RECRUITING

A First-in-Human, Phase 1/2 Study of LAT010 in Patients with Advanced Solid Tumors (LIGHTSPEED-1)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is an open-label, multicenter, Phase 1/2, first-in-human (FIH), dose-escalation and cohort-expansion study of LAT010 to evaluate the safety, tolerability, immunogenicity, PK, PD, and antitumor activity in patients with advanced solid tumors. The study consists of 2 parts: Phase 1 dose-escalation and Phase 2 cohort expansion.

Official Title

A Phase 1/2, Dose-Escalation and Cohort-Expansion Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Efficacy of LAT010 in Patients with Advanced Solid Tumors (LIGHTSPEED-1)

Quick Facts

Study Start:2024-06-05

Study Completion:2027-03

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06277219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Patients have voluntarily signed the informed consent. 2. Patients are willing and able to comply with the protocol-related procedures (including screening evaluations), such as visits, treatment plans, laboratory assessments, and other requirements of the study. 3. Male or female aged ≥18 years old. 4. Patients meet the following diagnoses: * Patients have histologically or cytologically documented diagnosis of locally advanced or metastatic solid tumors with evidence of progressive disease according to RECIST 1.1, and * Patients are intolerant to or have progressed on all established standard therapies associated with clinical benefit or patients consent that they may be delaying or forgoing treatments known to confer a clinical benefit for their disease, or * No additional established line of standard therapy is available, or * There is a contraindication for the indicated standard therapies in the opinion of the Investigator. 5. Patients have at least one measurable tumor lesion, defined as a lesion with the longest measurable diameter of non-lymph node lesions by imaging (CT/MRI) of ≥10 mm or the short diameter of a single pathological lymph node lesion of ≥15 mm. 6. Expected life expectancy of \>12 weeks per the Investigator. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Phase 1. ECOG score of 0 to 2 for Phase 2. 8. If a patient has had prior major surgery, at least 4 weeks must have elapsed at the time of screening. 9. Patients have adequate pulmonary, cardiovascular, hematological, liver, and renal function, per Investigator assessment. 10. Patients have not received any IL-2 therapy within 12 months before the first dose of LAT010. 11. Laboratory values at screening are as follows: 12. Any toxicity of previous treatment has recovered to Grade ≤1, unless the toxicity is judged by the Investigator to pose no safety risk, such as alopecia (any grade) or fatigue (up to Grade 2 allowed). 13. Female patients of childbearing potential and sexually active male patients with female partners of childbearing potential must agree to use effective contraceptive measures (including concomitant use of a spermicide with barrier method, intrauterine device, or hormonal contraceptives) from signing the informed consent form to at least 90 days after the last dose of LAT010. Female patients of childbearing age and women \<12 months after menopause must have a negative pregnancy test result within 7 days before the first dose of LAT010. 14. Male patients must not donate sperm starting at screening and throughout the study period and for at least 90 days after the final study drug administration. 15. Patients must meet the following criteria: 1. Patients are willing and able to undergo baseline and on-treatment biopsies of the tumor. If a patient has residual tumor masses that can only be accessed with significant risk, available archived biopsies (frozen or formalin-fixed) may serve as baseline specimens with the Sponsor's approval. 2. Patients have been diagnosed and histologically confirmed with a tumor type being selected for the Phase 2 trial. 3. Patients have received the established standard therapies for the selected tumor type prior to enrolling to this study and patients consent that they may be delaying or forgoing specific treatments known to confer a clinical benefit for their disease. 4. Must have received no more than 1 prior line of anti-angiogenic therapy, e.g., anti-vascular endothelial growth factor (anti-VEGF) therapy	1. Cardiovascular exclusions: 1. Patient has a medical history of an arterial thrombotic event, stroke, or transient ischemia attack within the past 6 months. 2. Patient has a medical history of symptomatic congestive heart failure (New York Heart Association classes III or IV) or an uncontrolled clinically significant cardiac arrhythmia that requires treatment. 3. Patient has a medical history of myocardial infarction or unstable angina within 6 months before the first dose of LAT010. 4. Patient has a QTc prolongation to \>480 milliseconds (ms) based on a 12-lead ECGs in triplicate. 2. Other exclusions: 1. Patient is actively enrolled in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study. 2. Use of another systemic anti-cancer therapy within 3 weeks or 5 half- lives after the first dose of LAT010, whichever is shorter. 3. Patient has active central nervous system (CNS) metastases. However, definitely treated CNS metastases (such as surgery, radiotherapy) that are stable for at least 2 weeks prior to the first dose of LAT010 are acceptable. 4. Patient has another active primary malignancy that has not been treated with curative intent. Exceptions could be made upon discussion with the Medical Monitor. However, non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer are acceptable. 5. Patient has history of severe irAEs from a previous treatment, which are defined as a Grade 4 event requiring corticosteroid treatment or a Grade 3 event requiring corticosteroid treatment of \>10 mg/day prednisone or equivalent dose for \>12 weeks. 3. Recent medical concerns exclusions: 1. Patient has evidence of active infection requiring IV antibiotics within 7 days prior to the first dose of LAT010. 2. Patient has active uncontrolled bleeding within 7 days prior to the first dose of LAT010. 3. Patient has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to the first dose of LAT010. 4. Patient has had a live virus vaccine within 30 days prior to the first dose of LAT010 (Note: Inactivated seasonal flu vaccine is acceptable. COVID-19 vaccination is also allowed.) 4. Patient has known replicating human immunodeficiency virus infection, active hepatitis B infection, or hepatitis C infection. However, hepatitis B virus (HBV) carriers without active disease (HBV DNA titer \< 1000 cps/mL or 200 IU/mL) or patients with cured hepatitis C (negative HCV RNA test) may be enrolled. Patients with treated non-replicative disease are acceptable. 5. Patient is taking corticosteroids \>10 mg/day of prednisone or equivalent. 6. Patient has had an organ transplantation or is on systemic immunosuppressive therapy. 7. Patient has a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19) on Day -2 or Day -1. 8. Patient has a serious illness considered by the Investigator to be unsuitable for participating in this study. 9. Any condition that, in the opinion of the Investigator, may interfere with the evaluation of the study drug or interpretation of the patient's safety or study results. 10. Patient has a history of sensitivity to LAT010, or components thereof, or a history of drug or other allergy that in the opinion of the Investigator or Medical Monitor (if appropriate), contraindicates their participation. 11. Patient has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, that is deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent form (ICF), adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results. 12. Patient is breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose of LAT010. 13. Patient is unwilling or unable to follow protocol requirements.

Inclusion Criteria

Exclusion Criteria

1. Patients have voluntarily signed the informed consent.
2. Patients are willing and able to comply with the protocol-related procedures (including screening evaluations), such as visits, treatment plans, laboratory assessments, and other requirements of the study.
3. Male or female aged ≥18 years old.
4. Patients meet the following diagnoses:
* Patients have histologically or cytologically documented diagnosis of locally advanced or metastatic solid tumors with evidence of progressive disease according to RECIST 1.1, and
* Patients are intolerant to or have progressed on all established standard therapies associated with clinical benefit or patients consent that they may be delaying or forgoing treatments known to confer a clinical benefit for their disease, or
* No additional established line of standard therapy is available, or
* There is a contraindication for the indicated standard therapies in the opinion of the Investigator.
5. Patients have at least one measurable tumor lesion, defined as a lesion with the longest measurable diameter of non-lymph node lesions by imaging (CT/MRI) of ≥10 mm or the short diameter of a single pathological lymph node lesion of ≥15 mm.
6. Expected life expectancy of \>12 weeks per the Investigator.
7. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 for Phase 1. ECOG score of 0 to 2 for Phase 2.
8. If a patient has had prior major surgery, at least 4 weeks must have elapsed at the time of screening.
9. Patients have adequate pulmonary, cardiovascular, hematological, liver, and renal function, per Investigator assessment.
10. Patients have not received any IL-2 therapy within 12 months before the first dose of LAT010.
11. Laboratory values at screening are as follows:
12. Any toxicity of previous treatment has recovered to Grade ≤1, unless the toxicity is judged by the Investigator to pose no safety risk, such as alopecia (any grade) or fatigue (up to Grade 2 allowed).
13. Female patients of childbearing potential and sexually active male patients with female partners of childbearing potential must agree to use effective contraceptive measures (including concomitant use of a spermicide with barrier method, intrauterine device, or hormonal contraceptives) from signing the informed consent form to at least 90 days after the last dose of LAT010. Female patients of childbearing age and women \<12 months after menopause must have a negative pregnancy test result within 7 days before the first dose of LAT010.
14. Male patients must not donate sperm starting at screening and throughout the study period and for at least 90 days after the final study drug administration.
15. Patients must meet the following criteria:
1. Patients are willing and able to undergo baseline and on-treatment biopsies of the tumor. If a patient has residual tumor masses that can only be accessed with significant risk, available archived biopsies (frozen or formalin-fixed) may serve as baseline specimens with the Sponsor's approval.
2. Patients have been diagnosed and histologically confirmed with a tumor type being selected for the Phase 2 trial.
3. Patients have received the established standard therapies for the selected tumor type prior to enrolling to this study and patients consent that they may be delaying or forgoing specific treatments known to confer a clinical benefit for their disease.
4. Must have received no more than 1 prior line of anti-angiogenic therapy, e.g., anti-vascular endothelial growth factor (anti-VEGF) therapy

1. Cardiovascular exclusions:
1. Patient has a medical history of an arterial thrombotic event, stroke, or transient ischemia attack within the past 6 months.
2. Patient has a medical history of symptomatic congestive heart failure (New York Heart Association classes III or IV) or an uncontrolled clinically significant cardiac arrhythmia that requires treatment.
3. Patient has a medical history of myocardial infarction or unstable angina within 6 months before the first dose of LAT010.
4. Patient has a QTc prolongation to \>480 milliseconds (ms) based on a 12-lead ECGs in triplicate.
2. Other exclusions:
1. Patient is actively enrolled in another clinical study, unless it is an observational (noninterventional) clinical study or the follow-up component of an interventional study.
2. Use of another systemic anti-cancer therapy within 3 weeks or 5 half- lives after the first dose of LAT010, whichever is shorter.
3. Patient has active central nervous system (CNS) metastases. However, definitely treated CNS metastases (such as surgery, radiotherapy) that are stable for at least 2 weeks prior to the first dose of LAT010 are acceptable.
4. Patient has another active primary malignancy that has not been treated with curative intent. Exceptions could be made upon discussion with the Medical Monitor. However, non-metastatic cutaneous basal cell or squamous cell carcinoma, or non-muscle invasive bladder cancer are acceptable.
5. Patient has history of severe irAEs from a previous treatment, which are defined as a Grade 4 event requiring corticosteroid treatment or a Grade 3 event requiring corticosteroid treatment of \>10 mg/day prednisone or equivalent dose for \>12 weeks.
3. Recent medical concerns exclusions:
1. Patient has evidence of active infection requiring IV antibiotics within 7 days prior to the first dose of LAT010.
2. Patient has active uncontrolled bleeding within 7 days prior to the first dose of LAT010.
3. Patient has serious or non-healing wound, fistula, skin ulcer, or non-healing bone fracture within 7 days prior to the first dose of LAT010.
4. Patient has had a live virus vaccine within 30 days prior to the first dose of LAT010 (Note: Inactivated seasonal flu vaccine is acceptable. COVID-19 vaccination is also allowed.)
4. Patient has known replicating human immunodeficiency virus infection, active hepatitis B infection, or hepatitis C infection. However, hepatitis B virus (HBV) carriers without active disease (HBV DNA titer \< 1000 cps/mL or 200 IU/mL) or patients with cured hepatitis C (negative HCV RNA test) may be enrolled. Patients with treated non-replicative disease are acceptable.
5. Patient is taking corticosteroids \>10 mg/day of prednisone or equivalent.
6. Patient has had an organ transplantation or is on systemic immunosuppressive therapy.
7. Patient has a positive test result for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) viral RNA test, either asymptomatic or present with symptoms of Coronavirus disease 2019 (COVID-19) on Day -2 or Day -1.
8. Patient has a serious illness considered by the Investigator to be unsuitable for participating in this study.
9. Any condition that, in the opinion of the Investigator, may interfere with the evaluation of the study drug or interpretation of the patient's safety or study results.
10. Patient has a history of sensitivity to LAT010, or components thereof, or a history of drug or other allergy that in the opinion of the Investigator or Medical Monitor (if appropriate), contraindicates their participation.
11. Patient has any illness, medical condition, organ system dysfunction, or social situation, including mental illness or substance abuse, that is deemed by the Investigator to be likely to interfere with a patient's ability to sign the informed consent form (ICF), adversely affect the patient's ability to cooperate and participate in the study, or compromise the interpretation of study results.
12. Patient is breastfeeding or pregnant as confirmed by pregnancy tests performed within 7 days before the first dose of LAT010.
13. Patient is unwilling or unable to follow protocol requirements.

Contacts and Locations

Study Contact

Lightspeed Study Contact

CONTACT

412-401-3699

lightspeed-1@latticon.com

John Li, PhD

CONTACT

john.li@latticon.com

Principal Investigator

John Li, PhD

STUDY_CHAIR

Latticon Antibody Therapeutics, Inc

Study Locations (Sites)

D&H Cancer Research Center

Margate, Florida, 33063

United States

Huntsman Cancer Institute

Salt Lake City, Utah, 84112

United States

Collaborators and Investigators

Sponsor: Latticon Antibody Therapeutics, Inc

John Li, PhD, STUDY_CHAIR, Latticon Antibody Therapeutics, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-05

Study Completion Date2027-03

Study Record Updates

Study Start Date2024-06-05

Study Completion Date2027-03

Terms related to this study

Additional Relevant MeSH Terms

Advanced Solid Tumor