What this study is
This is a first-in-human, Phase 1, multi-center, open-label study to characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary anti tumor activity of LTZ-232 as monotherapy in adult participants with unresectable or metastatic colorectal cancer and other solid tumors failing standard therapies.
What's being tested
- LTZ-232
Intervention · DRUG
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.
Study details
- Official title
- A Phase 1/1b, Muticenter Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
- Sponsor
- LTZ Therapeutics, Inc.
- Conditions
- Colorectal Cancer · Advanced/Metastatic Solid Tumor · Solid Tumor (Phase I) · EPCAM · Colon Cancer
- Enrolling
- 152 people
- Starts
- 2026-10-28
- Est. completion
- 2031-12
- Design
- Open-label, non-randomized, sequential groups, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Advanced /metastatic colorectal tumors that have failed standard treatments
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1
- Adequate organ function based on laboratory testing
You can't join if
- Active infection with hepatitis B or C
- Uncontrolled CNS metastases
- Active autoimmune disease
- Clinically significant cardiovascular disease not adequately controlled with medication or impaired function
- Previous treatment with EpCAM targeting agent
- Pregnant or breast feeding
- Non-colorectal active malignancy within 3 years that could interfere with study interpretation
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openHonorHealth Research Institute
Scottsdale, Arizona, United States
- Stephanie Stanford · Contact480-323-1350stsanford@honorhealth.com
- Sunil Sharma, MD · Principal investigator
Recruiting
Study team
Sponsor
LTZ Therapeutics, Inc.
Study ID LTZ-232-001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.