# Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC

Source: https://onco.cc/trials/nct04140526/  
OnCo record `nct04140526` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 1/2 trial of Gotistobart, Pembrolizumab, Docetaxel in non-small-cell lung cancer and small-cell lung cancer, run by OncoC4, Inc., active and no longer recruiting.

## Summary

Safety, PK and Efficacy of ONC-392 in Monotherapy and in Combination of Anti-PD-1 in Advanced Solid Tumors and NSCLC is a phase 1/2 interventional study registered as NCT04140526 by OncoC4, Inc., with 733 participants planned, started 2020-09-16 and due to reach its primary completion in 2026-12-31. Interventions recorded: ONC-392, Pembrolizumab, Docetaxel. Conditions listed: Non Small Cell Lung Cancer, Advanced Solid Tumor, Metastatic Melanoma, Metastatic Head and Neck Carcinoma. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: ctgov-ingest
- Registry id: NCT04140526
- Phase: 1/2
- Setting: Safety, Pharmacokinetics (PK), and Efficacy of ONC-392 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumors and NSCLC: An Open Label Phase IA/IB Study. Preserve CTLA4 Checkpoint Function (PRESERVE-001)
- Sponsor: OncoC4, Inc.
- Enrolled: 733

## Sources

- ClinicalTrials.gov NCT04140526: https://clinicaltrials.gov/study/NCT04140526

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/), [Melanoma](https://onco.cc/cancers/melanoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Renal cell carcinoma](https://onco.cc/cancers/rcc/), [Small-cell lung cancer](https://onco.cc/cancers/sclc/)
- drugs: [Docetaxel](https://onco.cc/drugs/docetaxel/), [Gotistobart](https://onco.cc/drugs/gotistobart/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [OncoC4](https://onco.cc/companies/oncoc4/)

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