NCT06349408 IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors
| NCT ID | NCT06349408 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Innovent Biologics (Suzhou) Co. Ltd. |
| Condition | Locally Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 250 participants in total. It began in 2025-01-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. -
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06349408 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06349408 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06349408 currently recruiting?
Yes, NCT06349408 is actively recruiting participants. Contact the research team at sujie.zhang@innoventbio.com for enrollment information.
Where is the NCT06349408 trial being conducted?
This trial is being conducted at Wollongong, Australia, Adelaide, Australia, Beijing, China, Shanghai, China and 1 additional location.
Who is sponsoring the NCT06349408 clinical trial?
NCT06349408 is sponsored by Innovent Biologics (Suzhou) Co. Ltd.. The trial plans to enroll 250 participants.