What side effects are associated with this type of intervention?

Common treatments for solid tumors, such as gemcitabine combined with nab-paclitaxel, often result in side effects like neutropenia, fatigue, neuropathy, and diarrhea. Taxane-based chemotherapies can cause alopecia, scalp pain, and headaches. Immunotherapies, including PD-1 inhibitors like nivolumab, may lead to immune-related adverse events such as fatigue, diarrhea, and infusion-related reactions. These side effects vary in severity and frequency but are important considerations in the management of solid tumors.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of solid tumors due to their anti-tumor activity. Pembrolizumab, an anti-PD-1 therapy, has been approved for various cancers including metastatic melanoma and non-small cell lung cancer. Nivolumab, another anti-PD-1 therapy, is approved for cancers such as renal cell carcinoma and small cell lung cancer. Additionally, the combination of nivolumab and ipilimumab, an anti-CTLA-4 therapy, has shown efficacy in treating metastatic melanoma. These immunotherapies work by enhancing the body's immune response against tumor cells, similar to the investigational drug SM08502 being studied for its anti-tumor activity in advanced solid tumors.

What other types of research exist?

Promising novel alternatives to SM08502 for solid tumor treatment include: 1) Infigratinib (BGJ398), an FGFR-selective tyrosine kinase inhibitor, which has shown efficacy in advanced cholangiocarcinoma with FGFR2 gene fusions. 2) Futibatinib, another FGFR inhibitor, which has received accelerated approval for cholangiocarcinoma. 3) Cabozantinib, which has demonstrated activity in advanced osteosarcoma. 4) Alectinib and Ceritinib, which are effective in ALK-positive non-small-cell lung cancer. These therapies have shown promising results in clinical trials and could be considered as alternatives for solid tumor patients.

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SM08502 for Cancer

Phase 1

Waitlist Available

Research Sponsored by Biosplice Therapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Subjects must have archived tumor specimens available for analysis or a fresh tumor biopsy will be required at study entry

Subjects with advanced solid tumors who are refractory to or intolerant of established therapy known to provide clinical benefit for their condition

Must not have

Subjects with untreated, progressing, or known symptomatic brain metastasis

Subjects with clinically significant ventricular tachycardia (VT), atrial fibrillation (AF), ventricular fibrillation (VF), second or third degree heart block

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

A Study Evaluating the Safety and Pharmacokinetics of Orally Administered SM08502 in Subjects With Advanced Solid Tumors

Who is the study for?

Adults with advanced solid tumors that have no standard treatment options can join. They must have measurable disease, be in good physical condition (ECOG ≤ 1), and have recovered from past treatments. A tumor sample for analysis is needed, and they shouldn't be pregnant or breastfeeding, nor should they have heart issues, severe liver problems, active infections requiring IV antibiotics, certain viral infections like HIV/HBV/HCV, or specific eye diseases.

What is being tested?

The trial tests SM08502 taken orally by patients with advanced solid tumors to check its safety and how the body processes it. It's an open-label study where everyone knows what treatment they're getting. The drug is given daily in cycles of 28 days to see if it helps shrink the tumors.

What are the potential side effects?

While not explicitly listed here, potential side effects may include typical reactions to cancer medications such as nausea, fatigue, digestive issues due to oral administration affecting absorption or metabolism of the drug; also possible are changes in blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

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

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I can provide a sample of my tumor for the study.

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My advanced cancer hasn't responded to or I can't tolerate standard treatments.

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I am fully active or have some restrictions but can still care for myself.

Exclusion Criteria

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

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I have brain metastasis that is untreated, getting worse, or causing symptoms.

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I have a serious heart rhythm problem.

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I have received an organ transplant.

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I have been diagnosed with osteoporosis.

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I have a retinal condition like diabetic retinopathy or macular degeneration.

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I have an active HIV, HBV, or HCV infection.

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I am not pregnant or breastfeeding.

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I haven't had a heart attack in the last year and don't have severe heart failure or significant heart disease.

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My liver is not working well (Child-Pugh B or C).

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I am a man who can father children and agree to follow contraceptive guidelines.

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I am currently on IV antibiotics for an infection.

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I do not have a GI condition that affects medication absorption.

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My heart's electrical system has a slight irregularity.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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

Trial Design

3Treatment groups

Experimental Treatment

Group I: Part 2: ExpansionExperimental Treatment1 Intervention

Part 2 will evaluate the recommended Part 2 dose and schedule of SM08502, as determined in Part 1B, in 3 cohorts of subjects. The indications to be evaluated include subjects with advanced and/or metastatic CRPC (two biomarker selection cohorts) and NSCLC for which histologic or cytologic confirmation of malignancy was obtained at diagnosis. Each cohort will enroll up to 20 subjects. Approximately 10 subjects of the total enrolled in Part 2, irrespective of cohort, will be included in a food-effect substudy to assess the preliminary effect of a high-fat, high-calorie meal on the PK of SM08502.

Group II: Part 1B: Dose FindingExperimental Treatment1 Intervention

Indications eligible for Part 1B include castration-resistant prostate cancer (CRPC), non-small cell lung cancer (NSCLC), triple-negative breast cancer (TNBC), colorectal cancer (CRC), endometrial cancer, or ovarian cancer for which histologic or cytologic confirmation of malignancy was obtained at diagnosis. Initially, two cohorts of 6-24 subjects will be evaluated comparing 2 different doses and schedules of SM08502 (30 mg daily and 40 mg 5 days on and 2 days off), administered orally following 28-day treatment cycles. If appropriate, alternative doses and schedules may be evaluated depending on the results.

Group III: Part 1A: Dose EscalationExperimental Treatment1 Intervention

Cohorts of subjects with advanced solid tumors will receive increasing doses (10, 20, 40, 60, 80, 120, 160, or 200 mg) of SM08502, administered orally, once daily, following 28-day treatment cycles. If the maximum tolerated dose (MTD) is not determined at the 200 mg dose, dosing will continue at 50 mg/dose increments until an MTD is determined. Cohorts will include approximately 1 to 6 subjects according to an accelerated escalation design and safety requirements for expansion of subject numbers. For the purpose of dose escalation and de-escalation, the dose of SM08502 and regimen may be modified based on the type of dose limiting toxicities (DLTs) observed and following data review and discussions between the Sponsor and Investigators.

0 / 16Eligibility 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 targeted therapies, chemotherapy, and immunotherapy. Targeted therapies, like SM08502, often inhibit specific molecules involved in tumor growth and survival, such as kinases or growth factor receptors, thereby blocking the signaling pathways that promote cancer cell proliferation. Chemotherapy works by killing rapidly dividing cells, including cancer cells, but can also affect normal cells, leading to side effects. Immunotherapy boosts the body's immune system to recognize and destroy cancer cells, often by targeting immune checkpoints. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment based on the tumor's specific characteristics and can provide insights into potential side effects and the expected efficacy of the treatment.