (≤5 X ULN if with liver involvement). total bilirubin ≤ 3×ULN if subjects were diagnosed with Gilbert syndrome.
• Renal: serum creatinine ≤ 1.5 X ULN or estimated creatinine clearance ≥50mL/min. Urinary protein \< 2+. For subjects with urinary protein ≥2+ at baseline, a 24h urine collection should be performed with urine protein \< 1g.
• Coagulation tests INR \< 1.5, partial prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN
• Subjects with life expectancy of ≥ 12 weeks
• Female subjects of child-bearing potential or male subjects with female partners of child-bearing potential must be willing to use viable contraception method that is deemed effective by the investigator throughout the treatment period and for at least 6 months following the last dose of study drug.
• Be willing to sign the Informed Consent Form (ICF), and can follow the visit schedule and procedures defined in the protocol.

You may not qualify if:

• Previous exposure to any anti-CD47 monoclonal antibody or SIRPα antibody.
• Subjects participating in any other interventional clinical study
• Received blood transfusion, biologic G-CSF, GM-CSF, erythropoietin, thrombopoietin (TPO) or IL-11within 3 weeks prior to the first dose of study drug
• Receive the last dose of anti-tumor therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization, etc.) within 3 weeks before the first dose of the study.
• Immunosuppressive drugs were used within 7 days before the first dose of the study
• Plan to receive live attenuated vaccines within 4 weeks before the first dose treatment or during the study period.
• Has undergone major surgery (craniotomy, thoracotomy or laparotomy) or is expected to require major surgery during the first dose of the study.
• Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5.0, with exception of the residual hair loss nor fatigue
• Had received total pelvic radiotherapy before.
• Central nervous system metastases:
• Subjects with active or suspected autoimmune disease or a history of the disease in the past two years
• known history of primary immunodeficiency.
• known history of active pulmonary tuberculosis.
• known history of allograft transplantation and history of allogeneic hematopoietic stem cell transplantation.
• known to be allergic to any IBI188 preparations.

Sponsors & Collaborators

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

Study Sites (1)

Beijing Cancer Hospital

Beijing, Beijing Municipality, 100142, China

Location

Study Officials

• Song Yuqin

  Peking University Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

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: October 22, 2018
• First Posted: October 24, 2018
• Study Start: January 10, 2019
• Primary Completion: February 16, 2022
• Study Completion: February 16, 2022
• Last Updated: April 7, 2022

Record last verified: 2022-03

Locations

CN (1)