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NCT04006301
First-in-Human Study of JNJ-74699157 in Participants With Tumors Harboring the KRAS G12C Mutation
Phase 1 trial testing JNJ-74699157 in Neoplasms in 10 participants. Completed in 13 July 2020.
13 July 2020
Quick facts
| Lead sponsor | Janssen Research & Development, LLC |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 26 July 2019 |
| Primary completion | 13 July 2020 |
| Estimated completion | 13 July 2020 |
| Sites | 7 locations across France, United States |
Drugs / interventions tested
- JNJ-74699157 — full drug profile →
Conditions studied
- Neoplasms — all drugs for Neoplasms →
- Advanced Solid Tumors — all drugs for Advanced Solid Tumors →
- Non-small Cell Lung Cancer — all drugs for Non-small Cell Lung Cancer →
- Colorectal Cancer — all drugs for Colorectal Cancer →
Sponsor
Janssen Research & Development, LLC — full company profile →
Who can join
18 and older, any sex, with Neoplasms or Advanced Solid Tumors. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to determine the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) of JNJ-74699157 in participants with advanced solid tumors harboring a kirsten rat sarcoma virus homolog (KRAS) glycine-to-cysteine (G12C) mutation (Part 1: Dose escalation) and to determine the safety and preliminary antitumor activity of JNJ-74699157 at the RP2D regimen in participants with advanced solid tumors harboring a KRAS G12C mutation (Part 2: Dose expansion).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
RAS-targeted therapies: is the undruggable drugged?
Moore AR, Rosenberg SC, McCormick F, Malek S. · · 2020 · cited 832× · PMID 32528145 · DOI 10.1038/s41573-020-0068-6 -
KRAS mutation: from undruggable to druggable in cancer.
Huang L, Guo Z, Wang F, Fu L. · · 2021 · cited 728× · PMID 34776511 · DOI 10.1038/s41392-021-00780-4 -
The MAPK and AMPK signalings: interplay and implication in targeted cancer therapy.
Yuan J, Dong X, Yap J, Hu J. · · 2020 · cited 388× · PMID 32807225 · DOI 10.1186/s13045-020-00949-4 -
The current state of the art and future trends in RAS-targeted cancer therapies.
Punekar SR, Velcheti V, Neel BG, Wong KK. · · 2022 · cited 382× · PMID 36028717 · DOI 10.1038/s41571-022-00671-9 -
Tumor biomarkers for diagnosis, prognosis and targeted therapy.
Zhou Y, Tao L, Qiu J, Xu J, et al · · 2024 · cited 379× · PMID 38763973 · DOI 10.1038/s41392-024-01823-2 -
Role of oncogenic KRAS in the prognosis, diagnosis and treatment of colorectal cancer.
Zhu G, Pei L, Xia H, Tang Q, et al · · 2021 · cited 342× · PMID 34742312 · DOI 10.1186/s12943-021-01441-4 -
Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z -
Targeting KRAS(G12C): From Inhibitory Mechanism to Modulation of Antitumor Effects in Patients.
Kim D, Xue JY, Lito P. · · 2020 · cited 179× · PMID 33065029 · DOI 10.1016/j.cell.2020.09.044
Verify or expand the search:
- PubMed search for NCT04006301
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04006301 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Janssen Research & Development, LLC
- Last refreshed: 6 November 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04006301.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing