Clinical trial NCT05991349: A Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors
Official title: A Phase 1/2 Study of IBI129 in Subjects with Unresectable, Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumor
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 1/2 multicenter, first-in-human study of IBI129. It includes a phase 1 dose escalation and expansion section to identify MTD/RP2D of IBI129, plan to enroll 22\~180 subjects, and a phase 2 to explore efficacy, safety and tolerability of IBI129 at RP2D in specified types of solid tumor. Approximately 182 evaluable subjects will be enrolled for phase 2


Eligibility criteria: 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. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.;
3. Male or female subjects ≥ 18 years old;
4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
5. Anticipated life expectancy of ≥ 12 weeks;
6. Adequate bone marrow and organ function

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. Received previous anti-tumor therapy within 4 weeks or 5 half-lives of the anti-tumor regimens before the first administration of study drug, whichever is shorter.
3. Progressed refractory to an antibody drug conjugate that consists of an exatecan derivative that is a topoisomerase I inhibitor.
4. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also do not have impact on tumor assessment throughout the study;
5. Known symptomatic central nervous system (CNS) metastases.

Primary outcomes:
measure: Number of subjects with adverse events
timeFrame: 24 months
measure: Number of subjects with clinically significant changes in physical examination results
timeFrame: 24 months
measure: Number of subjects with clinically significant changes in vital signs
timeFrame: 24 months
measure: MTD or RP2D of IBI129
timeFrame: 12 months
Secondary outcomes:
measure: Plasma concentration (Cmax) of IBI129
timeFrame: 12 months
measure: Area under the curve (AUC) of IBI129
timeFrame: 12 months
measure: Time to maximum concentration (Tmax) of IBI129
timeFrame: 12 months
measure: Clearance (CL) of IBI129
timeFrame: 12 months
measure: Volume of distribution (V) of IBI129
timeFrame: 12 months
measure: Half-life (T1/2) of IBI129
timeFrame: 12 months
measure: Immunogenicity of IBI129
timeFrame: 12 months
measure: Objective response rate (ORR)
timeFrame: 24 months
measure: Duration of response (DoR)
timeFrame: 24 months
measure: Disease control rate (DCR)
timeFrame: 24 months
measure: Time to response (TTR)
timeFrame: 24 months
measure: Progression free survival (PFS)
timeFrame: 24 months
measure: Overall survival (OS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse
state: New South Wales
city: Kogarah
country: Australia
facility: St George private Hospital
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital
state: New South Wales
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hubei
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Cancer Hospital
state: Shandong
city: Tianjin
country: China
facility: Tianjin Medical university cancer institute & Hospital
state: Tianjin
Study officials:
References: