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Advanced Solid TumorPhase 2NCT06490068

Study of LTC004 Combine With Toripalimab in Patient With Solid Tumors Resistant to Immunotherapy

A Phase 2 study testing LTC004+Toripalimab in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the efficacy and safety of LTC004 in combination with Toripalimab in 10 patients with advanced solid tumors resistant to first-line immunotherapy, all eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
LTC004+Toripalimab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteChina
Study dates
4 Jun 2024to 31 Mar 2026
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.
  • Locally advanced or metastatic solid tumors confirmed by pathology or cytology that cannot be surgically resected or can not be treated with radical concurrent chemoratherapy, and immune checkpoint inhibitor ± chemotherapy has become the standard first-line treatment, such as NSCLC, cervical cancer, head and neck squamous cell carcinoma, esophageal squamous cell carcinoma, etc. In addition, the patients had received no more than 1 line of systemic chemotherapy and no more than 1 line of systemic PD-1/PD-L1 inhibitor treatment at the same time or successively, and the treatment failed, and the previous PD-1/PD-L1 inhibitor treatment lasted more than 6 months, the best curative effect was CR/PR; No systemic antitumor therapy other than the above treatment was received (Note: if there is a second-line standard treatment, the second-line standard treatment is required to be completed before inclusion in this trial).
  • At least one measurable tumor lesion based on RECIST V1.1 criteria.
  • ECOG PS ≤1.
  • Expected survival ≥12 weeks.
  • 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.
  • 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 LAG3, TIGIT, IL-2, IL-15, CD3-like immunoagonists, and other cellular therapies.
Show all 24Show fewer
  • ≥2 malignant tumors within 5 years prior to first dose of drug.
  • irAE with ≥ grade 3 or discontinuation due to immunotherapy in the past.
  • 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 with clear anti-tumor indications in the package insert within 4 weeks prior to the first dose of study drug.
  • Severe infection, including but not limited to bacteremia requiring hospitalization and severe pneumonia, occurs within 4 weeks prior to the first medication; Active infection of grade CTCAE≥2 requiring treatment with systemic antibiotics was present within 2 weeks prior to the first dose.
  • The subject has active interstitial lung disease (ILD) or pneumonia; A history of needing hormones or other immunosuppressants to treat ILD or (non-infectious) pneumonia.
  • 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 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.

Trial locations and contacts

1 site in 1 country.

Ning Li contact

010-87788495

cancergcp@163.com

China1 site, 1 recruiting

  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    Beijing

    Ning Li, 010-87788495, cancergcp@163.com

    Ning Li

    Recruiting

Other trials in China

About this study

Official title: An Open, Single-arm, Phase II Clinical Study to Evaluate the Efficacy and Safety of LTC004 in Combination With Toripalimab in Patients With Advanced Solid Tumors Resistant to First-line Immunotherapy

To evaluate the efficacy and safety of LTC004 in combination with Toripalimab in 10 patients with advanced solid tumors resistant to first-line immunotherapy, all eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.

Read the detailed description

All eligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab regimen until disease progression, intolerance, informed withdrawal or up to 2 years of dosing, whichever occurred first.

Being tested
LTC004+Toripalimab

What participants receive

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

  • LTC004+ToripalimabDrug

    Also called LTC004 combine with Toripalimab

    LTC004 on D1 of Week 1 and D1 of week 3. IV,90μg/kg. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab.

    LTC004:D3,iv,45μg/kg,Q3W. Toripalimab:D1,iv,240mg,Q3W.

Study groups in NCT06490068
Study groupRoleWhat they receive
LTC004+ToripalimabExperimentalEligible subjects will receive LTC004 on day 1 of Week 1 and day 1 of week 3. Beginning at week 5, all subjects will receive LTC004 in combination with Toripalimab.
Receives: Drug: LTC004+Toripalimab

What is being measured

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

  1. ORR

    Antitumor efficacy of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy

    Measured: up to 12 months

Secondary outcomes (4)

  1. DCR

    Disease control rate of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy

    Measured: up to 12 months

  2. DOR

    Duration of Response of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy

    Measured: up to 12 months

  3. PFS

    Progression-Free Survival of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy

    Measured: up to 12 months

  4. OS

    Overall Survival of LTC004+Toripalimab treated patient with advanced solid tumors resistant to first-line immunotherapy

    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 posted8 Jul 2024
  2. Study start4 Jun 2024
  3. Primary completion31 Mar 2026 (estimated)
  4. Study completion31 Mar 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06490068
Sponsor's protocol ID
LTC004-204
Status last verified
Jun 2024
First submitted
29 Jun 2024
Last updated
8 Jul 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 2 study testing LTC004+Toripalimab in people with Advanced Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences 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 8 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 8 Jul 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 Ning Li (010-87788495, cancergcp@163.com), or a site near the patient. 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?

On the ClinicalTrials.gov record for NCT06490068.

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 8 Jul 2024.

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