What side effects are associated with this type of intervention?

Common treatments for colorectal cancer, such as fluoropyrimidine-based chemotherapy, oxaliplatin-based regimens, and cetuximab, have several known side effects. Fluoropyrimidine-based chemotherapy can cause gastrointestinal symptoms like nausea, vomiting, diarrhea, and mucositis, as well as myelosuppression leading to anemia, leukopenia, and thrombocytopenia. Oxaliplatin-based regimens often result in peripheral neuropathy, which can be acute or chronic, along with similar gastrointestinal and hematologic toxicities. Cetuximab, an epidermal growth factor receptor inhibitor, can cause skin reactions, including acneiform rash, as well as infusion-related reactions, hypomagnesemia, and, less commonly, sepsis. These side effects can significantly impact the patient's quality of life and may require dose adjustments or discontinuation of therapy.

What prior FDA approvals exist?

Several FDA-approved drugs have demonstrated anti-tumor properties in the treatment of colorectal cancer. These include chemotherapeutic agents such as fluorouracil, leucovorin, oxaliplatin, and irinotecan, which are often used in combination regimens like FOLFOX and FOLFIRI. Targeted therapies such as bevacizumab, an anti-VEGF monoclonal antibody, and cetuximab, an anti-EGFR monoclonal antibody, have also been approved for use in metastatic colorectal cancer. These treatments aim to inhibit tumor growth and progression, similar to the investigational drug SM08502 being studied for its anti-tumor efficacy in advanced solid tumors.

What other types of research exist?

Promising novel alternatives to SM08502 for colorectal cancer patients include NK012, a polymeric micelle formulation of SN-38, which has shown efficacy in patients with unresectable metastatic colorectal cancer. Additionally, targeting the VEGF pathway with agents like bevacizumab has demonstrated activity in advanced colorectal cancer. These alternatives offer potential anti-tumor benefits and should be considered in consultation with a healthcare provider.

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Other

SM08502 + Standard Treatments for Advanced 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 no uncontrolled intercurrent illness

Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1

Must not have

Subjects with untreated, progressing, or known symptomatic brain metastasis

Subjects with active infection

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called SM08502, taken by mouth, in adults with advanced solid tumors. The goal is to see if it helps other cancer treatments work better. The drug is taken for several days with short breaks in between.

Who is the study for?

Adults with advanced solid tumors like colorectal, lung, or prostate cancer can join this trial. They should be in good health otherwise, have a life expectancy over 3 months, and not have severe side effects from past treatments. Participants need to be able to take pills and agree to use birth control.

What is being tested?

The trial is testing SM08502 taken orally with standard hormonal therapy or chemotherapy for treating advanced cancers. It's an open-label study where everyone knows what treatment they're getting. The dose may change as the study goes on.

What are the potential side effects?

Possible side effects include those typical of chemotherapy such as nausea, fatigue, hair loss; hormonal therapy might cause hot flashes or mood swings; and SM08502 could potentially cause digestive issues or affect how other drugs work.

Eligibility Criteria

Inclusion Criteria

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

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I do not have any untreated or uncontrolled health conditions.

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I am fully active or can carry out light work.

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I have advanced cancer confirmed by lab tests.

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I can swallow and keep down pills.

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 hasn't been treated or is getting worse.

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I currently have an active infection.

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I have had a heart attack in the last year, heart failure, or serious heart disease.

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My heart's electrical cycle is longer than normal.

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I am not pregnant or breastfeeding.

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I have received an organ transplant.

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I have a serious heart condition.

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 5 years

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

Treatment Details

Study Objectives

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

Primary study objectives

Part 1 - Blood samples for measurement of the plasma levels of SM08502 and its metabolite

Part 1 - Incidence of Treatment Emergent Adverse Events (TEAEs)

Part 1 - Maximum tolerated dose (MTD) of SM08502 when combined with standard of care agents.

+3 more

Secondary study objectives

Part 1 - Objective Response rate

Part 2 - Blood samples for measurement of the plasma levels of SM08502 and its metabolite

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: NSCLC (Non-Small Cell Lung Cancer) - SM08502 + DocetaxelExperimental Treatment2 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced NSCLC. Subjects will receive increasing doses of SM08502 with fixed doses of docetaxel to determine the MTD and recommended Part 2 dose and schedule. Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM0850 in subjects with advanced NSCLC. Approximately 20 subjects will be enrolled.

Group II: CRPC (Castration Resistant Prostate Cancer) - SM08502 + Abiraterone/PrednisoneExperimental Treatment3 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced CRPC. Subjects will receive increasing doses of SM08502 with fixed doses of Abiraterone/Prednisone to determine the MTD and recommended Part 2 dose and schedule. Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM08502 in subjects with advanced CRPC. Approximately 20 subjects will be enrolled.

Group III: CRC (Colorectal Cancer) - SM08502 + FOLFIRI/PanitumumabExperimental Treatment3 Interventions

Part 1 (dose escalation cohorts) will evaluate SM08502 in subjects with advanced CRC. Subjects will receive increasing doses of SM08502 with fixed doses of FOLFIRI plus panitumumab ( RAS wild type tumors) or with fixed doses of FOLFIRI (RAS mutant tumors) Escalation will follow a 3+3+3 design within each cohort. Part 2 will further evaluate the recommended dose and schedule of SM08502. Subjects that have RAS wild type tumors will receive FOLFIRI and panitumumab with SM08502 (n=15). Subjects that have RAS mutant tumors will receive FOLFIRI with SM08502 (n=15).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Abiraterone

2012

Completed Phase 4

~4480

Docetaxel

1995

Completed Phase 4

~6550

Panitumumab

2017

Completed Phase 3

~7150

FOLFIRI Protocol

2014

Completed Phase 2

~50

Prednisone

2014

Completed Phase 4

~2500

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

Common treatments for colorectal cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy, such as fluoropyrimidine-based regimens, works by interfering with DNA synthesis and cell division, leading to cancer cell death. Targeted therapies, like cetuximab and bevacizumab, inhibit specific molecules involved in tumor growth and angiogenesis, respectively. Immunotherapy, including checkpoint inhibitors, enhances the immune system's ability to recognize and destroy cancer cells. These mechanisms are crucial for colorectal cancer patients as they directly target the cancer cells' ability to grow and spread, improving treatment efficacy and patient outcomes. The trial of SM08502, which explores its anti-tumor properties in combination with chemotherapy or hormonal therapy, aims to enhance these effects by potentially offering a novel mechanism to inhibit tumor progression.

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