What side effects are associated with this type of intervention?

Common treatments for cancer similar to RBS2418, which include immune modulators and checkpoint inhibitors like pembrolizumab, often have side effects such as fatigue, diarrhea, skin rash, and pruritus. Severe adverse events can include pneumonitis, colitis, hepatitis, and endocrinopathies. These treatments can also lead to immune-related adverse events requiring management with steroids or other immunosuppressive agents.

What prior FDA approvals exist?

The FDA has approved several immune modulators and checkpoint inhibitors for cancer treatment. Pembrolizumab, an anti-PD-1 antibody, is approved for various cancers, including melanoma and non-small cell lung cancer. Other similar drugs include nivolumab (another anti-PD-1 antibody) and ipilimumab (an anti-CTLA-4 antibody). These drugs work by enhancing the body's immune response against cancer cells. Additionally, PARP inhibitors like olaparib and rucaparib have been approved for cancers with specific genetic mutations, such as BRCA mutations in ovarian and prostate cancers. These treatments represent a broader category of immune and targeted therapies that aim to improve anti-tumor immunity.

What other types of research exist?

<ol> <li>Entrectinib: A tumor-agnostic drug effective in cancers with NTRK fusion mutations, such as cholangiocarcinoma.</li> </ol> It has shown clinical improvement and manageable side effects in patients with advanced cancers. 2. Alpelisib + Fulvestrant: This combination has demonstrated improved progression-free survival in HR+, HER2-, PIK3CA-mutated breast cancer. 3. ONC201: A selective DRD2 antagonist showing promise in H3K27M-mutated diffuse midline gliomas and recurrent glioblastoma. 4. Niraparib: A PARP inhibitor effective in metastatic castration-resistant prostate cancer (CRPC) with BRCA1/2 mutations. 5. Checkpoint Inhibitors: These have shown efficacy in various cancers, including advanced non-small cell lung cancer and melanoma, with ongoing studies comparing their effectiveness in real-world settings.

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Immune Modulator

RBS2418 for Cancer

Phase 1

Recruiting

Research Sponsored by Riboscience, LLC.

Eligibility Criteria Checklist

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

Must have

Have a performance status of 0, 1 or 2 using the ECOG Performance Scale within 14 days of first dose of study drug

Be 18 years of age on day of signing informed consent

Must not have

Received a live, attenuated vaccine within 28 days prior to enrollment/cohort assignment or anticipation that such a live attenuated vaccine will be required during the trial

History or any evidence of interstitial lung disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 days from last dose

Awards & highlights

Summary

This trial is testing a new drug called RBS2418, alone or with pembrolizumab, for patients with advanced tumors who haven't responded to other treatments. The drug works by boosting the body's natural defenses to better recognize and destroy cancer cells.

Who is the study for?

Adults with advanced, inoperable or metastatic tumors who've tried all standard treatments without success can join. They must have a life expectancy of at least 3 months, be able to perform daily activities (with some limitations), and provide consent. Pregnant women are excluded, as well as those with severe allergies to certain drugs or uncontrolled cancer symptoms.

What is being tested?

RBS2418 is being tested for its ability to boost the body's immune response against tumors by affecting cellular compounds like cGAMP and ATP. This trial will explore RBS2418 alone or combined with pembrolizumab in patients whose cancers haven't responded to standard care.

What are the potential side effects?

Potential side effects may include reactions related to immune system activation such as inflammation in various organs, infusion-related responses, fatigue, digestive issues, blood abnormalities and increased risk of infections.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself and am up and about more than 50% of my waking hours.

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I am at least 18 years old.

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My cancer cannot be removed by surgery and has spread.

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I've had all standard treatments for my advanced cancer and there are no other options left.

Exclusion Criteria

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

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I have not received a live vaccine in the last 28 days and do not plan to during the trial.

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I have a history of lung scarring or damage.

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I have been treated for an autoimmune disease in the last 2 years.

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I haven't had any other cancers in the last 3 years.

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I have pain from my cancer that isn't relieved by treatment.

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I am on treatment for active HIV or my HIV is not under control.

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I am allergic to certain medications made in Chinese hamster ovary cells.

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I haven't had cancer treatment in the last 2 weeks.

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I frequently need procedures to remove excess fluid from my chest or abdomen.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 0 - 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 0 - 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 0 - 5 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 plasma concentration versus time curve (AUC)

Half-life (t1/2)

Number of participants with treatment emergent Adverse events

+3 more

Secondary study objectives

Overall response rate (ORR) by RECIST

Side effects data

From 2022 Phase 1 & 2 trial • 35 Patients • NCT03003468

40%

FATIGUE

37%

INFUSION RELATED REACTION

37%

NAUSEA

23%

DIARRHEA

23%

BACK PAIN

23%

ABDOMINAL PAIN

23%

ANOREXIA

20%

ARTHRALGIA

20%

COUGH

20%

NON-CARDIAC CHEST PAIN

17%

DYSPNEA

17%

CONSTIPATION

17%

CHILLS

17%

MYALGIA

13%

DIZZINESS

13%

HEADACHE

13%

PRURITUS

13%

RASH MACULO-PAPULAR

10%

ANEMIA

10%

URTICARIA

10%

SINUS TACHYCARDIA

10%

RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS - OTHER, SPECIFY

10%

EDEMA LIMBS

10%

ALLERGIC REACTION

10%

ANXIETY

10%

LUNG INFECTION

10%

SKIN AND SUBCUTANEOUS TISSUE DISORDERS - OTHER, SPECIFY

TUMOR PAIN

EAR AND LABYRINTH DISORDERS - OTHER, SPECIFY

HYPERGLYCEMIA

PAIN

PELVIC PAIN

PRODUCTIVE COUGH

PLEURAL EFFUSION

VOICE ALTERATION

VOMITING

FEVER

FLATULENCE

CREATININE INCREASED

HYPERTHYROIDISM

NECK PAIN

DEPRESSION

FLU LIKE SYMPTOMS

LYMPHOCYTE COUNT DECREASED

DYSPEPSIA

FLUSHING

HYPONATREMIA

HYPOTHYROIDISM

URINARY TRACT INFECTION

MUSCLE WEAKNESS LOWER LIMB

ALKALINE PHOSPHATASE INCREASED

DYSPHAGIA

ESOPHAGITIS

GASTROESOPHAGEAL REFLUX DISEASE

OSTEONECROSIS OF JAW

BRONCHOSPASM

PNEUMONITIS

SORE THROAT

BLURRED VISION

GAIT DISTURBANCE

HEMORRHOIDS

POSTNASAL DRIP

PRESYNCOPE

ACUTE KIDNEY INJURY

PERIPHERAL MOTOR NEUROPATHY

DRY SKIN

FLASHING LIGHTS

HYPOMAGNESEMIA

HYPERTENSION

HYPOTENSION

SINUSITIS

SYNCOPE

HEARING IMPAIRED

RASH ACNEIFORM

SOMNOLENCE

COLITIS

HOT FLASHES

RESPIRATORY FAILURE

CONJUNCTIVITIS

MOVEMENTS INVOLUNTARY

NASAL CONGESTION

PARESTHESIA

VAGINAL INFECTION

GASTROINTESTINAL DISORDERS - OTHER, SPECIFY

NEUTROPHIL COUNT DECREASED

ALLERGIC RHINITIS

PAIN IN EXTREMITY

SEPSIS

BLOATING

DEHYDRATION

DRY MOUTH

INSOMNIA

MALAISE

PAIN OF SKIN

THROMBOEMBOLIC EVENT

TREMOR

WEIGHT GAIN

100%

80%

60%

40%

20%

Study treatment Arm

Imprime PGG 4 mg/kg

Imprime PGG 2 mg/kg

Trial Design

3Treatment groups

Experimental Treatment

Group I: Treatment Group BExperimental Treatment1 Intervention

After dose escalation phase is completed in both monotherapy and combination therapy setting (A-1 and A-2), an expansion treatment group will be enrolled, and subjects (n=20- 40) will be treated with a fixed dose of RBS2418 to be selected by the Sponsor in consultation with the SRC and after reviewing the totality of the dose escalation data both as monotherapy and combination therapy.

Group II: Treatment Group A-2Experimental Treatment1 Intervention

For Treatment Group A-2, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418 in combination with pembrolizumab 200 mg IV (administered on Day 1 and every 3 weeks). Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID

Group III: Treatment Group A-1Experimental Treatment1 Intervention

For Treatment Group A-1, a cohort of three (3) subjects will be dosed at the starting dose of 100 mg twice a day (BID) of RBS2418. Subsequent subjects will then be enrolled in serial, three (3) subject cohorts, with 100% dose increments (doubling the dose) until 800 mg BID

0 / 13Eligibility 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

Cancer treatments work through various mechanisms to target and destroy cancer cells. Selective ENPP1 inhibitors like RBS2418 enhance anti-tumor immunity by increasing levels of cGAMP and ATP while reducing adenosine production, which helps activate immune responses against tumors. Other common treatments include chemotherapy, which kills rapidly dividing cells; targeted therapy, which blocks specific molecules involved in cancer growth and progression; immunotherapy, which boosts the body's immune system to fight cancer; and radiation therapy, which uses high-energy particles to destroy cancer cells. Understanding these mechanisms is crucial for cancer patients as it helps tailor treatments to their specific cancer type and improve outcomes by targeting the disease more effectively.

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