TerminatedPhase 1/2

A Study to Evaluate the Safety and Pharmacokinetics of OC-001 in Patients With Locally Advanced or Metastatic Cancers

Stopped: Business Decision

Canada73 participantsStarted 2020-09-24

Plain-language summary

This study will investigate OC-001 as monotherapy, and in combination with, Avelumab, in various cancer types

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Have the presence of evaluable disease for the Phase 1b Monotherapy
✓. Have the presence of evaluable and measurable disease for the Phase 1b combination part and the Phase 2a part of the study.
✓. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease or patients who have refused standard treatments.

✕. Have symptomatic central nervous system (CNS) metastasis. Patients with treated CNS metastases are eligible for this study if they are asymptomatic and off of corticosteroids for a minimum of 7 days. Patients with primary brain tumors are not eligible
✕. Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant
✕. Females who are pregnant or nursing
✕. Have known, symptomatic acquired immuno deficiency syndrome (AIDS) or active hepatitis A, B or C
✕. Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent
✕. Active or prior documented autoimmune disease within the past 2 years Patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are eligible
✕. Active or prior documented inflammatory bowel disease

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

Timeframe: Baseline through Cycle 1 (Day 28)

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

Timeframe: Baseline up to two years

NCT IDNCT04260802

SponsorOcellaris Pharma, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-07

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Have the presence of evaluable disease for the Phase 1b Monotherapy
✓. Have the presence of evaluable and measurable disease for the Phase 1b combination part and the Phase 2a part of the study.
✓. The patient must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their disease or patients who have refused standard treatments.

✕. Have symptomatic central nervous system (CNS) metastasis. Patients with treated CNS metastases are eligible for this study if they are asymptomatic and off of corticosteroids for a minimum of 7 days. Patients with primary brain tumors are not eligible
✕. Have a history of major organ transplant (e.g., heart, lungs, liver, and kidney) or an autologous or allogeneic hematopoietic stem cell transplant
✕. Females who are pregnant or nursing
✕. Have known, symptomatic acquired immuno deficiency syndrome (AIDS) or active hepatitis A, B or C
✕. Previous treatment-related, severe (≥Grade 3) Adverse Event (AE) or any neurologic or ocular AE while receiving an IO agent
✕. Active or prior documented autoimmune disease within the past 2 years Patients with vitiligo, Grave's disease or psoriasis not requiring systemic treatment within the past 2 years are eligible
✕. Active or prior documented inflammatory bowel disease