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NCT01363947
Safety and Pharmacokinetics of Escalating Doses of DNIB0600A in Participants With Non-Small Cell Lung Cancer (NSCLC) and Platinum Resistant Ovarian Cancer
Phase 1 trial testing DNIB0600A in Non-Small Cell Lung Cancer, Ovarian Cancer in 87 participants. Completed in 3 June 2016.
3 June 2016
Quick facts
| Lead sponsor | Genentech, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 87 |
| Start date | 14 June 2011 |
| Primary completion | 3 June 2016 |
| Estimated completion | 3 June 2016 |
| Sites | 7 locations across United States, Spain |
Drugs / interventions tested
- DNIB0600A — full drug profile →
Conditions studied
- Non-Small Cell Lung Cancer, Ovarian Cancer — all drugs for Non-Small Cell Lung Cancer, Ovarian Cancer →
Sponsor
Genentech, Inc. — full company profile →
Who can join
18 and older, any sex, with Non-Small Cell Lung Cancer, Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Study DNB4987g is a Phase I, multicenter, open label, dose-escalation study of DNIB0600A administered as a single agent by intravenous (IV) infusion every three weeks (q3w) to participants with non-squamous NSCLC or non-mucinous, platinum-resistant ovarian cancer. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Drug resistance in ovarian cancer: from mechanism to clinical trial.
Wang L, Wang X, Zhu X, Zhong L, et al · · 2024 · cited 139× · PMID 38539161 · DOI 10.1186/s12943-024-01967-3 -
Exploration of the antibody-drug conjugate clinical landscape.
Maecker H, Jonnalagadda V, Bhakta S, Jammalamadaka V, et al · · 2023 · cited 90× · PMID 37639687 · DOI 10.1080/19420862.2023.2229101 -
Antibody-drug conjugates in lung cancer: dawn of a new era?
Coleman N, Yap TA, Heymach JV, Meric-Bernstam F, et al · · 2023 · cited 89× · PMID 36631624 · DOI 10.1038/s41698-022-00338-9 -
Clinical pharmacology of vc-MMAE antibody-drug conjugates in cancer patients: learning from eight first-in-human Phase 1 studies.
Li C, Zhang C, Li Z, Samineni D, et al · · 2020 · cited 44× · PMID 31852341 · DOI 10.1080/19420862.2019.1699768 -
Current Status of Marine-Derived Compounds as Warheads in Anti-Tumor Drug Candidates.
Newman DJ, Cragg GM. · · 2017 · cited 43× · PMID 28353637 · DOI 10.3390/md15040099 -
The clinical development of antibody-drug conjugates for non-small cell lung cancer therapy.
Liu X, Deng J, Zhang R, Xing J, et al · · 2023 · cited 15× · PMID 38162667 · DOI 10.3389/fimmu.2023.1335252 -
9th annual European Antibody Congress, November 11-13, 2013, Geneva, Switzerland.
Reichert JM, Beck A, Lugovskoy AA, Wurch T, et al · · 2014 · cited 12× · PMID 24492298 · DOI 10.4161/mabs.27903 -
A review of recent advances on single use of antibody-drug conjugates or combination with tumor immunology therapy for gynecologic cancer.
Wang AJ, Gao Y, Shi YY, Dai MY, et al · · 2022 · cited 10× · PMID 36618922 · DOI 10.3389/fphar.2022.1093666
Verify or expand the search:
- PubMed search for NCT01363947
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of DNIB0600A
Trials testing the same drug.
- NCT01991210 — A Study of DNIB0600A in Comparison With Pegylated Liposomal Doxorubicin (PLD) in Participants With Platinum-Resistant Ov · Phase 2 · terminated
- NCT01995188 — A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or N · Phase 1 · completed
Other Genentech, Inc. trials
Trials by the same sponsor.
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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 NCT01363947 (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 Genentech, Inc.
- Last refreshed: 7 June 2017
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/NCT01363947.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing