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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline up to two years
Awards & highlights

Study Summary

This trial will study the effects of OC-001 on different types of cancer, both by itself and in combination with other drugs.

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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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
+10 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Drug: Dose EscalationExperimental Treatment1 Intervention
Escalating doses of OC-001 administered intravenously (IV)
Group II: Drug: Combination: Tumor Type 2Experimental Treatment1 Intervention
Doses of OC-001 administered by IV in combination anti-PD-1 or anti-PD-L1 Antibody (Ab)
Group III: Drug: Combination: Tumor Type 1Experimental Treatment1 Intervention
Doses of OC-001 administered by IV in combination anti-PD-1 or anti-PD-L1 Antibody (Ab)

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Who is running the clinical trial?

Ocellaris Pharma, Inc.Lead Sponsor
Ocellaris Pharma, IncStudy DirectorOcellaris Pharma, Inc.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers
2020. "A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04260802.
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