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Adult Solid TumorPhase 1NCT06277804

A Phase I Study of LTC004 Combin With FC in Patients With Advanced/Metastatic Malignancies Tumor

A Phase 1 study testing LTC004 in Combination With Cyclophosphamide and Fludarabine in people with Adult Solid Tumor, run by Letolab.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Adult Solid Tumor
What is being tested?
LTC004 in Combination With Cyclophosphamide and Fludarabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
No sites listed yet
Study dates
1 Mar 2024to 1 Jul 2027
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18 to 75 years；
  • Subjects with a histologically or cytologically confirmed diagnosis of a locally advanced or metastatic solid tumor or lymphoma that is not amenable to surgical treatment at the time of screening and that has failed after standard treatment as recommended by existing clinical standards of care or guidelines or that is not refractory to standard treatment and/or for which there is no currently effective standard of care.
  • The current open indication population is patients with soft tissue sarcoma, with the following specific requirements:
  • Histologically/cytologically confirmed diagnosis of unresectable or metastatic soft tissue sarcoma with failure of existing standard therapy or lack of effective treatment, as follows: 1) For pathological subtypes other than adenovascular soft tissue sarcoma and epithelioid sarcoma, failure of, or intolerance to, at least standard chemotherapy regimens of adriamycin or adriamycin in combination with isocyclophosphamide; and 2) For adenovascular soft tissue sarcoma and epithelioid sarcoma. Prior treatment failure or intolerance to a targeted agent [anti-angiogenic class such as amlotinib, pezopanib, etc.] is required; Note: Disease progression <6 months after the end of treatment in neoadjuvant or adjuvant patients is considered first-line treatment;
  • At least one measurable tumor lesion based on RECIST V1.1 criteria；
  • ECOG PS ≤1；
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  • Expected survival ≥12 weeks；
  • Adequate organ function；
  • 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；
  • 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 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;
  • 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 immunotherapy, including IL-2, IL-15, PD-1/L1 inhibitors, NK, and TCR-T cell therapy；
  • ≥2 malignant tumors within 5 years prior to first dose of drug；
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  • 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；
  • Persons with active tuberculosis infection within 1 year prior to enrollment by history or screening, or persons with a history of active tuberculosis infection more than 1 year ago without regular treatment；
  • 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 hepatitis B (hepatitis B virus titer > lower limit of detection) or hepatitis C at the time of screening；
  • Syphilis-positive patients at screening；
  • 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)；
  • Those who have experienced clinically significant bleeding symptoms within 3 months prior to the first dose of the drug；
  • Those who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, cyclophosphamide, azathioprine, methotrexate, thalidomide, etc.) within 2 weeks prior to the first dose;
  • Immunomodulatory medications within 2 weeks 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；
  • Tumor invasion into peripheral vital organs (e.g., aorta and trachea) or risk of esophageal-tracheal fistula or esophageal-pleural fistula; history of gastrointestinal perforation and/or fistula within 6 months prior to the first dose of the drug；
  • Received other unlisted clinical investigational drug or treatment within 4 weeks prior to 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: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced or Metastatic Malignancies Tumor

This was a multicenter, open PHASE I study of LTC004 in Combination With Cyclophosphamide and Fludarabine in Patients With Advanced/Metastatic Malignancies Tumor, the study design consisting of 2 phases: Phase Ia (Phase Ia dose escalation) and Phase Ib (Phase Ib expansion). The objective of this study was to evaluate combination safety, tolerability, pharmacokinetic,pharmacodynamics characteristics, and initial efficacy in advanced malignant tumors.

Being tested
LTC004 in Combination With Cyclophosphamide and Fludarabine

What participants receive

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

  • LTC004 in Combination With Cyclophosphamide and FludarabineDrug

    LTC004 was given on day 1 and cyclophosphamide (250 mg/m2) in combination with fludarabine (25 mg/m2) was given on days 3 and 4 of each cycle, Q3W, until disease progression, withdrawn informed or intolerable

Study groups in NCT06277804
Study groupRoleWhat they receive
Dose-escalation phaseExperimentalLTC004 combined with fludarabine, cyclophosphamide, "3+3"design； LTC004 was given on day 1 and cyclophosphamide (250 mg/m2) combined with fludarabine (25 mg/m2) on days 3 and 4 of each cycle.Q3W.
Receives: Drug: LTC004 in Combination With Cyclophosphamide and Fludarabine
Dose-expansion phaseExperimentalFurther evaluation of the safety and efficacy of this dosing regimen in patients with sarcoma who have failed standard treatment according to the RP2D identified in Dose-escalation phase.
Receives: Drug: LTC004 in Combination With Cyclophosphamide and Fludarabine

What is being measured

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

  1. Safety, tolerability and antitumor efficacy of Combination.

    Dose-limiting toxicity (DLT) Incidence;TEAE and SAE Incidence，Changes in safety indicators before and after administration

    Measured: up to 12 months

Secondary outcomes (1)

  1. PK Characteristics and immunogenicity of Combination

    Serum concentration and antibody positivity of LTC004

    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 posted26 Feb 2024
  2. Study start1 Mar 2024 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06277804
Sponsor's protocol ID
LTC004-102
Status last verified
Feb 2024
First submitted
7 Feb 2024
Last updated
26 Feb 2024
Results posted
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 1 study testing LTC004 in Combination With Cyclophosphamide and Fludarabine in people with Adult Solid Tumor, 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 11 inclusion and 26 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: opening soon, as of the sponsor's last update on 26 Feb 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 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?

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?

Safety, tolerability and antitumor efficacy of Combination. (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?

On the ClinicalTrials.gov record for NCT06277804.

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 26 Feb 2024.

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