What side effects are associated with this type of intervention?

Common treatments for Neuroendocrine Carcinoma (NEC) include tyrosine kinase inhibitors (TKIs) like lenvatinib, which can cause side effects such as hypertension, renal toxicity, bleeding, myelosuppression, arterial thromboembolism, cardiotoxicity, thyroid dysfunction, cutaneous toxicity, delayed wound healing, hepatotoxicity, and muscle wasting. Peptide receptor radionuclide therapy (PRRT) with agents like 177Lu-DOTATATE can lead to nephrotoxicity, myelodysplastic syndrome, and acute myeloid leukemia, especially in heavily pretreated patients. Chemotherapy and other targeted therapies may also cause side effects like neuropathy, gastrointestinal disturbances, and hematologic toxicities.

What prior FDA approvals exist?

Several drugs have received FDA approval for the treatment of Neuroendocrine Carcinoma (NEC) and related conditions. These include everolimus, a mammalian target of rapamycin (mTOR) inhibitor, which has shown efficacy in treating advanced NETs, and sunitinib, a tyrosine kinase inhibitor, approved for progressive, well-differentiated pancreatic NETs. Additionally, immune checkpoint inhibitors like nivolumab and pembrolizumab have been explored for their anti-tumor activity in neuroendocrine tumors. These treatments share a focus on targeting tumor growth and progression, similar to the investigational drug RO7616789.

What other types of research exist?

Promising alternatives to RO7616789 for neuroendocrine carcinoma patients include sunitinib and everolimus. Sunitinib has shown significant antitumor activity with an objective response rate of 50% and a median progression-free survival of 16.8 months in patients with pancreatic neuroendocrine tumors. Everolimus is also a viable option, as it is being studied for its antiproliferative effects and has been included in cost-effectiveness models for neuroendocrine tumors. Both drugs have gained regulatory approval and are being investigated further for optimal patient selection and combination therapies.

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RO7616789 for Small Cell Lung Cancer

Phase 1

Recruiting

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Histologically confirmed extensive SCLC or poorly differentiated NEC of any other origin, relapsed after at least 1 systemic therapy

Must not have

Prior allogeneic hematopoietic stem cell transplantation or prior solid organ transplantation

History or clinical evidence of primary central nervous system (CNS) malignancy, symptomatic CNS metastases, CNS metastases requiring any anti-tumor treatment, or leptomeningeal disease and current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 26 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called RO7616789 to see if it is safe and effective for people with severe lung cancer and neuroendocrine carcinoma. The study will look at how the drug moves through the body and its effects on cancer cells.

Who is the study for?

This trial is for adults with advanced small cell lung cancer or neuroendocrine carcinoma who have relapsed after at least one systemic therapy. They should be able to live more than 12 weeks, be relatively active (ECOG status of 0 or 1), and have organs functioning well enough for treatment. Pregnant women can't participate, and participants must use contraception.

What is being tested?

The study tests RO7616789's safety and how it affects the body and tumors in patients with certain cancers. It has three parts: increasing doses to find a safe level (Dose Escalation) and then giving that dose to more people (Dose Expansion).

What are the potential side effects?

Possible side effects include typical reactions related to immune therapies such as inflammation in different parts of the body, infusion-related reactions, fatigue, changes in blood counts, increased risk of infections, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

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

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

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My small cell lung cancer or neuroendocrine cancer has returned after treatment.

Exclusion Criteria

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

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I have had a stem cell or organ transplant in the past.

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I do not have a history of brain cancer, untreated brain metastases, or major neurological conditions.

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I have had a severe immune reaction to previous cancer immunotherapy.

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I stopped an immune therapy due to a severe side effect, not including simple enzyme increases.

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My spinal cord compression hasn't been treated with surgery or radiation.

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My diabetes is not well-managed, with high blood sugar or A1c levels.

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I have not been treated with anti-CD137, anti-CD3, or DLL3 targeted therapies.

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I am currently taking medication that can affect my heart's rhythm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 26 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 26 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 26 months 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, 2 and 3: Number of Participants with Adverse Events and Serious Adverse Events

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 3: Dose ExpansionExperimental Treatment2 Interventions

Based on emerging data from Part 1 and 2, one or more dosing regimens will be further investigated in Part 3.

Group II: Part 2: RO7616789 Q3W: Dose EscalationExperimental Treatment2 Interventions

Participants will receive a fixed dose of RO7616789, at a dose determined in Part 1, intravenously once every 3 weeks (Q3W) on Day 1 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.

Group III: Part 1: RO7616789 QW: Dose EscalationExperimental Treatment2 Interventions

Participants will receive a fixed dose of RO7616789 intravenously once weekly (QW) per dose level on Day 1, 8, and 15 of each 21-day cycle. In case of toxicity, step-up (single or double) dosing may be explored.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

0 / 10Eligibility 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

The investigational drug RO7616789 is being studied for its anti-tumor activity in Neuroendocrine Carcinoma (NEC) by targeting specific pathways involved in tumor growth and progression. Similar treatments include tyrosine kinase inhibitors like cabozantinib, which block enzymes that promote cancer cell proliferation and angiogenesis. Somatostatin analogs, such as lanreotide, inhibit hormone secretion and tumor growth by binding to somatostatin receptors on tumor cells. Peptide receptor radionuclide therapy (PRRT) uses radiolabeled somatostatin analogs to deliver targeted radiation to tumor cells, causing DNA damage and cell death. Understanding these mechanisms is crucial for NEC patients as it helps in selecting the most effective treatment based on the tumor's specific characteristics and receptor expression.