A Phase I Study of IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
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Study 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.
Dose escalation: To assess the safety and tolerability of IBI3001. The maximum tolerated dose or phase II recommended dose of the IBI3001 is determined. To evaluate the pharmacokinetic (PK) profile of IBI3001, anti-epidermal growth factor receptor (EGFR)/B7 homologous protein 3 (B7H3) total antibody and exitechan. Evaluate the immunogenicity of the IBI3001. To evaluate the preliminary efficacy of IBI3001. To evaluate the relationship between biomarkers and IBI3001 efficacy. Dose expansion: To assess the preliminary antitumor activity of the IBI3001. To assess the safety and tolerability of IBI3001. The antitumor activity of IBI3001 was assessed using other efficacy indicators. To evaluate the PK characteristics of the IBI3001. Evaluate the immunogenicity of the IBI3001. To evaluate the relationship between biomarkers and IBI3001 efficacy
- 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.
- 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. -
- 1Currently involved in another interventional clinical study, excluding observational (non-interventional) clinical studies or those in the survival follow-up phase of interventional studies.2Patients who have previously received systemic anti-tumor therapy with antibody-drug conjugates containing ixotecan derivatives, and whose disease has progressed or who are intolerant to such treatment.3Other systemic anti-tumor treatments received during the study period, excluding palliative radiotherapy for the purpose of relieving symptoms (e.g., pain) (provided that it does not affect tumor assessment throughout the study).4Subjects who have used a potent cytochrome P450 3A4 (CYP3A4) inhibitor within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose of the study drug must also be excluded.5Those who have received a live vaccine within 4 weeks prior to the first dose of the investigational drug or who plan to receive any live vaccine during the study period.6The patient had prior antitumor therapy that had not recovered to grade 1 (excluding alopecia, asthenia, hyperpigmentation and other conditions that, in the investigator’s opinion, posed no safety risk) within 4 weeks prior to the first administration of the study drug.7Patients who have undergone or plan to undergo major surgery (craniotomy, thoracotomy, or laparotomy, or other procedures as defined by the investigator, excluding biopsy) within 4 weeks prior to or during the study period, or who have severe unhealed wounds, injuries, ulcers, etc.8Pyloric obstruction and/or persistent recurrent vomiting (≥3 times within 24 hours)9Patients who experienced gastrointestinal perforation and/or fistula within 6 months prior to the first administration of the study drug, and whose condition did not improve after surgical treatment.10Symptomatic central nervous system (CNS) metastases are known.
Clinical Study Information for Healthcare Providers
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