A Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours (NCT02521844)
A Phase 1A/B Study to Evaluate the Safety and Tolerability of ETC-1922159 as a Single Agent and in Combination With Pembrolizumab in Advanced Solid Tumours
🩺 Plain-English Summary (8th-Grade Level)
This is a Phase 1A/B study consisting of four parts. 1. Part A (completed) is a non-randomised, open-label, sequential evaluation of the safety, pharmacokinetics (PK), maximum tolerated dose (MTD), and recommended dose (RD) of ETC-1922159 in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. Dose escalation, with the goal of identifying the MTD and RD, is guided by an ordinal continual reassessment method (oCRM) model with a cohort size of one patient. 2. Part A extension (completed) is a non-randomised, non-comparative, open-label evaluation of the safety and tolerability of ETC-1922159 together with the bone protective treatment (denosumab) in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. 3. Part B dose escalation (completed) is a non-randomised, open-label, sequential evaluation of the MTD, RD, safety, PK, and PD (pharmacodynamics) of ETC 1922159 in combination with pembrolizumab in patients with advanced or metastatic, or unresectable solid malignancies, for whom no approved treatment option or standard of care is available. 4. Part B dose expansion will be a non-randomised, non-comparative, open-label study evaluation of the safety and tolerability of ETC-1922159 as a single agent until disease progression and then in combination with pembrolizumab at the RD identified in the Part B dose escalation segment, in patients with advanced or metastatic, or unresectable solid malignancies that are refractory, intolerant or not suitable for available treatment according to the treating physician. It is anticipated that the study will take approximately 78 months to complete (36 months for Part A and Part A Extension, approximately 6 months for Part B dose escalation and approximately 36 months for Part B dose expansion).
Who can join: Review the eligibility criteria below.
Location: University of Arizona Cancer Center, 3838 N. Campbell Avenue, RM 2111, Site 203 — Tucson, Arizona
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- University of Arizona Cancer Center, 3838 N. Campbell Avenue, RM 2111, Site 203 — Tucson, Arizona
- Chao Family Comprehensive Cancer Center,Stern Center for Cancer Clinical Trials and Research, 101 City Drive South, Site 209 — Orange, California
- University of Colorado Hospital Anschutz Cancer Pavilion, 12648 East 17th Avenue; MSF 700, Site 202 — Aurora, Colorado
- University of Kansas Medical Center, 4350 Shawnee Mission Parkway, Suite 2310, MS 6004, Site 210 — Fairway, Kansas
- Washington University School of Medicine, Siteman Cancer Center, 4921 Parkview Place, Site 205 — St Louis, Missouri
- Duke University Medical Center, Duke Cancer Center, 20 Duke Medicine Circle, Site 206 — Durham, North Carolina
- Oregon Health and Science University-Knight Cancer Institute, 3485 S Bond Ave., Mail code 0C14CTSite 211 — Portland, Oregon
- Oregon Health and Science University, 3181 Southwest Sam Jackson Park Road, Mail Code Cr 9-4, Site 211 — Portland, Oregon
- Department of Investigational Cancer Therapeutics, 1400 Holcombe Blvd., Unit 455, Site 201 — Houston, Texas
- National University Hospital, 1E Kent Ridge Road, NUHS Tower Block, Level 7, Site 101 — Singapore,
- National Cancer Centre Singapore, 11 Hospital Drive, Site 102 — Singapore,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Study of Anti-CEACAM5 ADC M9140 in Participants With Advanced Solid Tumors (PROCEADE PanTumor) — Santa Monica, California
- A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial — Porto Alegre, Rio Grande do Sul
- Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors — Los Angeles, California
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.