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NCT02636036: SPICE
Phase I Study of Enadenotucirev and PD-1 Inhibitor in Subjects With Metastatic or Advanced Epithelial Tumors
Phase 1 trial testing enadenotucirev in Colorectal Cancer in 51 participants. Completed in 8 October 2021.
8 October 2021
Quick facts
| Lead sponsor | Akamis Bio |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 51 |
| Start date | 25 January 2016 |
| Primary completion | 8 October 2021 |
| Estimated completion | 8 October 2021 |
| Sites | 6 locations across United States |
Drugs / interventions tested
- enadenotucirev — full drug profile →
- nivolumab (nivolumab) — full drug profile →
Conditions studied
- Colorectal Cancer — all drugs for Colorectal Cancer →
- Squamous Cell Carcinoma of the Head and Neck — all drugs for Squamous Cell Carcinoma of the Head and Neck →
- Epithelial Tumor — all drugs for Epithelial Tumor →
Sponsor
Akamis Bio — full company profile →
Who can join
18 and older, any sex, with Colorectal Cancer or Squamous Cell Carcinoma of the Head and Neck. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with focus on CRC, SCCHN, escalation phase), not responding to standard therapy.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immunotherapy in colorectal cancer: current achievements and future perspective.
Fan A, Wang B, Wang X, Nie Y, et al · · 2021 · cited 321× · PMID 34671202 · DOI 10.7150/ijbs.64077 -
Review of PD-1/PD-L1 Inhibitors in Metastatic dMMR/MSI-H Colorectal Cancer.
Oliveira AF, Bretes L, Furtado I. · · 2019 · cited 152× · PMID 31139574 · DOI 10.3389/fonc.2019.00396 -
Cancer immunotherapy beyond immune checkpoint inhibitors.
Marin-Acevedo JA, Soyano AE, Dholaria B, Knutson KL, et al · · 2018 · cited 140× · PMID 29329556 · DOI 10.1186/s13045-017-0552-6 -
Biomarkers for immunotherapy in bladder cancer: a moving target.
Aggen DH, Drake CG. · · 2017 · cited 133× · PMID 29157296 · DOI 10.1186/s40425-017-0299-1 -
Phase 1 study of intravenous administration of the chimeric adenovirus enadenotucirev in patients undergoing primary tumor resection.
Garcia-Carbonero R, Salazar R, Duran I, Osman-Garcia I, et al · · 2017 · cited 131× · PMID 28923104 · DOI 10.1186/s40425-017-0277-7 -
Oncolytic Viruses: Priming Time for Cancer Immunotherapy.
Russell L, Peng KW, Russell SJ, Diaz RM. · · 2019 · cited 93× · PMID 31321623 · DOI 10.1007/s40259-019-00367-0 -
Oncolytic viruses encoding bispecific T cell engagers: a blueprint for emerging immunovirotherapies.
Heidbuechel JPW, Engeland CE. · · 2021 · cited 80× · PMID 33863363 · DOI 10.1186/s13045-021-01075-5 -
A phase 1 dose escalation study of the oncolytic adenovirus enadenotucirev, administered intravenously to patients with epithelial solid tumors (EVOLVE).
Machiels JP, Salazar R, Rottey S, Duran I, et al · · 2019 · cited 77× · PMID 30691536 · DOI 10.1186/s40425-019-0510-7
Verify or expand the search:
- PubMed search for NCT02636036
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Akamis Bio trials
Trials by the same sponsor.
- NCT06459869 — NG-350A Plus Chemoradiotherapy for Locally Advanced Rectal Cancer · Phase 1 · recruiting
- NCT05165433 — Study of NG-350A Plus Pembrolizumab in Metastatic or Advanced Epithelial Tumours (FORTIFY) · Phase 1 · completed
- NCT05043714 — Study of NG-641 in Combination With Nivolumab in Metastatic or Advanced Epithelial Tumours · Phase 1 · completed
- NCT04830592 — A Study of NG-641 and Pembrolizumab in Squamous Cell Carcinoma of the Head and Neck · Phase 1 · completed
- NCT04053283 — First in Human Study With NG-641, a Tumour Selective Transgene Expressing Adenoviral Vector · Phase 1 · completed
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 NCT02636036 (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 Akamis Bio
- Last refreshed: 9 November 2021
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/NCT02636036.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing