What side effects are associated with this type of intervention?

Common treatments for solid tumors, particularly those involving immune checkpoint inhibitors like pembrolizumab, often result in side effects such as fatigue, rash, pruritus, diarrhea, and pneumonitis. Severe immune-related adverse events can include colitis, hepatitis, endocrinopathies, and nephritis. The investigational agent CLN-619, while not specifically detailed, may share similar immune-related side effects.

What prior FDA approvals exist?

Pembrolizumab, an anti-PD-1 therapy, has received FDA approval for the treatment of multiple solid tumors, including melanoma, non-small cell lung cancer, head and neck squamous cell carcinoma, and others. Other similar immune checkpoint inhibitors include nivolumab (anti-PD-1) and atezolizumab (anti-PD-L1), which have also been approved for various solid tumors. These therapies work by enhancing the immune system's ability to recognize and attack cancer cells. The combination of immune checkpoint inhibitors with other treatments, such as chemotherapy or targeted therapies, has shown promising results and led to several FDA approvals.

What other types of research exist?

Promising alternatives to CLN-619 for solid tumor patients include: 1) Pembrolizumab, an immune checkpoint inhibitor, often used in combination with other therapies. 2) ONO/GS-4059, a selective BTK inhibitor, which may offer advantages in combination therapies for B-cell malignancies. 3) Venetoclax, particularly in combination with other agents like azacitidine, showing efficacy in hematologic malignancies but potentially applicable to solid tumors. 4) ONC201, a selective DRD2 antagonist, under investigation for gliomas and other solid tumors. 5) Nivolumab and ipilimumab, immune checkpoint inhibitors, showing promise in various solid tumors including mesothelioma and head and neck cancers.

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CLN-619 + Pembrolizumab for Cancer

Phase 1

Recruiting

Research Sponsored by Cullinan Therapeutics Inc.

Eligibility Criteria Checklist

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

Must have

Adequate liver and kidney function and hematological parameters within a normal range

Module A Monotherapy Dose Escalation Cohort and Module B Combination Therapy Dose Escalation Cohorts: Histologically or cytologically-confirmed metastatic or locally advanced, unresectable solid tumors. For Module B, tumor type is listed as an approved indication per the current prescribing information for pembrolizumab.

Must not have

Active SARS-CoV-2 infection

Active central nervous system metastases and/or carcinomatous meningitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CLN-619 alone and with pembrolizumab in patients with advanced solid tumors. These patients may not have other treatment options. Pembrolizumab helps the immune system fight cancer, and they are seeing if CLN-619 can help too.

Who is the study for?

Adults with advanced solid tumors, including specific types such as NSCLC, cervical cancer, HNSCC, and urothelial carcinoma. Participants must have measurable disease, acceptable organ function and performance status. Prior treatments are specified for each cohort. Pregnant or breastfeeding women and those unwilling to prevent pregnancy or donate sperm during the study are excluded.

What is being tested?

The trial is testing CLN-619 alone and combined with Pembrolizumab in patients with various advanced solid tumors. It's an early-phase (Phase 1), open-label study which means both researchers and participants know what treatment is being given.

What are the potential side effects?

Potential side effects may include typical reactions associated with immunotherapy such as inflammation of organs, infusion-related reactions, fatigue, possible immune system complications like pneumonitis or colitis, liver issues meeting Hy's Law criteria.

Eligibility Criteria

Inclusion Criteria

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

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My liver, kidneys, and blood counts are healthy.

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My cancer is advanced, cannot be surgically removed, and for Module B, it's a type treatable with pembrolizumab.

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My lung cancer is advanced and cannot be removed with surgery.

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Side effects from my previous cancer treatment are mild now.

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My bladder cancer cannot be removed by surgery and has spread.

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My head or neck cancer cannot be removed by surgery and has spread.

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My NSCLC worsened after treatment with specific immune therapies or targeted therapies for EGFR or ALK mutations.

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My lung cancer is advanced and cannot be removed with surgery.

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My cervical cancer is advanced and cannot be removed with surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

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

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I am currently infected with COVID-19.

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My cancer has spread to my brain or its coverings.

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I have more than one type of cancer.

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I've had severe side effects from immunotherapy, including nerve, eye, lung, heart, or colon issues, or serious liver problems.

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I have HIV or have tested positive for it.

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I have had hepatitis B or C in the past.

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I am not incapacitated or involuntarily incarcerated.

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I can follow the study plan and attend all required check-ups.

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I have had an organ or bone marrow transplant from another person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 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

Dose Escalation: TEAEs

Dose Expansion: Best Overall Response (BOR)

Dose Expansion: Clinical Benefit Rate (CBR)

+4 more

Secondary study objectives

All Cohorts: AUC

All Cohorts: Clast

All Cohorts: Cmax

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Module B Combination Therapy Dose EscalationExperimental Treatment2 Interventions

Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619 in combination with pembrolizumab

Group II: Module B Combination Therapy Cohort ExpansionExperimental Treatment2 Interventions

Patients with select tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module B Escalation arm, in combination with pembrolizumab

Group III: Module A Dose EscalationExperimental Treatment1 Intervention

Patients with advanced solid tumors enrolled in dose escalation cohorts treated with CLN-619

Group IV: Module A Cohort ExpansionExperimental Treatment1 Intervention

Patients with select solid tumor types enrolled in expansion cohorts treated with CLN-619 at a dose selected from the Module A Escalation arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3130

0 / 19Eligibility 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 immunotherapy, chemotherapy, and targeted therapy. Immunotherapy, such as pembrolizumab, works by stimulating the patient's immune system to recognize and attack cancer cells. Chemotherapy uses cytotoxic drugs to kill rapidly dividing cells, including cancer cells, but can also affect healthy cells. Targeted therapy involves drugs designed to target specific molecules involved in cancer cell growth and survival, minimizing damage to normal cells. Understanding these mechanisms is crucial for patients as it helps in selecting the most appropriate treatment, managing expectations, and anticipating potential side effects. For instance, the combination of CLN-619 with pembrolizumab in the trial aims to enhance the immune response against tumors, potentially offering a more effective treatment option for patients with advanced solid tumors.