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NCT01995188
A Study to Evaluate the Safety and Pharmacology of DNIB0600A in Participants With Platinum-Sensitive Ovarian Cancer or Non-Squamous Non-small Cell Lung Cancer
Phase 1 trial testing Bevacizumab in Non-Squamous Non-Small Cell Lung Cancer in 41 participants. Completed in 9 November 2016.
9 November 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 | 41 |
| Start date | 16 December 2013 |
| Primary completion | 9 November 2016 |
| Estimated completion | 9 November 2016 |
| Sites | 4 locations across United States |
Drugs / interventions tested
- Bevacizumab (Bevacizumab-Bvzr) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
- DNIB0600A — full drug profile →
Conditions studied
- Non-Squamous Non-Small Cell Lung Cancer — all drugs for Non-Squamous Non-Small Cell Lung Cancer →
Sponsor
Genentech, Inc. — full company profile →
Who can join
18 and older, any sex, with Non-Squamous Non-Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This open-label, multicenter, phase 1b study will evaluate the safety and pharmacokinetics of DNIB0600A in participants with platinum-sensitive ovarian cancer (PSOC) or Non-Squamous Non-small Cell Lung Cancer (NSCLC). The maximum tolerated dose of intravenously infused DNIB0600A in combination with carboplatin will be determined in escalating dose cohorts. The combination of DNIB0600A and carboplatin will then be evaluated with and without bevacizumab \[Avastin\] in three dose expansion cohorts.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
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 -
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 -
Trial watch: Tumor-targeting monoclonal antibodies for oncological indications.
Vacchelli E, Pol J, Bloy N, Eggermont A, et al · · 2015 · cited 32× · PMID 25949870 · DOI 10.4161/2162402x.2014.985940 -
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 -
Therapeutic targets and new directions for antibodies developed for ovarian cancer.
Bax HJ, Josephs DH, Pellizzari G, Spicer JF, et al · · 2016 · cited 14× · PMID 27494775 · DOI 10.1080/19420862.2016.1219005 -
Lung cancer organoid-based drug evaluation models and new drug development application trends.
Lee E, Lee SY, Seong YJ, Ku B, et al · · 2024 · cited 4× · PMID 39830742 · DOI 10.21037/tlcr-24-603 -
Therapeutic landscape of ovarian cancer: recent advances and emerging therapies.
Wang L, Zhang Q, Wang X, Dong Z, et al · · 2025 · cited 2× · PMID 40797342 · DOI 10.1186/s40364-025-00818-7
Verify or expand the search:
- PubMed search for NCT01995188
- 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 NCT01995188 (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: 4 October 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/NCT01995188.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing