Colorectal CancerPhase 1NCT07878988
This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
A Phase 1 study testing LTZ-232 in people with Colorectal Cancer and Advanced/Metastatic Solid Tumor, run by LTZ Therapeutics, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Advanced/Metastatic Solid Tumor, Solid Tumor (Phase I)
- What is being tested?
- LTZ-232
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2026to Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
HonorHealth Research Institute
Scottsdale, Arizona, 85258
Stephanie Stanford, 480-323-1350, stsanford@honorhealth.com
Sunil Sharma, MD
About this study
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
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.
Read the detailed description
LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.
- Conditions
- Colorectal Cancer, Advanced/Metastatic Solid Tumor, Solid Tumor (Phase I), EPCAM, Colon Cancer
- Being tested
- LTZ-232
- Medical subject headings
- Colorectal Neoplasms, Neoplasm Metastasis, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTZ-232Drug
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation in metastatic colorectal cancer | Experimental | Participants in this arm will participate in one (1) of up to eight (8) escalating defined dose level cohorts. Participants may receive LTZ-232 intravenously up to 24 months unless treatment discontinuation criteria are met. Receives: Drug: LTZ-232 |
| Safety/PK/Pharmacodynamic Cohorts | Experimental | Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels. Receives: Drug: LTZ-232 |
| Dose Expansion in metastatic colorectal cancer and other solid tumor types | Experimental | Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from dose escalation. Receives: Drug: LTZ-232 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the Safety and Tolerability of LTZ-232 in metastatic colorectal cancer and other solid tumors using the incidence, severity, and type of adverse events according to CTCAE v5.0.
To determine the incidence, severity, and type of adverse events according to NCI and CTCAE v5.0 and assessment of protocol defined dose limiting toxicity criteria.
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2031 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LTZ Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07878988
- Sponsor's protocol ID
- LTZ-232-001
- Status last verified
- Oct 2026
- First submitted
- 11 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07878988
- Acronym / sponsor ID
- LTZ-232-001
- Conditions
- Colorectal Cancer, Advanced/Metastatic Solid Tumor, Solid Tumor (Phase I), EPCAM, Colon Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- LTZ Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2031 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation in metastatic colorectal cancer | Experimental | Drug: LTZ-232Participants in this arm will participate in one (1) of up to eight (8) escalating defined dose level cohorts. Participants may receive LTZ-232 intravenously up to 24 months unless treatment discontinuation criteria are met. |
| Safety/PK/Pharmacodynamic Cohorts | Experimental | Drug: LTZ-232Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels. |
| Dose Expansion in metastatic colorectal cancer and other solid tumor types | Experimental | Drug: LTZ-232Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from dose escalation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LTZ-232LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met. | Drug | Dose Escalation in metastatic colorectal cancer, Dose Expansion in metastatic colorectal cancer and other solid tumor types, Safety/PK/Pharmacodynamic Cohorts |
Primary outcome
Characterize the Safety and Tolerability of LTZ-232 in metastatic colorectal cancer and other solid tumors using the incidence, severity, and type of adverse events according to CTCAE v5.0.
Time frame: Up to 24 months
To determine the incidence, severity, and type of adverse events according to NCI and CTCAE v5.0 and assessment of protocol defined dose limiting toxicity criteria.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing LTZ-232 in people with Colorectal Cancer and Advanced/Metastatic Solid Tumor, run by LTZ Therapeutics, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sherry Unabia (669-207-0084, sherry.unabia@ltztherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize the Safety and Tolerability of LTZ-232 in metastatic colorectal cancer and other solid tumors using the incidence, severity, and type of adverse events according to CTCAE v5.0. (time frame: Up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.