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Monoclonal Antibodies

ONC-392 + Pembrolizumab for Non-Small Cell Lung Cancer (PRESERVE-001 Trial)

Phase 1 & 2

Recruiting

Led By Tianhong Li, MD

Research Sponsored by OncoC4, Inc.

Eligibility Criteria Checklist

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

Must have

Patient must have a performance status of 0 or 1 on the ECOG Performance Scale

Female and Male patients must agree to use adequate methods of contraception starting with the first dose of study drug through 90 days after the last dose of study therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

PRESERVE-001 Trial Summary

This trial is testing a new drug, ONC-392, as a possible treatment for advanced or metastatic solid tumors and non-small cell lung cancers. The trial will test different doses of the drug to see what is safe and what works best. The trial will also test ONC-392 in combination with another drug, pembrolizumab.

Who is the study for?

Adults over 18 with certain advanced solid tumors or NSCLC, who have measurable disease and are in good physical condition. They must not be on high-dose steroids, pregnant, breastfeeding, or have brain metastases. Participants need functioning organs and agree to use contraception.Check my eligibility

What is being tested?

The trial is testing ONC-392 alone and combined with Pembrolizumab in patients with various cancers including NSCLC. It's a first-in-human study assessing safety, how the body processes the drug (pharmacokinetics), and effectiveness.See study design

What are the potential side effects?

Potential side effects include immune-related reactions due to ONC-392 or Pembrolizumab such as inflammation of organs, infusion reactions like fever or chills, fatigue, skin rash, digestive issues like diarrhea or liver enzyme changes.

PRESERVE-001 Trial Eligibility Criteria

Inclusion Criteria

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

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I am fully active or restricted in physically strenuous activity but can do light work.

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I agree to use birth control from the first to 90 days after the last dose of the study drug.

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My organ functions are within normal ranges according to recent tests.

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I have a confirmed diagnosis of NSCLC or another type of cancer, with it spreading or getting worse.

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My adenoid cystic carcinoma has worsened in the last 12 months.

PRESERVE-001 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one year

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose limiting toxicity (DLT) in monotherapy

Maximal tolerable dose (MTD) in monotherapy

Rate of treatment related adverse events (TRAE) according to CTCAE v5.0

+1 more

Secondary outcome measures

Objective Response Rate (ORR)

Overall Survival (OS)

Progression Free Survival (PFS)

+2 more

PRESERVE-001 Trial Design

2Treatment groups

Experimental Treatment

Group I: ONC-392 in combination with pembrolizumabExperimental Treatment2 Interventions

The Part B1 study will test ONC-392 intravenous (IV) infusion, Q3W, in combination with fixed dose of pembrolizumab. The dose for pembrolizumab will be fixed at 200mg/cycle dosed every 21 days (Q3W). The Part B1 will start at one level below RP2D-M dose for ONC-392 and 200mg of pembrolizumab. When 2 DLTs occur before 6 patients are enrolled, the ONC-392 dose will be decreased to the next dose level until ≤ 1/6 patients treated at that dose develops a DLT. This dose level will be designated RP2D-C. In Part C, the expansion cohorts Arm D to G will assess the safety and efficacy of ONC-392 in different dose levels and Pembrolizumab combination therapy in non small cell lung cancer, and metastatic melanoma.

Group II: ONC-392 Treatment as single agentExperimental Treatment1 Intervention

The Part A study will test ONC-392 intravenous (IV) infusion up to five predefined dose levels from 0.1 mg/kg to 10 mg/kg ONC-392 as monotherapy every 21 days (Q3W). The Part A study will determine the maximal tolerable dose (MTD) and the recommended Phase 2 dose in monotherapy (RP2D-M). In Part C, Arms A-C, I-N monotherapy expansion cohorts will further assess the safety and efficacy of ONC-392 in different dose levels as monotherapy in pancreatic cancer, triple negative breast cancer, non small cell lung cancer with driver mutations, PD-1 resistant non small cell lung cancer, PD-1 resistant melanoma, head and neck cancer, ovarian cancer, renal cell carcinoma and other solid tumors. Part D is a Phase II study on recurrent and/or metastatic adenoid cystic carcinoma.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 2

~2010

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

OncoC4, Inc.Lead Sponsor

6 Previous Clinical Trials

850 Total Patients Enrolled

1 Trials studying Ovarian Cancer

58 Patients Enrolled for Ovarian Cancer

National Cancer Institute (NCI)NIH

13,665 Previous Clinical Trials

40,924,940 Total Patients Enrolled

285 Trials studying Ovarian Cancer

72,852 Patients Enrolled for Ovarian Cancer

Tianhong Li, MDPrincipal InvestigatorUniversity of California, Davis

Media Library

Ovarian Cancer Clinical Trial 2023: ONC-392 Highlights & Side Effects. Trial Name: NCT04140526 — Phase 1 & 2

ONC-392 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04140526 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the ultimate goal of this experiment?

"This 21-day trial will measure the Maximum Tolerable Dose (MTD) when used as monotherapy. Secondary goals include measuring Objective Response Rate (ORR), Progression Free Survival (PFS), and Overall Survival (OS). These metrics are determined by standards such as RECIST v1.1 and iRECIST."

Answered by AI

Has Pembrolizumab been researched as part of any other investigations?

"Pembrolizumab first appeared in the City of Hope's research back in 2010, with 281 clinical trials having been completed by now. There are presently 1061 active experiments occurring across various locations, particularly Greenville, South carolina."

Answered by AI

Are there vacancies left in this trial for participants?

"Affirmative. The information on clinicaltrials.gov demonstrates that this study is in the midst of recruiting patients, with an initial post date of 9/16/2020 and a subsequent edit made on 10/12/2022. A total of 468 participants need to be acquired for the trial from 36 different medical facilities."

Answered by AI

How many participants are enrolled in this research endeavor?

"Affirmative. The clinicaltrials.gov record indicates that this experiment is actively recruiting, with an initial posting of September 16th 2020 and a recent amendment on October 12th 2022. Moreover, 468 volunteers are required to be enrolled at 36 different medical centres across the country."

Answered by AI

How many facilities are currently hosting this research endeavor in the city?

"Numerous healthcare facilities are participating in this trial, including Prisma Health based in Greenville and Pennsylvania Cancer Specialists & Research Institute (Formerly Gettysburg Cancer Center) situated in Gettysburg. Additionally, The Oncology Institute of Hope and Innovation is located Downey and offers enrolment into the study."

Answered by AI