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Recruiting NCT06349408

IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Phase I Interventional Locally Advanced Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IBI3001.
Who it may be relevant to
Registry conditions: Locally Advanced Solid Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Australia, China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase 1 Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors

Overview

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.

Interventions

  • Drug IBI3001
    The provisional dose levels are planned to be evaluated, but it is possible for additional and/or intermediate dose levels to be added during the study. IBI3001 is proposed to be administered by intravenous infusion (IV)

Primary outcome measures

  • Number of subjects with adverse events [Time frame: 24 months]
  • Number of subjects with clinically significant changes in physical examination results [Time frame: 24 months]
  • Number of subjects with clinically significant changes in vital signs [Time frame: 24 months]
  • MTD or RP2D of IBI3001 Number of subjects with dose-limiting toxicities (DLTs) [Time frame: 24 months]
Secondary outcome measures (12)
  • Plasma concentration (Cmax) of IBI3001 [Time frame: 24 months]
  • Area under the curve (AUC) of IBI3001 [Time frame: 24 months]
  • Time to maximum concentration (Tmax) of IBI3001 [Time frame: 24 months]
  • Clearance (CL) of IBI3001 [Time frame: 24 months]
  • Volume of distribution (V) of IBI3001 [Time frame: 24 months]
  • Half-life (T1/2) of IBI3001 [Time frame: 24 months]
  • Immunogenicity of IBI3001 [Time frame: 24 months]
  • Objective response rate (ORR) [Time frame: 24 months]
  • Duration of response (DoR) [Time frame: 24 months]
  • Disease control rate (DCR) [Time frame: 24 months]
  • Time to response (TTR) [Time frame: 24 months]
  • Progression free survival (PFS) [Time frame: 24 months]

Eligibility criteria

Inclusion criteria

  • Male or female participants ≥ 18 years old;
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
  • Has an anticipated life expectancy of ≥ 12 weeks;
  • Adequate bone marrow and organ function:
  • 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.
  • 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.

Exclusion criteria

  • 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;
  • 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;
  • Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
  • Gastrointestinal perforation and/or fistula within 6 months prior to first administration of the study drug, and not recovered after surgical treatment;
  • Known symptomatic central nervous system (CNS) metastases.
  • History of pneumonia requiring corticosteroids therapy, or history of clinically significant lung diseases; Uncontrolled diseases;
  • History of endotracheal or gastrointestinal stent implantation;
  • Ascites, pleural effusion, or pericardial effusion with symptoms and requiring intervention;
  • Esophageal or gastric varices requiring immediate intervention;
  • Not eligible to participate in this study at the discretion of the investigator;
  • Do not have adequate treatment washout period before study drug administration. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 3 centers
  • Chinese PLA General Hospital — Beijing
  • Shanghai East Hospital — Shanghai
  • The First Affiliated Hospital of zhejiang University School of Medicine — Hangzhou
Australia · 2 centers
  • Wollongong Public — Wollongong
  • Cancer Research SA — Adelaide

Identifiers

NCT: NCT06349408 · CIBI3001A101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗