What is the mechanism of action of this treatment?

Common treatments for Neuroendocrine Carcinoma (NEC) include somatostatin analogs like lanreotide and octreotide, which inhibit hormone secretion and tumor growth, and immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors, which enhance the immune system's ability to target cancer cells. The combination of these treatments can provide a dual approach: controlling tumor growth and enhancing immune response. This is particularly relevant for NEC patients as these tumors often express specific receptors and antigens that can be targeted by these therapies, potentially leading to more effective and durable treatment outcomes. The investigational agent OC-001, when combined with PD-1/PD-L1 inhibitors, may further enhance this immune response, offering a promising new avenue for NEC treatment.

What side effects are associated with this type of intervention?

Common treatments for Neuroendocrine Carcinoma, particularly those involving immune checkpoint inhibitors like PD-1/PD-L1 inhibitors, can lead to side effects such as fatigue, nausea, diarrhea, and immune-related adverse events like rash and colitis. Somatostatin analogs, such as lanreotide and octreotide, are generally well-tolerated but can cause gastrointestinal disturbances and gallstones. Targeted therapies like everolimus and sunitinib may result in side effects including stomatitis, rash, diarrhea, and hand-foot syndrome. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

For the treatment of Neuroendocrine Carcinoma, the FDA has approved several drugs that enhance the immune response. Notably, immune checkpoint inhibitors such as pembrolizumab (a PD-1 inhibitor) have shown promise in treating various cancers, including neuroendocrine tumors. Additionally, combinations of immunotherapy with other agents, such as pembrolizumab with lenvatinib, have been explored for their synergistic effects. These treatments aim to boost the body's immune response to target and destroy cancer cells, similar to the potential mechanism of action for OC-001 when combined with PD-1/PD-L1 inhibitors.

What other types of research exist?

Promising alternatives to OC-001 for Neuroendocrine Carcinoma patients include: 1) Ipilimumab plus Nivolumab, which demonstrated a 44% overall response rate (ORR) in high-grade nonpancreatic neuroendocrine carcinoma. 2) Temozolomide and Capecitabine combination, which has shown activity in some gastrointestinal neuroendocrine tumors (GINETs). 3) Everolimus, which has been effective in advanced, non-functional, well-differentiated neuroendocrine tumors of the gastrointestinal tract or lung. These options should be discussed with a healthcare provider to determine the best course of action based on individual patient characteristics.

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OC-001 for Advanced Cancers

Phase 1 & 2

Recruiting

Research Sponsored by Ocellaris Pharma, Inc.

Eligibility Criteria Checklist

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

Must have

For Phase 2a: Must have histological or cytological confirmation of a solid tumor that is locally advanced or metastatic. At least one cancer type will be selected amongst the ones evaluated in the Phase 1b part of the study

Have histological or cytological evidence of a diagnosis of selected cancer types that is locally advanced and/or metastatic

Must not have

Current or prior use of immunosuppressive medication within 28 days prior

Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to two years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment called OC-001, both by itself and with other drugs that help the immune system fight cancer. It aims to help patients with various types of cancer by making their immune system better at attacking cancer cells.

Who is the study for?

This trial is for adults with various advanced or metastatic cancers who've had 1-4 prior treatments and have measurable disease. They must be recovering from previous therapies, not pregnant or nursing, agree to contraception, have a life expectancy of at least 3 months, and adequate organ function. Excluded are those with severe treatment-related side effects, symptomatic brain tumors, major organ transplants, recent immunosuppressants use, certain autoimmune diseases or infections.

What is being tested?

OC-001 is being tested both alone and in combination with PD-1/PD-L1 inhibitors across different cancer types. The study aims to evaluate the safety and how the body processes OC-001. It's divided into two parts: Phase 1b tests evaluable disease cases; Phase 2a focuses on measurable disease in selected cancers from Phase 1b.

What are the potential side effects?

Potential side effects may include reactions typical of cancer therapies such as immune-related conditions due to PD-1/PD-L1 inhibition (like inflammation), fatigue, digestive issues like nausea or diarrhea, skin reactions and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

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

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My cancer is confirmed to be advanced or has spread, and it's one of the types studied previously.

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My cancer is advanced or has spread to other parts of my body.

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I stopped all cancer treatments at least 3 weeks ago.

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My cancer can be measured or evaluated for the study.

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I've had 1 to 4 treatments for my advanced or spreading cancer.

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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 haven't taken immunosuppressive drugs in the last 28 days.

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I have had a major organ or stem cell transplant.

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I have had tuberculosis, lung conditions, or lung inflammation treated with steroids.

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I have had a severe reaction to immunotherapy.

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I am not pregnant or nursing.

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I have or had inflammatory bowel disease.

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I have not received a live vaccine in the last 28 days.

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I have another type of cancer that could interfere with the study results.

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I do not have AIDS or active hepatitis A, B, or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to two years

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

Number of participants with a Dose Limiting Toxicity (DLT) in Phase 1b

Number of participants with any Serious Adverse Event or Treatment-Emergent Adverse Event in Phase 2a

Secondary study objectives

Area Under the OC-001 Plasma Concentration Time Curve (AUC) in Phase 1b

Disease Control Rate (DCR) in Phase 2a

Duration of Response (DOR) in Phase 2a

+11 more

Side effects data

From 2020 Phase 2 trial • 19 Patients • NCT03006848

17%

Musculoskeletal and connective tissue disorders

11%

Injury, poisoning and procedural complications

General disorders and administration site conditions

Metabolism and nutrition disorders

Nervous system disorders

Endocrine disorders

Investigations

Cardiac disorders

Gastrointestinal disorders

Infections and infestations

Immune system disorders

Blood and lymphatic system disorders

Neoplasms benign, malignant and unspecified

Respiratory, thoracic and mediastinal disorders

Renal and urinary disorders

Skin and subcutaneous tissue disorders

100%

80%

60%

40%

20%

Study treatment Arm

Avelumab

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: Drug: Phase 2aExperimental Treatment1 Intervention

Doses of OC-001 administered by IV in combination with Avelumab b)

Group II: Drug: Phase 1b: Dose Escalation (monotherapy)Experimental Treatment1 Intervention

Escalating doses of OC-001 administered intravenously (IV)

Group III: Drug: Phase 1b Dose: Escalation (Combination therapy)Experimental Treatment1 Intervention

Escalating doses of OC-001 administered by IV in combination Avelumab.

0 / 15Eligibility 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 Neuroendocrine Carcinoma (NEC) include somatostatin analogs like lanreotide and octreotide, which inhibit hormone secretion and tumor growth, and immune checkpoint inhibitors such as PD-1/PD-L1 inhibitors, which enhance the immune system's ability to target cancer cells. The combination of these treatments can provide a dual approach: controlling tumor growth and enhancing immune response. This is particularly relevant for NEC patients as these tumors often express specific receptors and antigens that can be targeted by these therapies, potentially leading to more effective and durable treatment outcomes. The investigational agent OC-001, when combined with PD-1/PD-L1 inhibitors, may further enhance this immune response, offering a promising new avenue for NEC treatment.

Expanding Therapeutic Options for Older Adults: Case-Based Updates in Breast and Lung Cancer.Combinatorial therapy of immune checkpoint and cancer pathways provides a novel perspective on ovarian cancer treatment.Expanding the Indication for Novel Theranostic 177Lu-Dotatate Peptide Receptor Radionuclide Therapy: Proof-of-Concept of PRRT in Merkel Cell Cancer.