Trial · NCT04140526
Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
NCT04140526, Phase 1, Phase 2, Active not recruiting, OncoC4, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC. Trials, record NCT04140526. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04140526
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC
- NCT number
- NCT04140526
- Status
- Active not recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 733 participants, estimated
- Lead sponsor
- OncoC4, Inc.
- Conditions
Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma, Metastatic Head and Neck Carcinoma, Metastatic Renal Cell Carcinoma, Metastatic Colorectal Cancer, Sarcomas, Metastatic Prostate Cancer, Ovarian Cancer, Small Cell Lung Cancer, Metastatic Breast Cancer, Pancreas Cancer, Gastric Cancer, Esophageal Cancer, Gastroesophageal Junction Adenocarcinoma, Cervical Cancer, Adenoid Cystic Carcinoma, Salivary Gland Cancer, Urothelial Carcinoma
- Interventions
- ONC-392, Pembrolizumab, Docetaxel
- First posted
- 2019-10-28
- Last updated
- 2026-09-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Dose limiting toxicity (DLT) in monotherapy | 21 days | The number of subjects who have dose limiting toxicity during the first cycle of study drug, ONC-392, administration. |
| Primary | Maximal tolerable dose (MTD) in monotherapy | 21 days | The study drug, ONC-392, dose level that has two out of six subjects who have dose limiting toxicity. |
| Primary | Recommended Phase II Dose (RP2D) | 21 days | The study drug, ONC-392, dose level that is one level below MTD, or an intermediate dose level that below MTD and pre-specified in protocol. This dose level will be the RP2D for monotherapy. |
| Primary | Rate of treatment related adverse events (TRAE) according to CTCAE v5.0 | One year | The safety profile will be presented as tabulated TRAE. |
| Secondary | The serum half life of the study drug, ONC-392, in monotherapy. | 12 weeks | To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life. |
| Secondary | The serum half life of the study drug, ONC-392, in combination therapy with Pembrolizumab. | 12 weeks | To determine the drug concentration in serum samples that are taken in various timepoints during the treatment in order to calculate drug half life. |
| Secondary | Objective Response Rate (ORR) | 1 year | To determine the objective response rate based on RECIST v1.1. |
| Secondary | Progression Free Survival (PFS) | 1 year | To determine the progression free survival based on RECIST 1.1 and iRECIST. |
| Secondary | Overall Survival (OS) | 1 year | To determine the overall survival. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| R44CA250824 | First in Human Phase I/II clinical trial of ONC-392: Preserving CTLA-4 immune tolerance checkpoint for safer and more effective cancer immunotherapy | ZHENG, PAN; HE, KAI; LI, TIANHONG | ONCOC4, INC. | NATIONAL CANCER INSTITUTE | 2020 to 2022 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04140526
GET https://conductscience.org/api/trials/v1/NCT04140526/registered