Evaluating IBI334 for advanced solid tumors

A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors

This study is testing a new drug called IBI334 to see how safe it is and what the best dose is for people with advanced solid tumors that haven't responded to other treatments.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 128 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. (industry)
• Locations: 1 site (Waratah, New South Wales)
• Trial ID: NCT05774873 on ClinicalTrials.gov

What this trial studies

This study aims to assess the safety and tolerability of IBI334 in patients with unresectable, locally advanced, or metastatic solid tumors. It will determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D) of IBI334 through a phased approach. Participants will include those whose tumors are refractory to standard treatments or for which no standard treatment is available. The study will involve various formulations of IBI334 to identify the most effective dosage.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with specific types of unresectable solid tumors that have not responded to standard therapies.

Not a fit: Patients with resectable tumors or those who have not exhausted standard treatment options may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that currently have limited therapeutic alternatives.

How similar studies have performed: While this approach is focused on a specific drug and patient population, similar studies have shown promise in treating advanced solid tumors with novel therapies.

Eligibility criteria

Inclusion Criteria：

1. Male or female subjects ≥ 18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
3. Anticipated life expectancy of ≥ 12 weeks;
4. Adequate bone marrow and organ function;

   Criteria for dose escalation phase only:
5. 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 (mainly focused on non-small-cell lung cancer, head and neck squamous cell carcinoma and RAS-wildtype colorectal cancer);
6. At least 1 evaluable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;

   Criteria for dose expansion phase only:
7. Has a documented (histologically- or cytologically-proven), unresectable, locally advanced or metastatic non-small-cell lung cancer, head and neck squamous cell carcinoma or RAS-wildtype colorectal cancer that is refractory to or intolerable with standard treatment, or for which no standard treatment is available;
8. At least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

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. Received live vaccines within 4 weeks prior to first dose of the study drug or plan on receiving any live vaccine during the study;
3. Received total pelvic radiotherapy;
4. Pyloric obstruction and/or persistent recurrent vomiting (≥ 3 times in 24 hours);
5. Uncontrolled diseases;
6. History of endotracheal or gastrointestinal stent implantation;
7. Multiple concurrent malignant tumors within 5 years (except non-melanoma skin cancer, carcinoma in situ or non-invasive tumor that were cured);
8. Women who are pregnant, have positive results in pregnancy test or are lactating;
9. Not eligible to participate in this study at the discretion of the investigator.

Where this trial is running

Waratah, New South Wales

• Westmead Hospital — Waratah, New South Wales, Australia (RECRUITING)

Study contacts

• Study coordinator: Emilia Tan

Conditions: Solid Tumors