Clinical trial NCT06349408: IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Official title: A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Locally Advanced Solid Tumor
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-04-05
Enrollment: 250
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 multicenter, multi-regional, open-label, first-in-human study of IBI3001 in participants with unresectable, locally advanced or metastatic solid tumors. The purpose of this study is to identify the MTD/RP2D of IBI3001, and to explore the preliminary efficacy of IBI3001.


Eligibility criteria: Key Inclusion Criteria:

1. Male or female participants ≥ 18 years old;
2. Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Has an anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function:
5. At least 1 evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1. for dose escalation , and 1 measurable lesion for dose expansion.
6. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available; participants who refuse standard therapy, or are able to suspend standard therapy without major risks.

Key Exclusion Criteria:

1. Progressed or refractory to an ADC that consists of an Exatecan derivative that is a topoisomerase I inhibitor or intolerable with an ADC that consists of Exatecan;
2. Plan to receive other antitumor therapy during the study excluding palliative radiotherapy for the purpose of symptom (like pain) relief that must also not have an impact on tumor assessment throughout the study;
3. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
4. Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
5. Known symptomatic central nervous system (CNS) metastases.
6. History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
7. History of endotracheal or gastrointestinal stent implantation;
8. Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
9. Esophageal or gastric varices requiring immediate intervention;
10. Not eligible to participate in this study at the discretion of the investigator;
11. Do not have adequate treatment washout period before study drug administration. -

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 IBI3001 Number of subjects with dose-limiting toxicities (DLTs)
timeFrame: 24 months
Secondary outcomes:
measure: Plasma concentration (Cmax) of IBI3001
timeFrame: 24 months
measure: Area under the curve (AUC) of IBI3001
timeFrame: 24 months
measure: Time to maximum concentration (Tmax) of IBI3001
timeFrame: 24 months
measure: Clearance (CL) of IBI3001
timeFrame: 24 months
measure: Volume of distribution (V) of IBI3001
timeFrame: 24 months
measure: Half-life (T1/2) of IBI3001
timeFrame: 24 months
measure: Immunogenicity of IBI3001
timeFrame: 24 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: Wollongong
country: Australia
facility: Wollongong Public
state: New South Wales
city: Adelaide
country: Australia
facility: Cancer Research SA
state: South Australia
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Shanghai
country: China
facility: Shanghai East Hospital
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital of zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: