A Phase I/II Study of LM-101 Injection in Patients With Advanced Malignant Tumors

NCT05615974 | Recruiting Phase 1

• 1 other identifier: LM101-01-103
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 5

Brief Summary

This study is to assess the safety and tolerability, obtain Maximum Tolerated Dose (MTD) and/or the recommended phase 2 dose (RP2D) of LM-101 as a single agent or in combination in patients with advanced malignant tumors

Conditions

Malignant Tumors

Outcome Measures

Primary Outcomes (21)

• Incidence of adverse events (AEs)

  Phase 1

  48 weeks

• Incidence of dose-limitingtoxicity (DLT)

  Phase 1

  48 weeks

• Incidence of serious adverse event (SAE)

  Phase 1

  48 weeks

• Temperature in ℃

  Phase 1

  48 weeks

• Pulse in BPM(Beat per Minute)

  Phase 1

  48 weeks

• Blood Pressure in mmHg

  Phase 1

  48 weeks

• Weight in Kg

  Phase 1

  48 weeks

• Height in centimeter

  Phase 1

  48 weeks

• Laboratory tests-Blood Routine examination

  Phase 1

  48 weeks

• Laboratory tests-Urine Routine test

  Phase 1

  48 weeks

• Laboratory tests-Blood biochemistry

  Phase 1

  48 weeks

• Laboratory tests- Coangulation function

  Phase 1

  48 weeks

• Echocardiography- LVEF(Left Ventricular Ejection Fraction) in percentage

  Phase 1

  48 weeks

• 12-lead electrocardiogram (ECG) in QTcF.

  Phase 1

  48 weeks

• 12-lead electrocardiogram (ECG) in QT.

  Phase 1

  48 weeks

• 12-lead electrocardiogram (ECG) in QRS.

  Phase 1

  48 weeks

• 12-lead electrocardiogram (ECG) in HR.

  Phase 1

  48 weeks

• 12-lead electrocardiogram (ECG) in RR.

  Phase 1

  48 weeks

• 12-lead electrocardiogram (ECG) in PR.

  Phase 1

  48 weeks

• ECOG(Eastern Cooperative Oncology Group) score

  Phase 1

  48 weeks

• Overall Response Rate (ORR)

  Phase 2

  64 weeks

Secondary Outcomes (30)

• Pharmacokinetic (PK) Parameter: Maximum Observed Concentration (Cmax)

  112 weeks

• PK Parameter:Time of Maximum Observed Concentration (Tmax)

  112 weeks

• PK Parameter: Area Under the Concentration-time Curve(AUC)

  112 weeks

• PK Parameter: Steady State Maximum Concentration(Cmax,ss)

  112 weeks

• PK Parameter: Steady State Minimum Concentration(Cmin,ss)

  112 weeks

Study Arms (3)

LM101 Dose Escalation

EXPERIMENTAL

Drug: LM101

LM101 combination therapy exploratory

EXPERIMENTAL

Drug: LM101; Drug: Toripalimab; Drug: Rituximab

LM101 combination expansion

EXPERIMENTAL

Drug: LM101; Drug: Toripalimab; Drug: Rituximab

Interventions

LM101 DRUG

Administered intravenously

LM101 Dose Escalation; LM101 combination expansion; LM101 combination therapy exploratory

Toripalimab DRUG

Administered intravenously

LM101 combination expansion; LM101 combination therapy exploratory

Rituximab DRUG

Administered intravenously

LM101 combination expansion; LM101 combination therapy exploratory

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure.
• Aged ≥18 years old, male or female.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Life expectancy ≥ 3 months.
• Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy.
• At least one evaluable lesion.
• Subjects in the combination therapy group must have Archived Samples or fresh tumor tissue specimens are required for testing.
• Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose:
• Women of childbearing potential (WOCBP) must agree to use highly effective methods of contraception prior to study entry, during the study and for 6 months after the last dose of study drug.
• Subjects who can communicate well with investigators and understand and adhere to the requirements of this study.

You may not qualify if:

• Subject has received prior investigational therapy directed at the same target therapy.
• Subjects has participated in any other interventional clinical trial within 21 days prior to the first dosing of LM-101.
• Subjects with anti-tumor treatment within 21 days prior to the first dosing of LM-101, including radiotherapy, chemotherapy, endocrine therapy, and immunotherapy, etc.
• Any adverse event from prior anti-tumor therapy has not yet recovered to ≤ grade 1 of CTCAE v5.0.
• Poorly controlled tumor-related pain.
• Subjects with symptomatic/active central nervous system (CNS) metastases.
• Subjects who have uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures.
• Subjects with known hypersensitivity to antibody therapy.
• Subjects who take systemic corticosteroids (\> 10 mg daily prednisone equivalents) or other systemic immunosuppressive medicationswithin 2 weeks prior to the first dosing of LM-101.
• Subjects with the known history of autoimmune disease with the exception of subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone.
• Subject who has interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
• Use of any live attenuated vaccines within 28 days prior to the first dosing of LM-101.
• Subjects who are using therapeutic doses of anticoagulants such as heparin or vitamin K antagonists.
• Subjects who received major surgery or interventional treatment within 28 days prior to the first dosing of LM-101 (excluding tumor biopsy, puncture, etc.).
• Subjects who have history of severe cardiovascular disease.

Sponsors & Collaborators

• LaNova Medicines Limited: lead

Study Sites (5)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

RECRUITING

Linyi Cancer Hospital

Linyi, Shandong, China

NOT YET RECRUITING

Beijing Tongren Hospital, CMU

Beijing, China

TERMINATED

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

toripalimab; Rituximab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Alex Yuan

CONTACT

+8615901815211; alexyuan@lanovamed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2022
• First Posted: November 14, 2022
• Study Start: January 11, 2023
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): January 11, 2028
• Last Updated: December 19, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)