A Multicentre,Study of IBI133 in Subjects WithUnresectable, Locally Advanced or Metastatic SolidTumours

Innovent Biologics (Suzhou) Co. Ltd.19 enrolled

Overview

This is a multicentre, open-label, first-in-human, phase 1/2 study of IBI133 in subjects with unresectable, locally advanced or metastatic solid tumours. Phase 1 section includes three parts, IBI133 dose escalation part, and IBI133 monotherapy dose expansion part. The objective of phase 1 section is to identify MTD/recommended dose for expansion (RDE) of IBI133 monotherapy . The objective of phase 2 section is to further explore efficacy, safety and tolerability of IBI133 monotherapy at RDE in specified tumour population. The treatment cycle of the study is defined as every 3 weeks (21 days).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Locally Advanced Unresectable or Metastatic Solid Tumors

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subjects with the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. Male or female subjects ≥ 18 years old; 3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1; 4. Anticipated life expectancy of ≥ 12 weeks; 5. Adequate bone marrow and organ function. 6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumour that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; Exclusion Criteria: 1. Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study; 2. Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate. 3. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).

Outcomes

Primary Outcomes

Dose limiting toxicities (DLTs)

DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD)and /or recommended phase 2 dose (RP2D)

Time frame: 21 days after the first dose of IBI133

Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)

Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0

Time frame: Up to 90 days after the last administration

Secondary Outcomes

maximum concentration (Cmax)

PK parameters maximum concentration(Cmax)of IBI133,total antibody,can will be determined

Time frame: Up to 2 years

area under the curve (AUC)

PK parameters clearance rate of IBI133,total antibody,exate can will be determined

Time frame: Up to 2 years

clearance rate(CL)

PK parameters clearance rateof IBI133,total antibody,exate can will be determined

Time frame: Up to 2 years

half-life (T1/2)

PK parameters half-life of IBI133,total antibody,exate can will be determined

Time frame: Up to 2 years

anti-drug antibody (ADA)

the incidence and characterization of ADA OF IBI133 will be determined

Time frame: Up to 2 years

Preliminary efficacy including objective response rate (ORR)

ORR is defined as the proportion of subjects with a CR or PR. Number and percentage of subjects with CR or PR will be summarized.