LM-302 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas M.D. Anderson Cancer Center, Houston, TX
Solid Tumors, Advanced Solid Tumors+1 More
LM-302 - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

Study of LaNova Medicines(LM)-302 in Patients With Advance Solid Tumors

See full description

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

This trial is evaluating whether LM-302 will improve 14 primary outcomes, 13 secondary outcomes, and 1 other outcome in patients with Solid Tumors, Advanced Solid Tumors. Measurement will happen over the course of Cycle 1 of each cohort. Duration of one cycle is 21 days.

Year 1
Change in Electrocardiogram (ECG)-(R wave)RR interval
Change in Electrocardiogram (ECG)-QRS duration
Change in Electrocardiogram (ECG)-QT interval
Change in Physical examination-weight
Change in Vital Signs-diastolic blood pressure
Change in Vital Signs-ear temperature
Change in Vital Signs-pulse rate
Change in Vital Signs-systolic pressure
Incidence of Abnormal Clinical Laboratory Test Results-Biochemistry
Incidence of Abnormal Clinical Laboratory Test Results-Coagulation test
Incidence of Abnormal Clinical Laboratory Test Results-Urinalysis
Incidence of Abnormal Clinical Laboratory Test Results-hematology
Day 21
Dose limiting toxicity (DLT)
Year 1
Number of participants with adverse events and serious adverse events
Up to 1 year
Area under the serum concentration versus time curve within one dosing interval (AUCtau)
Clearance (CL)
Disease control rate of LM-302.
Dose proportionality
Duration of response of LM-302.
Maximum serum concentration (Cmax)
Minimum serum concentration(Cmin)
Objective response rate of LM-302.
Progression-free survival of LM-302.
Terminal half-life (T1/2)
Time to reach maximum serum concentration (Tmax)
To assess the immunogenicity of LM-302;
Volume of distribution at steady state (Vss)
Up to 2 years
To explore the correlation between CLDN18.2 expression and anti-tumor activity of LM-302

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

6 Treatment Groups

LM302 Dose Escalation Level 4, 1.6mg/kg
1 of 6
LM302 Dose Escalation Level 1, 0.2 mg/kilogram(kg),
1 of 6
LM302 Dose Escalation Level 2, 0.4 mg/kg
1 of 6
LM302 Dose Escalation Level 6, 2.8mg/kg
1 of 6
LM302 Dose Escalation Level 3, 0.8 mg/kg
1 of 6
LM302 Dose Escalation Level 5, 2.4mg/kg
1 of 6
Experimental Treatment

This trial requires 42 total participants across 6 different treatment groups

This trial involves 6 different treatments. LM-302 is the primary treatment being studied. Participants will be divided into 6 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

LM302 Dose Escalation Level 4, 1.6mg/kg
Drug
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fourth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=6;
LM302 Dose Escalation Level 1, 0.2 mg/kilogram(kg),
Drug
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. first dose: 0.2mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=1;
LM302 Dose Escalation Level 2, 0.4 mg/kg
Drug
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. second dose: 0.4mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=3;
LM302 Dose Escalation Level 6, 2.8mg/kg
Drug
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. sixth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=12;
LM302 Dose Escalation Level 3, 0.8 mg/kg
Drug
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. third dose: 0.8mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=6;
LM302 Dose Escalation Level 5, 2.4mg/kg
Drug
The dose escalation scheme using the the accelerated titration design for dose 1 and the i3+3 design for the remaining doses. fifth dose: 1.6mg/kg i.v. every 3 weeks (1 cycle=21 days) , n=9;

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline c1d1through approximately 1 year after first administration of lm302
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly baseline c1d1through approximately 1 year after first administration of lm302 for reporting.

Closest Location

The University of Texas M.D. Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Solid Tumors, Advanced Solid Tumors or the other condition listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Subjects who are fully informed of the purpose, nature, method and possible adverse reactions of the study, and are willing to participate in the study and sign the informed consent form (ICF) prior to any procedure;
Claudin18.2(CLDN18.2) status will be tested by central immunohistochemistry (IHC) testing for the enrolled subjects if the archived tumor tissue samples are available, and the enrolment is not dependent on the CLDN18.2's status.
Gastric and gastroesophageal junction adenocarcinoma;
Biliary tract carcinoma;
Aged ≥18 years old when sign the ICF, male or female;
Life expectancy ≥ 3 months;
CLDN18.2 positive may be required for the high dose levels as determined by Safety Monitoring Committee(SMC), the subjects need to have CLDN 18.2 positive available before enrolled and dosed, and the tumor types are limited to the types listed as phase Ib (Dose expansion).
Pancreatic carcinoma;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, and no deterioration within 2 weeks prior to the first dose;
Phase Ⅰa (Dose Escalation): Subjects must have histological or cytological confirmation of recurrent or refractory advanced solid tumors, and have progressed on standard therapy, or are intolerable for available standard therapy , or there is no available standard therapy. The advanced solid tumors include but not limit to gastric and gastroesophageal junction adenocarcinoma, esophageal adenocarcinoma, pancreatic carcinoma, biliary tract carcinoma, colorectal carcinoma, ovarian carcinoma.

Patient Q&A Section

What is lm-302?

"In summary, LM-302 is a new oncology drug candidate that selectively targets and destroys tumor cells. As a small-molecule, it possesses interesting anti-proliferative and anti-metastatic properties, which could increase clinical therapeutic benefit of LM-302 as a novel chemotherapy agent for multiple cancers." - Anonymous Online Contributor

Unverified Answer

Has lm-302 proven to be more effective than a placebo?

"Results of this first-in-human assessment of LM-302 show that lm-302 has measurable antimitotic and proapoptotic properties, and demonstrates activity against advanced cancer in patients with solid tumors. The findings provide proof-of-concept that in conjunction with our targeted and personalized tumor immunotherapy strategies, targeting cell division through antimitotic or apoptotic mechanisms will be highly effective in treating advanced cancer." - Anonymous Online Contributor

Unverified Answer

What causes solid tumors, advanced solid tumors?

"Solid tumors are often treated using medical imaging or ultrasound for visualization of the tumor in order to gain access. This technique provides treatment options for patients with tumors located in remote sites, while also allowing for a more precise targeting of the tumor and the surrounding tissue. There are significant disadvantages, including the risks of tumor manipulation, cancer cell dissemination and toxicity if the imaging or ultrasound technique is used. In many cases, patients become resistant to the treatment because of the low concentration and penetration of the chemotherapy drugs inside the growing solid tumor. Because imaging or ultrasound techniques cannot provide the desired levels of drug penetration, new ways of target solid lesions and tumours are desired, i.e. targeted therapy to enhance drug distribution inside the cancer." - Anonymous Online Contributor

Unverified Answer

What are common treatments for solid tumors, advanced solid tumors?

"In the United States, treatments typically involve a combination of surgery, radiation, and chemotherapy, in addition to targeted medications. Survival rates for locally advanced solid tumors are improving, most likely because of advances in surgery. Survival rates for metastatic patients is generally poor: in 2004, only 5% had a median survival of more than 5 years." - Anonymous Online Contributor

Unverified Answer

Can solid tumors, advanced solid tumors be cured?

"Cancer treatment can result in cure of a subset of patients with a good quality of life. However, a large proportion of patients will still have a low quality of life and a limited number of anticancer drugs that can offer significant results." - Anonymous Online Contributor

Unverified Answer

What is solid tumors, advanced solid tumors?

"Solid tumors are tumors that do not have a liquid or solid component in them. They may be metastatic or non-metastatic. They are differentiated or undifferentiated. Usually they are benign or malignant tumors. Advanced solid tumors are cancers that have spread to other parts of the body. A solid tumor that has not spread is called a primary or isolated solid tumor. They are differentiated or undifferentiated. Solid tumors may show tumors with different types of tissue differentiation, or differentiation. They may be benign or malignant. Usually they are benign or malignant tumors." - Anonymous Online Contributor

Unverified Answer

How many people get solid tumors, advanced solid tumors a year in the United States?

"The number of people with cancers of the colon, lung or stomach grew by more than 40% from 1980 to 2010. The number of people with solid tumors, lung cancers, and advanced solid tumors grew by more than 70% from 1980 to 2010. The number of people diagnosed with advanced solid tumors continued to decline from 2010 to 2015." - Anonymous Online Contributor

Unverified Answer

What are the signs of solid tumors, advanced solid tumors?

"Sudden onset of a new persistent, nonreducible mass in the lower abdominal or pelvic region are common signs of advanced solid tumors. Painful masses and abdominal mass, pelvic pain, constipation and weakness may also be manifested." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for solid tumors, advanced solid tumors?

"Recent findings identified important clinical characteristics that may allow us to assess the propensity for clinical trial candidates to enroll in trial. Patients who presented clinically for treatment other than chemotherapy had markedly different outcomes in that trial." - Anonymous Online Contributor

Unverified Answer

How does lm-302 work?

"Results from a recent clinical trial of this study illustrate that the novel anti-tumor efficacy of LM-302, which is independent of the AKT pathway, can be explained by the potentiation of the autophagic cell death mediated by activation of the p70S6K/RPS6 pathway. Therefore, combination of the anti-tumor activity mediated by cIAP2 inhibition with the autophagy augmentation may provide an effective adjuvant therapy for patients with solid tumors." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets solid tumors, advanced solid tumors?

"Solid cancers that affect people less than 55 and over age 75 account for 10% and 29% of all new cases and deaths from solid cancers in the United States, respectively. People over the age of 75 are less likely than those under the age of 55 to receive medical attention for symptoms indicating cancer. These factors need to be taken into account for a full understanding of the impact of solid cancers on society." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving lm-302?

"Lm-302 is in phase IIa clinical trials for solid tumors. Lm-302 has a dual mechanism of action: an inhibitor of aldehyde dehydrogenase 1 and a pro-adrenaline receptor agonist, thus it may be able to selectively kill tumor cells by inhibiting the metabolism of a variety of pro-malignant and pro-inflammatory compounds." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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