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Advanced/Metastatic Colorectal CancerPhase 2NCT06322563

Combination of LTC004 and Regorafenib to Treat Patients With Advanced/Metastatic CRC

A Phase 2 study testing LTC004+regorafenib in people with Advanced/Metastatic Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in combination with regorafenib in patients with mCRC. A safety introductory trial was conducted to receive LTC004 in combination with regorafenib before starting the formal trial. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced/Metastatic Colorectal Cancer
What is being tested?
LTC004+regorafenib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteChina
Study dates
1 Apr 2024to 1 Mar 2025
Phase
Phase 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.
  • Those who have progressed on, or are intolerant to, at least one prior first- and second-line systemic antitumor therapy for metastatic colorectal cancer. Patients must have received fluorouracil, oxaliplatin, and irinotecan-based chemotherapy, and patients with mCRC who have previously received or are not candidates for anti-VEGF therapy, anti-epidermal growth factor receptor therapy (RAS wild-type).
  • Pre-existing MMR, MSS, HER2, PD-L1, RAS, and BRAF status with corresponding supporting documentation.
  • At least one measurable tumor lesion based on RECIST V1.1 criteria.
  • ECOG PS ≤1.
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  • Expected survival ≥12 weeks.
  • able to Swallow whole pills.
  • 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.
  • 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.
  • 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 immunotherapies such as PD-1/L1 inhibitors, LAG3, TIGIT, IL-2, IL-15, CD3-like immunoagonists, and other cellular therapies, as well as other TKI agents (e.g., furaquintinib, regorafenib, etc.).
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  • ≥2 malignant tumors within 5 years prior to first dose of drug.
  • Patients who have received any chemotherapy or anti-tumor monoclonal antibody drugs within 4 weeks prior to the first dose of study drug (excluding mitomycin and nitrosoureas within 6 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.
  • Moderate to severe dyspnea at rest due to advanced cancer or its complications, severe primary lung disease, current need for continuous oxygen therapy, or clinically active interstitial lung disease (ILD) or pneumonia; Grade ≥3 interstitial pneumonia during prior antineoplastic therapy.
  • Presence of severe infections including, but not limited to, bacteremia and severe pneumonia requiring hospitalization within 4 weeks prior to the first dose; active infections with CTCAE ≥ grade 2 requiring treatment with systemic antibiotics within 2 weeks prior to the first dose.
  • History of serious cardiovascular disease.
  • Previous total gastrectomy, chronic diarrhea, active inflammatory gastrointestinal disease, or any other condition causing malabsorption syndrome.
  • Active bleeding disorder, including gastrointestinal bleeding, as evidenced by vomiting of blood, profuse hemoptysis, or black stools, in the 6 months prior to enrollment.
  • Active hepatitis B (hepatitis B virus DNA measurement ≥1000 copies/mL or 200 IU/mL); hepatitis C infection (hepatitis C antibody positive and HCVRNA above the lower limit of detection in research centers); syphilis infection, active tuberculosis.
  • Active, or previous autoimmune disease with potential for recurrence at the time of screening.
  • 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 first dose.
  • 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 biopsy).
  • Adverse effects of prior antineoplastic therapy have not returned to a CTCAE version 5.0 grade rating of ≤ grade 1 (with the exception of alopecia and grade 2 neurotoxicity due to chemotherapeutic agents, and grade 2 hypothyroidism due to antineoplastic therapy).
  • Patients with prior allogeneic bone marrow/hematopoietic stem cell transplantation or solid organ transplantation.
  • Pregnant, 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.)

Trial locations and contacts

1 site in 1 country.

Ting Deng contact

15802243063

18526812877@163.com

China1 site

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

Other trials in China

About this study

Official title: An Open, Single-arm, Phase II Clinical Study Evaluating the Safety and Initial Efficacy of LTC004 in Combination With Regorafenib in the Treatment of Metastatic Colorectal Cancer

This is a phase II clinical study to evaluate the safety, tolerability and preliminary antitumor activity of LTC004 in combination with regorafenib in patients with mCRC. A safety introductory trial was conducted to receive LTC004 in combination with regorafenib before starting the formal trial. After completing a 28-day safety assessment, safety will be confirmed before entering the formal trial phase. Further evaluation of the safety and efficacy of LTC004 in combination with regorafenib in the treatment of mCRC

Being tested
LTC004+regorafenib
Keywords
mCRC
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LTC004+regorafenibDrug

    LTC004,90μg/kg,IV,Day 1,Q3W; Regorafenib:Orally once daily for the first 21 days of each cycle, with 28 days as 1 cycle. Cycle 1 was dose-escalation with a starting dose of 80 mg/d, increasing by 40 mg per week until 160 mg/d, i.e., 80 mg/d in week 1 (D1~D7), 120 mg/d in week 2 (D8~D14), and 160 mg/d in week 3 (D15~D21);

Study groups in NCT06322563
Study groupRoleWhat they receive
Safety introduction trial：LTC004+regorafenibExperimentalLTC004 in combination with regorafenib safety introduction trial and completing a 28-day safety assessment
Receives: Drug: LTC004+regorafenib
Formal trial phase：LTC004+regorafenibExperimentalAfter Safety introduction trial, safety will be confirmed before entering the formal trial phase.Further evaluation of the safety and efficacy of LTC004 in combination with regorafenib in the treatment of mCRC
Receives: Drug: LTC004+regorafenib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Treatment-Emergent Adverse Events-Safety and Tolerability

    TEAE and changes in safety indicators (12-ECG,Laboratory inspection items,Cardiopulmonary function and so on)before and after administration

    Measured: up to 12 months

  2. SAE-Safety and Tolerability

    SAE and changes in safety indicators (12-ECG,Laboratory inspection items,Cardiopulmonary function and so on)before and after administration

    Measured: up to 12 months

Secondary outcomes (4)

  1. ORR

    Antitumor efficacy of LTC004+Regorafenib

    Measured: up to 12 months

  2. DCR

    Antitumor efficacy of LTC004+Regorafenib

    Measured: up to 12 months

  3. PFS

    Antitumor efficacy of LTC004+Regorafenib

    Measured: up to 12 months

  4. OS

    Antitumor efficacy of LTC004+Regorafenib

    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.

  1. First posted21 Mar 2024
  2. Study start1 Apr 2024 (estimated)
  3. Primary completion1 Mar 2025 (estimated)
  4. Study completion1 Mar 2025 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06322563
Sponsor's protocol ID
LTC004-202
Status last verified
Feb 2024
First submitted
26 Feb 2024
Last updated
21 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LTC004+regorafenib in people with Advanced/Metastatic Colorectal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 1 site in China.

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 11 inclusion and 24 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 21 Mar 2024. 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 China. 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 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?

Contact Ting Deng (15802243063, 18526812877@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment-Emergent Adverse Events-Safety and Tolerability (time frame: up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06322563.

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 21 Mar 2024.

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