Clinical trial · Interventional
A Multicentre,Study of IBI133 in Subjects WithUnresectable, Locally Advanced or Metastatic SolidTumours
A Multicentre, Open-label, Phase 1/2 Study of IBI133 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumours
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Locally Advanced Unresectable or Metastatic Solid Tumors | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IBI133 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Open-label：IBI133 monotherapy
- interventionNames
- Biological: IBI133
Primary outcomes (2)
- measure
- Dose limiting toxicities (DLTs)
- timeFrame
- 21 days after the first dose of IBI133
- description
- DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD)and /or recommended phase 2 dose (RP2D)
- measure
- Safety: Adverse events (AEs);treatment emergent adverse event(TEAEs),serious adverse events(SAEs)
- timeFrame
- Up to 90 days after the last administration
- description
- Adverse events will be assessed by investigator(s)according to NCI-CTCAE v5.0
Secondary outcomes (10)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available