What side effects are associated with this type of intervention?

Common treatments for solid tumors, including immunotherapies and chemotherapies, often have a range of side effects. For immunotherapies like durvalumab, common adverse events include pneumonia, diarrhea, pneumonitis, rash, and pruritus. Chemotherapies such as those involving gemcitabine and pemetrexed can cause significant hematologic toxicity, including neutropenia, febrile neutropenia, and anemia, as well as non-hematologic toxicities like fatigue, constipation, vomiting, and dehydration. These treatments are generally evaluated for their safety, tolerability, anti-cancer effects, and how they are processed by the body (pharmacokinetics).

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of solid tumors, focusing on safety, tolerability, anti-cancer effects, and pharmacokinetics. For instance, pembrolizumab and nivolumab are immune checkpoint inhibitors approved for various solid tumors, including melanoma and renal cell carcinoma, based on their demonstrated efficacy and manageable safety profiles. Additionally, targeted therapies like erlotinib and gefitinib, which inhibit specific tyrosine kinases, have been approved for non-small cell lung cancer. These approvals were based on comprehensive clinical trials assessing their pharmacokinetics, safety, and anti-cancer efficacy, similar to the ongoing studies for KD033 (SAR445710).

What other types of research exist?

Promising alternatives to KD033 (SAR445710) for solid tumor patients include: 1) Regorafenib, which has shown activity in advanced osteosarcoma and other solid tumors with a manageable safety profile. 2) Cabozantinib, which targets multiple kinases and has demonstrated efficacy in advanced Ewing sarcoma and osteosarcoma. 3) Niraparib, a PARP inhibitor with activity in prostate cancer patients with BRCA mutations, showing potential for broader application in solid tumors. These alternatives have shown promising results in terms of safety, tolerability, anti-cancer effects, and pharmacokinetics in clinical trials.

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Monoclonal Antibodies

KD033 for Advanced Cancer

Phase 1

Waitlist Available

Research Sponsored by Kadmon Corporation, LLC

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an expected average of 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial tests KD033 (SAR445710), an experimental drug, in adults with advanced or spreading solid tumors. It aims to see if the drug is safe, effective, and how the body processes it.

Who is the study for?

This trial is for adults with advanced or metastatic solid tumors who can provide tumor biopsies, have recovered from previous treatments to a certain degree, and have measurable disease. They must be able to perform daily activities with minimal assistance (ECOG PS ≤1), have good organ/bone marrow function, use effective contraception if applicable, and not be pregnant.

What is being tested?

KD033 (SAR445710) is being tested in this Phase 1 study where participants receive varying doses either weekly or every two weeks. The goals are to determine the safety and tolerability of KD033, its potential anti-cancer effects, and how it's processed by the body.

What are the potential side effects?

While specific side effects for KD033 are not listed here as it's an early-stage trial assessing safety, common side effects may include reactions at the injection site, fatigue, nausea, fever-like symptoms due to immune system activation or other drug-related adverse events.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an expected average of 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an expected average of 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an expected average of 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Occurrence of Dose Limiting Toxicities (DLTs)

Treatment Emergent Adverse Events (TEAEs) and Treatment-related AEs by Severity

Secondary study objectives

Best Overall Response (BOR)

Duration Of Response (DOR)

Exploration of Anti-KD033 (SAR445710) Antibodies

+2 more

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: Weekly Monotherapy Dose Escalation (Q1W)Experimental Treatment1 Intervention

KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration once a week (QW) for 6 weeks and then every 2 week-dosing.

Group II: Dose ExpansionExperimental Treatment1 Intervention

KD033 (SAR445710) will be administered at recommended dose/schedule for expansion

Group III: Bi-weekly Monotherapy Dose Escalation (Q2W)Experimental Treatment1 Intervention

KD033 (SAR445710) will be administered in sequential ascending doses as a monotherapy via intravenous (IV) administration every 2 weeks (Q2W).

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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 immune checkpoint inhibitors, targeted therapies, and traditional chemotherapies. Immune checkpoint inhibitors enhance the immune system's ability to attack cancer cells by blocking proteins that inhibit immune responses. Targeted therapies disrupt specific molecular pathways essential for tumor growth and survival. Traditional chemotherapies kill rapidly dividing cells, including cancer cells, but can also affect normal cells. These mechanisms are important for solid tumor patients as they guide the selection of treatments that offer the best balance between efficacy and side effects.