Phase I/II of LB-100 Plus Doxorubicin vs. Doxorubicin Alone in First Line of Advanced Soft Tissue Sarcomas
NCT ID: NCT05809830
Last Updated: 2025-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
152 participants
INTERVENTIONAL
2023-05-29
2026-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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LB-100 plus doxorubicin
* LB-100 will be administered during the first 3 days of each cycle (days 1, 2, and 3) at RP2D as a 2-hour intravenous infusion (with 500 mL of physiological saline solution), every 3 weeks (21-day cycles until progression or intolerance).
* Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion after completion of LB-100, every 3 weeks (up to a maximum of 6 x 21-day cycles).
LB-100 plus Doxorrubicin
In Phase one the intervention will be LB-100 plus Doxorrubicin. The experimental arm in Phase II will also be LB-100 plus Doxorrubicin
Doxorubicin alone
Control: Doxorubicin will be administered only once (day 1) of each cycle at RP2D as a 20-minute infusion every 3 weeks (up to a maximum of 6 x 21-day cycles).
Doxorubicin
The control arm in Phase II will be Doxorrubicin alone
Interventions
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LB-100 plus Doxorrubicin
In Phase one the intervention will be LB-100 plus Doxorrubicin. The experimental arm in Phase II will also be LB-100 plus Doxorrubicin
Doxorubicin
The control arm in Phase II will be Doxorrubicin alone
Eligibility Criteria
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Inclusion Criteria
2. Age ≥ 18 years.
3. Diagnosis of advanced/metastatic soft tissue sarcoma (undifferentiated pleomorphic sarcoma, leiomyosarcoma, myxoid and hypercellular myxoid liposarcoma, myxofibrosarcoma, NOS sarcoma, synovial sarcoma, fibrosarcoma, or malignant nerve sheath tumor) confirmed by central pathology review.
4. Mandatory pre-treatment formalin-fixed paraffin embedded (FFPE) tumor tissue must be provided for all subjects without exception for central pathology review and the translational study. If archive biopsy is not available or is older than 3 months, the patient must be willing to have a pre-treatment re-biopsy of primary or metastatic tumor (baseline biopsy) within 28 days prior to enrollment.
5. The patient must be willing to undergo a second mandatory biopsy just before the initiation of the 3rd cycle and agree that this sample is used for the translational study.
6. Measurable disease according to RECIST v1.1 criteria.
7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
8. The patient must be naïve of any previous treatment with anthracyclines (not even in adjuvant chemotherapy).
9. Adequate organ, hepatic, renal, cardiac, and hematologic function.
10. Laboratory tests as follows:
* Absolute neutrophil count ≥ 1,200/mm³
* Platelet count ≥ 100,000/mm³
* Hg \> 9 g/dL
* Bilirubin ≤ 1.5 mg/dL
* PT and INR ≤ 1.5
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 60 mL/min
* Blood glucose \< 150 mg/dL
11. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan assessed within 28 days before enrollment.
12. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Patients must not be pregnant or nursing at study entry.
13. Women and men of reproductive potential must have agreed to use an effective contraceptive method during study treatment and for 3 months after the last dose of study drug.
1. The patient must provide written informed consent prior to performance of study-specific procedures and must be willing to comply with treatment and follow-up. Informed consent must be obtained prior to start of the screening process. Procedures conducted as part of the patient's routine clinical management (e.g. blood count, imaging tests, etc.) and obtainedprior to signature of informed consent may be used for screening or baseline purposes as long as these procedures are conducted as specified in the protocol.
2. Age ≥ 18 years.
3. Diagnosis of advanced/metastatic soft tissue sarcoma (undifferentiated pleomorphic sarcoma or leiomyosarcoma) confirmed by central pathology review.
4. Mandatory pre-treatment formalin-fixed paraffin embedded (FFPE) tumor tissue must be provided for all subjects without exception for central pathology review and the translational study. If archive biopsy is not available or is older than 3 months, the patient must be willing to have a pre-treatment re-biopsy of primary or metastatic tumor (baseline biopsy) within 28 days prior to enrollment.
5. Measurable disease according to RECIST v1.1 criteria.
6. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1.
7. The patient must be naïve of any previous treatment with anthracyclines (not even in adjuvant chemotherapy).
8. Adequate organ, hepatic, renal, cardiac, and hematologic function.
9. Laboratory tests as follows:
* Absolute neutrophil count ≥ 1,200/mm³
* Platelet count ≥ 100,000/mm³
* Hg \> 9 g/dL
* Bilirubin ≤ 1.5 mg/dL
* PT and INR ≤ 1.5
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 mg/dL or estimated creatinine clearance ≥ 60 mL/min
* Blood glucose \< 150 mg/dL 10. Left ventricular ejection fraction ≥ 50% by echocardiogram or MUGA scan assessed within 28 days before enrollment.
11\. Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to enrollment. Patients must not be pregnant or nursing at study entry.
12\. Women and men of reproductive potential must have agreed to use an effective contraceptive method during study treatment and for 3 months after the last dose of study drug.
Exclusion Criteria
3. Uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade \>= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (\>= Grade 3).
4. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
5. Any of the following diseases/illnesses within the previous 6 months:
* Myocardial infarction
* Severe or unstable angina
* Coronary or peripheral artery bypass graft
* Cerebrovascular accident or transient ischemic attack (TIA)
* Pulmonary embolism
6. Evidence of a bleeding diathesis.
7. Ongoing cardiac dysrhythmias \> Grade 2.
8. Prolonged QTc interval (i.e., QTc \> 450 msec for males or QTc \> 470 msec for females) on baseline ECG.
9. History of allergy to study drug components.
10. History of another cancer with the exception of adequately treated basal cell carcinoma or in situ cervical cancer, or with a relapse-free interval longer than 3 years after treatment of the primary cancer with no substantial risk of recurrence.
11. Presence of brain or central nervous system metastases at the time of enrollment.
12. Patient is unwilling to provide mandatory translational tumor samples or biopsies (if required) cannot be easily taken.
1. Diagnosis of any sarcoma different from undifferentiated pleomorphic sarcoma and leiomyosarcoma.
3. Uncontrolled intercurrent illness including (not limited to): symptomatic congestive heart failure (CHF) (New York Heart Association \[NYHA\] III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 24 weeks prior to registration, unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade \>= 2), known psychiatric illness that would limit study compliance, intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (\>= Grade 3).
4. HBV and HCV serologies must be performed prior to inclusion. If HbsAg is positive it is recommended to reject the existence of replicative phase (HbaAg+, DNA VHB+). If these were positives the inclusion is not recommended, remaining at investigators' discretion the preventive treatment with lamivudine. If a potential patient is positive for anti-HCV antibodies, presence of the virus should be ruled out with a qualitative PCR, or the patient should NOT be included in the study (if a qualitative PCR cannot be performed then patient will not be able to enter the study).
5. Any of the following diseases/illnesses within the previous 6 months:
* Myocardial infarction
* Severe or unstable angina
* Coronary or peripheral artery bypass graft
* Cerebrovascular accident or transient ischemic attack (TIA)
* Pulmonary embolism
6. Evidence of a bleeding diathesis.
7. Ongoing cardiac dysrhythmias \> Grade 2.
8. Prolonged QTc interval (i.e., QTc \> 450 msec for males or QTc \> 470 msec for females) on baseline ECG.
9. History of allergy to study drug components.
10. History of another cancer with the exception of adequately treated basal cell carcinoma or in situ cervical cancer, or with a relapse-free interval longer than 3 years after treatment of the primary cancer with no substantial risk of recurrence.
11. Presence of brain or central nervous system metastases at the time of enrollment.
12. Patient is unwilling to provide mandatory translational tumor samples or biopsies (if required) cannot be easily taken.
18 Years
ALL
No
Sponsors
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Grupo Espanol de Investigacion en Sarcomas
OTHER
Responsible Party
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Principal Investigators
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Javier Martín Broto
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Fundación Jiménez Díaz
Locations
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Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital Fundación Jiménez Díaz
Madrid, Madrid, Spain
Hospital Universitario La Paz
Madrid, Madrid, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia, Murcia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Valencia, Spain
Countries
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Other Identifiers
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GEIS-74
Identifier Type: -
Identifier Source: org_study_id
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