OC-001 for Advanced Cancers

Recruiting at 5 trial locations

Overseen By Jennifer Curry

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Ocellaris Pharma, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: CNS metastasis, Organ transplant, Autoimmune, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called OC-001 for various types of advanced cancers. Researchers aim to evaluate how well OC-001 works alone and in combination with another drug, Avelumab. Individuals with certain advanced cancers who have not responded to standard treatments like chemotherapy might be suitable candidates. Participants should not have specific medical conditions, such as active autoimmune diseases or recent transplants, and should not be involved in other clinical trials. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I need to stop my current medications for the OC-001 trial?

The trial protocol does not specify if you need to stop taking your current medications, but you must stop any cancer-related treatments at least 21 days before joining the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that OC-001 is being tested alone to assess its safety and patient reactions. Previous studies have examined its safety when used without other treatments, aiming to identify potential side effects and their severity. Although specific details about side effects are not yet available, the trial remains in early stages, and scientists continue to learn about its safety.

For the combination of OC-001 with Avelumab, research indicates that Avelumab has been well-studied independently. Past studies have shown it to be generally safe, with no new safety concerns identified. This suggests that adding Avelumab to treatments usually does not cause unexpected problems. However, scientists are still exploring how patients handle the combination of OC-001 and Avelumab.

Overall, while OC-001 alone and with Avelumab is still under study, existing information on Avelumab's safety aids in understanding its role in the combination treatment. However, OC-001’s complete safety profile is still being investigated. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for advanced cancers, which often focus on traditional chemotherapy or targeted therapies, OC-001 represents a new approach by combining immune system activation with direct cancer cell targeting. Researchers are excited about OC-001 because it is administered intravenously in combination with Avelumab, an immunotherapy that boosts the body's ability to fight cancer. This combination could potentially enhance the effectiveness of the treatment by not only attacking the cancer cells directly but also engaging the immune system to sustain the attack. Additionally, OC-001's unique delivery method allows for dose escalation, which helps optimize the treatment's effectiveness while managing side effects.

What evidence suggests that this trial's treatments could be effective for advanced cancers?

Research shows that OC-001 is under investigation as a new cancer treatment in this trial. The main goal is to determine its safety and tolerability for patients. Early studies suggest that OC-001 might enhance the immune system's ability to fight cancer. In this trial, some participants will receive OC-001 alone, while others will receive it with Avelumab, a drug already used for certain cancers. The combination aims to strengthen the body's ability to combat cancer cells. Studies have shown that Avelumab can help prevent cancer progression, especially in some advanced cases. This ongoing research aims to demonstrate that these treatments can work together to improve outcomes for patients with advanced cancers. ^{2 6 7 8 9}

Who Is on the Research Team?

Ocellaris Pharma, Inc

Principal Investigator

Ocellaris Pharma, Inc.

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Have an estimated life expectancy of at least 3 months

Standard treatments have not worked for me, or I have refused them.

I agree to use effective birth control during and for 12 weeks after the study.

Exclusion Criteria

I haven't had any autoimmune diseases in the last 2 years, except for vitiligo, Grave's disease, or psoriasis not needing systemic treatment.

Are currently enrolled in another clinical study of an investigational medicinal product

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1b: Dose Escalation (Monotherapy)

Escalating doses of OC-001 administered intravenously (IV) to determine safety and pharmacokinetics

12 weeks

Phase 1b: Dose Escalation (Combination Therapy)

Escalating doses of OC-001 administered by IV in combination with Avelumab to determine safety and pharmacokinetics

12 weeks

Phase 2a

Doses of OC-001 administered by IV in combination with Avelumab to evaluate safety and efficacy

up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OC-001

Trial Overview 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.

How Is the Trial Designed?

Group I: Drug: Phase 2a Experimental Treatment 1 Intervention

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

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

Escalating doses of OC-001 administered intravenously (IV)

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

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

Who Is Running the Clinical Trial?

Ocellaris Pharma, Inc.

Lead Sponsor

Trials

1

Recruited

120+

Citations

1. annalsofoncology.org annalsofoncology.org/article/S0923-7534(22)02720-X/fulltext

743P A phase Ib dose escalation study of CD137 mAb ... The primary objective of this study is to assess the safety and tolerability of OC-001 administered as a monotherapy in patients with selected locally advanced ...

2. ctv.veeva.com ctv.veeva.com/study/a-study-to-evaluate-the-safety-and-pharmacokinetics-of-oc-001-in-patients-with-locally-advanced-or-m

A Study to Evaluate the Safety and Pharmacokinetics of OC ... This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types.

3. withpower.com withpower.com/trial/phase-2-neoplasm-metastasis-9-2020-1c48f

OC-001 for Advanced Cancers This trial is testing a new treatment called OC-001, both by itself and with other drugs that help the immune system fight cancer.

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.e17570

Efficacy and safety of envafolimab plus lenvatinib ... We aim to assess the efficacy and safety of the combination therapy of envafolimab plus lenvatinib combined with etoposide in patients with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10847356/

Clinical benefit analysis of PD-1 inhibitors in patients with ... This study aims to comprehensively evaluate the efficacy and safety of programmed cell death protein-1 (PD-1) in patients with advanced, recurrent, or ...

6. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/254319

A Study to Evaluate the Safety and Pharmacokinetics of OC ... This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10685024/

Avelumab first-line maintenance treatment for advanced ... No new safety signals were seen in patients who received ≥1 year of avelumab treatment, and toxicity was similar in those who had received cisplatin or ...

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2722623

Efficacy and Safety of Avelumab for Patients With ... Avelumab demonstrated antitumor activity and an acceptable safety profile in heavily pretreated patients with recurrent or refractory ovarian cancer.

9. clinicaltrials.gov clinicaltrials.gov/study/NCT01772004

Avelumab in Metastatic or Locally Advanced Solid Tumors ... A Phase I, Open-label, Multiple-ascending Dose Trial to Investigate the Safety, Tolerability, Pharmacokinetics, Biological and Clinical Activity of Avelumab