Clinical trial NCT05774873: IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Official title: A Phase I/II Study of IBI334 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Solid Tumors
Lead sponsor: Innovent Biologics (Suzhou) Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2023-03-20
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The primary objective of this study to evaluate the safety and tolerability of IBI334 and determine the maximum tolerated dose (MTD) and the recommended Phase 2 Dose (RP2D) of IBI334.


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.

Primary outcomes:
measure: Number of patients with treatment-related adverse events
timeFrame: Up to 60 days post last dose
measure: Percentage of subjects woth Dose-Limitine toxicities(DLTs)
timeFrame: Up to 28 days following first dose
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to 60 days post last dose
measure: Duration of response (DoR)
timeFrame: Up to 60 days post last dose
measure: Disease control rate (DCR)
timeFrame: Up to 60 days post last dose
measure: Time to Response (TTR)
timeFrame: Up to 60 days post last dose
measure: Progression-free survival (PFS)
timeFrame: Up to 60 days post last dose
measure: Overall survival (OS)
timeFrame: Up to 60 days post last dose
Other outcomes:
Locations:
city: Waratah
country: Australia
facility: Westmead Hospital
state: New South Wales
Study officials:
References: