What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as chemotherapy, targeted therapy, and immunotherapy, have distinct side effect profiles. Chemotherapy often causes myelosuppression, nausea, vomiting, alopecia, and fatigue. Targeted therapies can lead to hypertension, diarrhea, liver toxicity, and skin rashes. Immunotherapies may result in immune-related adverse events including colitis, dermatitis, hepatitis, and endocrinopathies. These side effects are likely relevant to treatments similar to those being studied in the LUNA18 trial.

What prior FDA approvals exist?

Several anti-cancer agents have received FDA approval for the treatment of solid tumors. For instance, cabozantinib (XL184), an oral tyrosine kinase inhibitor, has been approved for medullary thyroid cancer and has shown activity in other solid tumors. Pembrolizumab, an immune checkpoint inhibitor, is approved for various solid tumors, including melanoma and non-small cell lung cancer. Additionally, bevacizumab, an angiogenesis inhibitor, is approved for use in multiple solid tumors such as colorectal cancer and non-small cell lung cancer. These drugs have demonstrated significant efficacy in clinical trials, leading to their FDA approval for treating solid tumors.

What other types of research exist?

Promising novel alternatives to LUNA18 for solid tumor patients include: <ol> <li>ONC201: An investigational oral compound under active investigation for H3 K27-altered midline gliomas, showing potential in early trials.</li> <li></li> </ol> Regorafenib: A multitargeted kinase inhibitor with demonstrated activity in advanced osteosarcoma. 3. Venetoclax: An orally available BCL2 inhibitor effective in combination with low-dose cytarabine for AML, which may have potential in other solid tumors. 4. PD-1/PD-L1 inhibitors (e.g., Avelumab, Pembrolizumab): These have shown durable responses in various cancers, including mesothelioma and other solid tumors.

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LUNA18 for Solid Tumors

Phase 1

Recruiting

Research Sponsored by Chugai Pharmaceutical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years at time of signing informed consent form

Patients with a histologically or cytologically proven diagnosis of a locally advanced, recurrent, or metastatic incurable solid tumor for which standard therapy either does not exist or has proven ineffective or intolerable

Must not have

Patients with current severe, uncontrolled systemic disease (including, but not limited to, clinically significant cardiovascular disease, pulmonary disease, or renal disease, ongoing or active infection)

Patients with primary central nervous system (CNS) malignancy, untreated CNS metastases requiring any anti-tumor treatment, or active CNS metastases

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called LUNA18 to see if it can help treat advanced or spreading cancers. Researchers will look at how the drug moves through and affects the body, and whether it can help control or reduce tumors. The study includes patients whose cancer is difficult to treat with standard therapies.

Who is the study for?

Adults over 18 with advanced solid tumors not responding to standard treatments can join. They must be relatively healthy (ECOG status of 0 or 1) and have RAS mutation-positive tumors that are measurable. Those with serious heart conditions, uncontrolled diseases, lung complications like ILD, brain cancer, or active brain metastases needing treatment cannot participate.

What is being tested?

The study is testing LUNA18's safety and effectiveness alone or with other cancer drugs in patients with advanced solid tumors. It's a Phase 1 trial where doses increase gradually to find the right balance between safety and potential benefits.

What are the potential side effects?

Possible side effects include reactions related to Cetuximab such as skin rash, low magnesium levels, infusion-related symptoms; for LUNA18 specific side effects aren't listed but may align with typical cancer drug risks like nausea, fatigue, blood count changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is advanced, cannot be cured with surgery, and standard treatments haven't worked or I can't tolerate them.

Select...

I am fully active or can carry out light work.

Select...

My solid tumor is positive for RAS alterations.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any severe, uncontrolled illnesses like heart, lung, or kidney diseases.

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I have a brain tumor or cancer spread to my brain that needs treatment.

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I have a history of lung scarring or ILD.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible

This trial's timeline: 3 weeks for screening, Varies for treatment, and from screening until the time of clinical responses and/or the time of progressive disease (up to approximately 43 months), if feasible for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Area under the concentration versus time curve (AUC) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]

Maximum plasma concentration (Cmax) of LUNA18 when administered as a single agent [Part A, AA] and in combination with other anti-cancer drugs [Part D]

Phosphorylation level of ERK protein (pERK) in tumor tissues [Part B]

+5 more

Secondary study objectives

Anti-drug antibody to LUNA18[Part A, AA, B, C, D and E]

Phosphorylation level of ERK protein (pERK) in tumor tissues [Part A, AA, C, D, E]

Plasma concentrations of LUNA18 [Part B, C and E]

+2 more

Side effects data

From 2013 Phase 2 trial • 86 Patients • NCT01256385

75%

Fatigue

65%

Anemia

48%

Hyperglycemia

43%

Lymphocyte count decreased

38%

Anorexia

35%

Platelet count decreased

35%

Constipation

35%

Cough

35%

Nausea

30%

Pain

30%

Mucositis oral

28%

Dyspnea

28%

White blood cell decreased

28%

Hypoalbuminemia

25%

Alanine aminotransferase increased

25%

Cholesterol high

25%

Hypertriglyceridemia

23%

Dysphagia

20%

Depression

20%

Fever

20%

Hypophosphatemia

20%

Weight loss

18%

Alkaline phosphatase increased

18%

Non-cardiac chest pain

18%

Aspartate aminotransferase increased

18%

Insomnia

18%

Headache

18%

Hyponatremia

18%

Hypocalcemia

18%

Hypokalemia

15%

Edema face

15%

Vomiting

15%

Creatinine increased

15%

Neck pain

15%

Peripheral sensory neuropathy

13%

Infections and infestations - Other

13%

Diarrhea

13%

Dysgeusia

13%

Rash acneiform

13%

Rash maculo-papular

10%

Neutrophil count decreased

10%

Arthralgia

10%

Dizziness

10%

Edema limbs

Anxiety

Oral dysesthesia

Respiratory failure

Pneumonitis

Pruritus

Facial pain

Back pain

Dry mouth

Dry skin

Hypertension

INR increased

Neck edema

Allergic rhinitis

Pleural effusion

General disorders and administration site conditions - Other

Hypernatremia

Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other

Skin infection

Dyspepsia

Ear pain

Epistaxis

Gastroesophageal reflux disease

Generalized muscle weakness

Hypomagnesemia

Leukocytosis

Lung infection

Lymphedema

Sore throat

Tumor pain

Urinary frequency

Hearing impaired

Sinusitis

Chills

Dehydration

Hypercalcemia

Hyperkalemia

Myalgia

Papulopustular rash

Alopecia

Oral pain

Vertigo

Tracheostomy site bleeding

Pharyngeal hemorrhage

Laryngeal obstruction

Anorectal infection

Hypoxia

Pleural infection

Pleuritic pain

Pneumothorax

Respiratory, thoracic and mediastinal disorders - Other

Stridor

Postnasal drip

Skin and subcutaneous tissue disorders - Other

Skin ulceration

Eye disorders - Other

Heart failure

Tracheal hemorrhage

Blurred vision

Hypotension

Palmar-plantar erythrodysesthesia syndrome

Peripheral motor neuropathy

100%

80%

60%

40%

20%

Study treatment Arm

Arm B (Temsirolimus)

Arm A (Cetuximab and Temsirolimus)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Group I: Dose finding part (Part D)Experimental Treatment2 Interventions

Patients will receive LUNA18 capsule(s) in combination with cetuximab at finding doses

Group II: Dose escalation part (Part A)Experimental Treatment1 Intervention

Patients will receive LUNA18 capsule(s) at escalated doses

Group III: Cohort expansion part (Part E)Experimental Treatment2 Interventions

Patients will receive LUNA18 capsule(s) in combination with cetuximab at the recommended dose

Group IV: Cohort expansion part (Part C)Experimental Treatment1 Intervention

Patients will receive LUNA18 capsule(s) at the recommended dose

Group V: Biomarker part (Part B)Experimental Treatment1 Intervention

Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A

Group VI: Backfill part (Part AA)Experimental Treatment1 Intervention

Patients will receive LUNA18 capsule(s) at doses where the tolerability is confirmed in Part A

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cetuximab

2011

Completed Phase 3

~2480

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors include chemotherapy, which works by killing rapidly dividing cancer cells; targeted therapy, which blocks specific molecules involved in tumor growth and progression; and immunotherapy, which enhances the body's immune system to recognize and destroy cancer cells. Investigational agents like LUNA18, although not specified, likely function through one of these mechanisms or a novel approach. Understanding these mechanisms is crucial for solid tumor patients as it helps in selecting the most effective treatment, managing side effects, and improving overall outcomes.

Current status of molecular-targeted drugs for endometrial cancer (Review).