OC-001 for Advanced Cancers

Recruiting in Palo Alto (17 mi)

+4 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Ocellaris Pharma, Inc.

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: CNS metastasis, Organ transplant, Autoimmune, others

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

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.

Research Team

Ocellaris Pharma, Inc

Principal Investigator

Ocellaris Pharma, Inc.

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• OC-001 (Virus Therapy)

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.

Participant Groups

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+