Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This study is a multicentre, open-label Phase 1/2 trial testing IBI133 in people with advanced solid tumours that cannot be surgically removed.
Phase 1 of the study includes:
-
- Dose Escalation: Testing different doses of IBI133 to find the maximum tolerated dose (MTD).
- Dose Expansion: Testing the chosen dose to confirm its safety and effectiveness.
Phase 2 of the study aims to further evaluate how well the selected dose of IBI133 works, its safety, and how well it is tolerated in specific types of tumors.
Participants receive the drug every 3 weeks (21 days).
Conditions
This trial is treating people with advanced solid tumours
Eligibility
Inclusion
Inclusion Criteria:
- 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;
- Male or female subjects ≥ 18 years old;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
- Anticipated life expectancy of ≥ 12 weeks;
- Adequate bone marrow and organ function.
- 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
Exclusion Criteria:
- Participate in any other interventional clinical research except observational (non-interventional) study or in the follow-up phase of the interventional study;
- Prior HER3 targeted treatment, including but not limited to monoclonal antibody, bispecific antibody, T cell engager, and antibody-drug conjugate.
- Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (e.g. DS-8201).
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Innovent Biologics (Suzhou) Co. Ltd.
Scientific Title
A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
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