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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
Must not have
Patients who are on chronic systemic steroid therapy at doses >10 mg/day
Patients who have active symptomatic brain metastasis or leptomeningeal metastasis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am on long-term steroid treatment with doses over 10 mg/day.
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I have active brain or spinal cord cancer symptoms.

Timeline

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

Trial Design

3Treatment 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 and docetaxelExperimental Treatment2 Interventions
Part E Arm O will test ONC-392 in combination with docetaxel, IV infusion, Q3W, in PD-1 resistant NSCLC patients.
Group III: 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
Docetaxel
1995
Completed Phase 4
~5620
Pembrolizumab
2017
Completed Phase 2
~2010

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for ovarian cancer include chemotherapy, targeted therapy, and immunotherapy. Chemotherapy works by killing rapidly dividing cancer cells, while targeted therapies, such as PARP inhibitors, interfere with specific molecular pathways involved in cancer cell survival. Immunotherapy, including anti-CTLA4 monoclonal antibodies like ONC-392, enhances the immune system's ability to recognize and destroy cancer cells by blocking inhibitory signals that prevent immune activation. This is crucial for ovarian cancer patients as it offers a potential for more effective and personalized treatment options, especially for those with advanced or resistant disease.
Defining the molecular response to trastuzumab, pertuzumab and combination therapy in ovarian cancer.

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
13,748 Previous Clinical Trials
40,958,668 Total Patients Enrolled
288 Trials studying Ovarian Cancer
72,972 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
~244 spots leftby Jun 2026
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