Locally Advanced or Metastatic CRCPhase 1/2NCT06384235
Phase II Clinical Study of LTC004 in Patients With mCRC
A Phase 1/2 study testing LTC004 in people with Locally Advanced or Metastatic CRC, run by Letolab.
Trial summary
This is a phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC，Enrollment of 10 evaluable subjects in Phase I. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Locally Advanced or Metastatic CRC
- What is being tested?
- LTC004
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 25 Apr 2024to 23 Aug 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years.
- Non-radical resectable metastatic colorectal cancer confirmed by histology or cytology (pathology report required).
- Those who have progressed on, or are intolerant to, at least three lines of prior systemic antitumor therapy for metastatic colorectal cancer. Patients must have received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, as well as patients with mCRC who have received or are not candidates for prior anti-VEGF therapy, TKI agents, and anti-epidermal growth factor receptor therapy (RAS wild-type).
- At least one measurable tumor lesion based on RECIST V1.1 criteria.
- ECOG PS ≤1.
- Expected survival ≥12 weeks.
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- Adequate organ function.
- Patients, both females and males, of reproductive potential must agree to use adequate contraception during and for 6 months after the last infusion of LTC004.
- Patients who have received any chemotherapy or anti-tumor monoclonal antibody drugs within 4 weeks prior to the first dose of study drug.small molecule targeted drugs within 2 weeks prior to the first dose of study drug; Chinese medicine therapy (Chinese medicine therapy with clear anti-tumor indications in the package insert within 4 weeks prior to the first dose of study drug.
- Understands and provides written informed consent and willing to follow the requirements specified in protocol.
Who cannot join
- History of severe hypersensitivity reactions to other mAbs.
- Untreated, unstable or uncontrolled central nervous system (CNS) metastases with following exceptions:A. Clinically stable MRI scans and no progressive or uncontrolled neurologic symptoms or signs for at least 4 weeks prior to the first study treatment.
- Tumor invasion of vital arteries resulting in high risk of bleeding, significant risk of perforation or already formed fistulae.
- Patients with uncontrolled pleural effusion, pericardial effusion or abdominal effusion as judged by the investigator at screening.
- Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled.
- Previous antitumor regimens include immunotherapy such as PD-1/L1 inhibitors, LAG3, TIGIT, IL-2, IL-15, CD3-like immunoagonists, and other cellular therapies.
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- ≥2 malignant tumors within 5 years prior to first dose of drug.
- Moderate to severe dyspnea at rest, severe primary lung disease,current need for continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonia due to advanced cancer or its complications; Grade ≥3 interstitial pneumonia during prior antineoplastic therapy.
- Presence of severe infection within 4 weeks prior to first dose of medication.Presence of active infection requiring systemic antibiotic therapy with CTCAE grade ≥2 within 2 weeks prior to first dose.
- History of serious cardiovascular disease.
- Active bleeding disorders, including gastrointestinal bleeding, as evidenced by vomiting of blood, profuse hemoptysis, or black stools, have occurred in the 6 months prior to enrollment.
- Active hepatitis B,hepatitis C infection,syphilis infection, active tuberculosis.
- Patients with active, or previous autoimmune disease with potential for recurrence.
- Immunodeficiency diseases or history of such diseases, including a positive serologic test for human immunodeficiency virus (HIV).
- Arterial/venous thrombotic events within 6 months prior to the first dose of the drug.
- Those who received radical radiation therapy within 4 weeks prior to the first dose and those who received palliative radiation within 14 days prior to the first dose.
- Use of live or attenuated vaccines within 4 weeks prior to the first dose,or anticipated need for live or attenuated vaccines during the study period.
- Major surgery (other than surgery for diagnostic purposes) within 4 weeks prior to the first dose, anticipation of major surgery (other than surgery for diagnostic purposes) during the study period, or diagnostic or low-invasive surgery within 7 days prior to the first dose (excluded for puncture biopsies).
- Adverse effects of prior antitumor therapy have not recovered to CTCAE version 5.0 grade rating ≤1.
- Patients who have received a previous allogeneic bone marrow/hematopoietic stem cell transplant or solid organ transplant.
- Pregnant and lactating women.
- Subjects who in the judgment of the investigator, have a history of other serious systemic disease or are unfit to participate in this trial for any other reason (the presence of psychiatric disorders in the patient that may affect compliance with the trial, alcohol, drug or substance abuse,etc.)
About this study
Official title: An Open, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of LTC004 Monotherapy in Patients With Metastatic Colorectal Cancer Who Have Failed Third-Line and Above Standard Treatment
This is a phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC，Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission，proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004
- Conditions
- Locally Advanced or Metastatic CRC
- Being tested
- LTC004
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LTC004Drug
LTC004,45μg/kg,IV,Day 1,Q3W;
| Study group | Role | What they receive |
|---|---|---|
| PHASE 1 | Experimental | Enrollment of 10 consecutive evaluable CRC subjects with failure of existing standard therapy or lack of effective treatment Treated with LTC004 in Phase I Receives: Drug: LTC004 |
| PHASE 2 | Experimental | If ≥2 subjects experience objective remission in PHASE 1, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004 Receives: Drug: LTC004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
Antitumor efficacy of LTC004 treated CRC patients
Measured: up to 12 months
Secondary outcomes (3)
DOR
Duration of Response of LTC004 treated CRC patients
Measured: up to 12 months
PFS
Progression-Free Survival of LTC004 treated sarcoma patients
Measured: up to 12 months
OS
Overall Survival of LTC004 treated CRC patients
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start25 Apr 2024 (estimated)
- Primary completion23 Aug 2025 (estimated)
- Study completion23 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic CRCStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Letolab
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384235
- Sponsor's protocol ID
- LTC004-203
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-Arm, Phase II Clinical Study Evaluating the Efficacy and Safety of LTC004 Monotherapy in Patients With Metastatic Colorectal Cancer Who Have Failed Third-Line and Above Standard Treatment
- ClinicalTrials.gov ID
- NCT06384235
- Acronym / sponsor ID
- LTC004-203
- Conditions
- Locally Advanced or Metastatic CRC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LetolabIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2024 (estimated)
- Primary completion
- 23 Aug 2025 (estimated)
- Study completion
- 23 Aug 2025 (estimated)
- First posted
- 25 Apr 2024 (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 phase II clinical study to evaluate the safety and antitumor activity of LTC004 in patients with locally advanced or metastatic CRC，Enrollment of 10 evaluable subjects in Phase I. If ≥2 subjects experience objective remission，proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PHASE 1 | Experimental | Drug: LTC004Enrollment of 10 consecutive evaluable CRC subjects with failure of existing standard therapy or lack of effective treatment Treated with LTC004 in Phase I |
| PHASE 2 | Experimental | Drug: LTC004If ≥2 subjects experience objective remission in PHASE 1, proceed to Phase II to enroll an additional 20 evaluable subjects to further evaluation of the safety and efficacy of LTC004 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Aged 18 to 75 years.
- Non-radical resectable metastatic colorectal cancer confirmed by histology or cytology (pathology report required).
- Those who have progressed on, or are intolerant to, at least three lines of prior systemic antitumor therapy for metastatic colorectal cancer. Patients must have received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, as well as patients with mCRC who have received or are not candidates for prior anti-VEGF therapy, TKI agents, and anti-epidermal growth factor receptor therapy (RAS wild-type).
- At least one measurable tumor lesion based on RECIST V1.1 criteria.
- ECOG PS ≤1.
Key exclusion criteria (22 listed)
- History of severe hypersensitivity reactions to other mAbs.
- Untreated, unstable or uncontrolled central nervous system (CNS) metastases with following exceptions:A. Clinically stable MRI scans and no progressive or uncontrolled neurologic symptoms or signs for at least 4 weeks prior to the first study treatment.
- Tumor invasion of vital arteries resulting in high risk of bleeding, significant risk of perforation or already formed fistulae.
- Patients with uncontrolled pleural effusion, pericardial effusion or abdominal effusion as judged by the investigator at screening.
- Patients with untreated or clinically symptomatic spinal cord compression that has not been controlled.
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 |
|---|---|---|
| LTC004LTC004,45μg/kg,IV,Day 1,Q3W; | Drug | PHASE 1, PHASE 2 |
Primary outcome
ORR
Time frame: up to 12 months
Antitumor efficacy of LTC004 treated CRC patients
3 secondary outcomes
DOR
Time frame: up to 12 months
PFS
Time frame: up to 12 months
OS
Time frame: up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing LTC004 in people with Locally Advanced or Metastatic CRC, run by Letolab.
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 10 inclusion and 22 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: status not confirmed, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to 12 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 25 Apr 2024.